CONNECTS Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue)
Acronym
NECTAR
Organization
Vanderbilt University Medical CenterOTHER
Status Module
Record Verification Date
Dec 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 15, 2021Actual
Primary Completion Date
Oct 25, 2023Actual
Completion Date
Dec 31, 2023Actual
First Submitted Date
Jun 9, 2021
First Submission Date that Met QC Criteria
Jun 10, 2021
First Posted Date
Jun 14, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Oct 1, 2024
Results First Submitted that Met QC Criteria
Dec 30, 2024
Results First Posted Date
Jan 22, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 30, 2024
Last Update Posted Date
Jan 22, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sean Collins, Professor, Emergency Medicine, Vanderbilt University Medical CenterSponsor-Investigator
Lead Sponsor
Sean CollinsOTHER
Collaborators
Name
Class
National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. The primary analysis will include data from NCT05593770.
Detailed Description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), has resulted in a global pandemic. The clinical spectrum of COVID-19 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and death. Between 13 and 40% of patients become hospitalized, up to 30% of those hospitalized require admission for intensive care, and there is a 13% inpatient mortality rate. The reasons for hospitalization include respiratory support, as well as support for failure of other organs, including the heart and kidneys. The risk of thrombotic complications is increased, even when compared to other viral respiratory illnesses, such as influenza. While 82% of hospitalized patients with COVID-19 are ultimately discharged alive, median length of stay is 10-13 days.
Early work in treating COVID-19 has focused on preventing worsening of the initial clinical presentation to prevent hospitalization and disease progression to organ failure and death. Studies conducted under this Master Host Tissue Protocol are expected to extend our knowledge of how to manage patients who are hospitalized for COVID-19 illness. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. This Master Protocol is a randomized, placebo-controlled trial of agents targeting the host response in COVID-19 in hospitalized patients with hypoxemia. The Master Host Tissue Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Our primary outcome is oxygen free days through day 28. This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days.
April 20, 2022 TRV027 and TXA127 arms closed to accrual.
Conditions Module
Conditions
COVID-19
SARS-CoV-2 Infection
Coronavirus Infection
Keywords
COVID-19 drug treatment
RAAS
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,060Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TXA127 (4/20/2022 Arm Closed to Accrual)
Experimental
An investigational peptide agonist of Mas receptors.
Drug: TXA127
TRV027 (4/20/2022 Arm Closed to Accrual)
Experimental
An investigational peptide biased agonist of the AT1 receptor.
Drug: TRV027
Placebo
Placebo Comparator
NaCl 0.9% infused to match the duration of the agent for TXA127, TRV027, and APN01.
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Drug: Placebo
Fostamatinib
Experimental
An investigational oral spleen tyrosine kinase inhibitor.
Drug: Fostamatinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TXA127
Drug
TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
TXA127 (4/20/2022 Arm Closed to Accrual)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Oxygen Free Days Through Day 28.
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Day 1 to Day 28
Secondary Outcomes
Measure
Description
Time Frame
In-hospital Mortality
Number of patients who die during hospitalization
Day 1 to hospital discharge or Day 90 whichever comes first
Alive and Oxygen Free at Day 14
Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Other Outcomes
Measure
Description
Time Frame
Hypotension
Number of participants with hypotension defined by low arterial blood pressure leading to either [1] initiation or increase in vasopressor therapy, [2] administration of a fluid bolus of 500 ml or more, or [3] modification of the dose or discontinuation of the study drug.
Day 0 to Day 5 or hospital discharge whichever comes first
Eligibility Module
Eligibility Criteria
Inclusion criteria
Hospitalized for COVID-19
≥18 years of age
SARS-CoV-2 infection, documented by:
a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR
documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non- NAT tests is maintained in Appendix E. Appendix E. Non-NAT Tests Deemed with Equivalent Specificity to NAT by the Protocol Team).
Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy
Symptoms or signs of acute COVID-19, defined as one or more of the following:
cough
reported or documented body temperature of 100.4 degrees Fahrenheit or greater
shortness of breath
chest pain
infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)
Exclusion criteria
Onset of COVID-19 symptom fulfilling inclusion criterion #5 >14 days prior to randomization
Hospitalized with hypoxemia (as defined in inclusion #4) for >72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission)
Pregnancy
Breastfeeding
Prisoners
End-stage renal disease (ESRD) on dialysis
Patient undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life.
The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient
Known allergy/hypersensitivity to IMP or its excipients
The following exclusion criteria differ from the master protocol criteria:
TXA127-specific exclusion criteria(4/20/2022 Closed to Accrual):
Patient unable to participate or declines participation in the TXA127/Ang(1-7) arm.
History of sensitivity (including angioedema) or allergic reaction to medication targeting the RAAS system including study medications or other allergy in the opinion of the investigator that contraindicates participation (not applicable to fostamatinib arm)
Hemodynamic instability - defined as MAP < 65 mmHg at time of randomization confirmed on two measurements 5 minutes apart OR vasopressors at or above norepinephrine equivalent of 0.1 mcg/kg/min in prior 4 hours to maintain MAP > 65 mmHg.
Known severe renal artery stenosis.
Known significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic or mitral stenosis.
Randomized in another trial evaluating RAAS modulation in the prior 30 days
TRV027-specific exclusion criteria (4/20/2022 Closed to Accrual):
Participants on ARBs will be excluded from this study arm.
Patient unable to participate or declines participation in the TRV027 arm.
History of sensitivity (including angioedema) or allergic reaction to medication targeting the RAAS system including study medications or other allergy in the opinion of the investigator that contraindicates participation (not applicable to fostamatinib arm)
Hemodynamic instability - defined as MAP < 65 mmHg at time of randomization confirmed on two measurements 5 minutes apart OR vasopressors at or above norepinephrine equivalent of 0.1 mcg/kg/min in prior 4 hours to maintain MAP > 65 mmHg.
Known severe renal artery stenosis.
Known significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic or mitral stenosis.
Randomized in another trial evaluating RAAS modulation in the prior 30 days
Fostamatinib specific exclusion criteria:
The following exclusion criteria differ from the master protocol criteria:
1. Randomized in another trial evaluating fostamatinib in the prior 30 days
Study arm exclusion criteria measured within 24 hours prior to randomization:
AST or ALT ≥ 5 × upper limit of normal (ULN) or ALT or AST ≥ 3 × ULN and total bilirubin ≥ 2 × ULN
SBP > 160 mmHg or DBP > 100 mmHg at the time of screening and randomization
ANC < 1000/mL
Patient is anticipated to require a strong CYP3A inhibitor (Atazanavir, Certinib, Clarithromycin, Cobicistat and cobicistat-containing coformulations, Idelalisib,Indinavir, Itraconazole, Ketoconazole, Levoketoconazole, Lonafarnib, Lopinavir, Mifeprostone, Mibefradil, Nefazodone, Nelfinavir, Ombitasvir-paritaprevir-ritonavir plus dasabuvir, Posaconazole, Ribociclib Ritonavir, Saquinavir, Telithromycin, Troleandomycin, Tucatinib, Voriconazole) from randomization to 21 days post-randomization. For a full list of CYP3A4 substrates, please reference this regularly updated list: https://drug-interactions.medicine.iu.edu/MainTable.aspx.
Patient unable to participate or declines participation in the fostamatinib arm.
Collins SP, Shotwell MS, Strich JR, Gibbs KW, de Wit M, Files DC, Harkins M, Hudock K, Merck LH, Moskowitz A, Apodaca KD, Barksdale A, Safdar B, Javaheri A, Sturek JM, Schrager H, Iovine NM, Tiffany B, Douglas I, Levitt J, Ginde AA, Hager DN, Shapiro N, Duggal A, Khan A, Lanspa M, Chen P, Gentile N, Harris E, Gong M, Sellers S, Goodwin AJ, Tidswell MA, Filbin M, Desai N, Gutierrez F, Estrada V, Burgos J, Boyles T, Pano-Pardo JR, Hussen N, Rosenberg Y, Troendle J, Bernard GR, Bistran-Hall AJ, Walsh K, Casey JD, DeClercq J, Joly MM, Pulley J, Rice TW, Schildcrout JS, Wang L, Semler MW, Self WH; ACTIV-4 Host Tissue Investigators. Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2448215. doi: 10.1001/jamanetworkopen.2024.48215.
Adults hospitalized with COVID-19 were enrolled with no exclusions based on age, sex, race, ethnicity, severity of disease or preferred language. If a patient appeared to meet eligibility criteria, the site investigator approached the treating clinician to ask permission to approach the patient to confirm eligibility, discuss potential study recruitment, and proceed with informed consent. The eligibility criteria were verified and informed consent was obtained just prior to randomization.
Recruitment Details
This adaptive platform study consisted of 3 trials, each designed to assess a candidate agent as treatment for coronavirus disease 2019 (COVID-19) in hospitalized adult patients who had severe infection with acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The control group for each trial includes all participants that were eligible for that trial and received a placebo mimic for any of the three study agents (shared placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
FG001
TXA127 Shared Placebo
Periods
Title
Milestones
Reasons Not Completed
United States
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 7, 2023
Sep 3, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomly allocated in a two-step process: 1) The participant will first be randomized in an m:1 ratio to receive an active study drug or placebo, where m represents the number of study drug arms for which the participant is eligible. 2) The participant will then be randomly assigned with equal probability to one of the study drug arms. Participants will receive the corresponding study drug or matching placebo.
Results data includes data from NCT05593770.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Which study drug arm the participant enters will be known to the research sites and the participants, but assignment to active versus placebo will be blinded. The randomized assignment, concealed from the research team, will be transmitted to the site pharmacy, who will provide study medication. The participant, treating clinicians, study personnel (other than the unblinded statistician who will prepare closed DSMB interim reports), and outcome assessors will all remain blinded to group assignment until after the database is locked and blinded analysis is completed.
TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
TRV027 (4/20/2022 Arm Closed to Accrual)
Placebo
Drug
NaCl 0.9% infused to match the duration of the agent (3 hours for TXA127 and continuous 24-hour infusion for TRV027, over 30 minutes for APN01.
Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
Placebo
Fostamatinib
Drug
Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
Fostamatinib
Day 1 to Day 14
Alive and Oxygen Free at Day 28
Number of patients oxygen-free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Day 1 to Day 28
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Number of patients alive free of new invasive mechanical ventilation at day 28
Day 1 to Day 28
28-day Mortality
Number of patients who have died at Day 28
Day 28
60-day Mortality
Number of patients who have died at Day 60
Day 60
90-day Mortality
Number of patients who have died at Day 90
Day 90
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order.
Ambulatory - Not hospitalized and no limitation of activities
Ambulatory - Not hospitalized with limitation of activities or home oxygen use
Hospitalized Mild Disease - Hospitalized, no oxygen therapy
Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
Hospitalized Severe Disease -Invasive mechanical ventilation
Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
Dead
Day 14
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order.
Ambulatory - Not hospitalized and no limitation of activities
Ambulatory - Not hospitalized with limitation of activities or home oxygen use
Hospitalized Mild Disease - Hospitalized, no oxygen therapy
Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
Hospitalized Severe Disease -Invasive mechanical ventilation
Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
Dead
Day 28
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order.
Ambulatory - Not hospitalized and no limitation of activities
Ambulatory - Not hospitalized with limitation of activities or home oxygen use
Hospitalized Mild Disease - Hospitalized, no oxygen therapy
Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
Hospitalized Severe Disease -Invasive mechanical ventilation
Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
Dead
Day 60
Hospital-free Days Through Day 28
Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Day 1 to Day 28
Ventilator-free Days Through Day 28
Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Day 1 to Day 28
Respiratory Failure-free Days Through Day 28
Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1.
Day 1 to Day 28
Allergic Reaction
Number of participants with allergic reaction, including rash and angioedema
Day 0 to Day 5 or hospital discharge whichever comes first
Incident Renal Replacement Therapy During Hospitalization
Number of participants requiring renal replacement therapy during hospitalization (when possible, at participating sites)
Day 0 to Day 5 or hospital discharge whichever comes first
Chandler
Arizona
85224
United States
Cedars-Sinai Medical Center
Los Angeles
California
90048
United States
Stanford University
Stanford
California
94305
United States
University of Colorado Hospital
Aurora
Colorado
80010
United States
Denver Health Medical Center
Denver
Colorado
80204
United States
Yale University
New Haven
Connecticut
06510
United States
University of Florida
Gainesville
Florida
32610
United States
Public Health Trust of Miami-Dade County, Florida - Jackson Memorial Hospital
Miami
Florida
33136
United States
Ponce de Leon Clinical Research Site
Atlanta
Georgia
30303
United States
Emory Johns Creek
Atlanta
Georgia
30322
United States
Emory St. Joseph's Hospital
Atlanta
Georgia
30342
United States
Alexian Brothers Medical Center
Elk Grove Village
Illinois
60007
United States
AMITA Health St. Alexius Medical Center
Hoffman Estates
Illinois
60169
United States
Our Lady of the Lake Regional Medical Center
Baton Rouge
Louisiana
70808
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
Johns Hopkins Bayview Medical Center
Baltimore
Maryland
21224
United States
Johns Hopkins University
Baltimore
Maryland
21287
United States
Jadestone Clinical Research, LLC
Silver Spring
Maryland
20904
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02072
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Brigham and Women's Hospital
Boston
Massachusetts
02115
United States
Newton-Wellesley Hospital
Newton
Massachusetts
02462
United States
Baystate Health
Springfield
Massachusetts
01119
United States
Hennepin County Medical Center
Minneapolis
Minnesota
55415
United States
Washington University
St Louis
Missouri
63110
United States
University of Nebraska Medical Center
Omaha
Nebraska
68198
United States
University of New Mexico Health Sciences Center
Albuquerque
New Mexico
87106
United States
Mount Sinai Hospital
New York
New York
10029
United States
Columbia University Irving Medical Center
New York
New York
10032
United States
Montefiore Medical Center Weiler Campus
The Bronx
New York
10461
United States
Montefiore Medical Center Moses Campus
The Bronx
New York
10467
United States
University of North Carolina Medical Center
Chapel Hill
North Carolina
27514
United States
Wake Forest University Health Sciences
Winston-Salem
North Carolina
27157
United States
Cleveland Clinic Akron General
Akron
Ohio
44321
United States
University of Cincinnati
Cincinnati
Ohio
45229
United States
Cleveland Clinic Fairview Hospital
Cleveland
Ohio
44111
United States
Cleveland Clinic Foundation
Cleveland
Ohio
44195
United States
West Chester Hospital
West Chester
Ohio
45069
United States
Oregon Health & Science University
Portland
Oregon
97239
United States
Temple University Hospital
Philadelphia
Pennsylvania
19140
United States
University of Pittsburgh
Pittsburgh
Pennsylvania
15213
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37203
United States
University of Texas, Houston
Houston
Texas
77030
United States
Intermountain Medical Center
Murray
Utah
84107
United States
University of Utah Health
Salt Lake City
Utah
84108
United States
UVA Health
Charlottesville
Virginia
22908
United States
Sentara Norfolk General Hospital
Norfolk
Virginia
23507
United States
VCU Health
Richmond
Virginia
23298
United States
Harborview Medical Center/University of Washington
Seattle
Washington
98104
United States
Derived
Self WH, Shotwell MS, Gibbs KW, de Wit M, Files DC, Harkins M, Hudock KM, Merck LH, Moskowitz A, Apodaca KD, Barksdale A, Safdar B, Javaheri A, Sturek JM, Schrager H, Iovine N, Tiffany B, Douglas IS, Levitt J, Busse LW, Ginde AA, Brown SM, Hager DN, Boyle K, Duggal A, Khan A, Lanspa M, Chen P, Puskarich M, Vonderhaar D, Venkateshaiah L, Gentile N, Rosenberg Y, Troendle J, Bistran-Hall AJ, DeClercq J, Lavieri R, Joly MM, Orr M, Pulley J, Rice TW, Schildcrout JS, Semler MW, Wang L, Bernard GR, Collins SP; ACTIV-4 Host Tissue Investigators. Renin-Angiotensin System Modulation With Synthetic Angiotensin (1-7) and Angiotensin II Type 1 Receptor-Biased Ligand in Adults With COVID-19: Two Randomized Clinical Trials. JAMA. 2023 Apr 11;329(14):1170-1182. doi: 10.1001/jama.2023.3546.
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
FG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
FG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
FG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
FG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
FG000176 subjects
FG001175 subjects
FG002149 subjects
FG003147 subjects
FG004193 subjects
FG005192 subjects
COMPLETED
FG000124 subjects
FG001130 subjects
FG00299 subjects
FG003114 subjects
FG004140 subjects
FG005145 subjects
NOT COMPLETED
FG00052 subjects
FG00145 subjects
FG00250 subjects
FG00333 subjects
FG00453 subjects
FG00547 subjects
Type
Comment
Reasons
Death
FG00029 subjects
FG00132 subjects
FG00234 subjects
FG00325 subjects
FG00426 subjects
FG00523 subjects
Lost to Follow-up
FG00015 subjects
FG00110 subjects
FG00213 subjects
FG0035 subjects
FG004
Withdrawal by Subject
FG0008 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
Spain
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00410 subjects
FG0059 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Brazil
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Germany
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Italy
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
South Africa
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0053 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
BG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
BG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
BG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
BG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
BG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000176
BG001175
BG002149
BG003147
BG004207
BG005206
BG0061060
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
Count of Participants
Participants
Title
Denominators
Categories
All Countries
ParticipantsBG000176
ParticipantsBG001175
ParticipantsBG002149
ParticipantsBG003
Sex: Female, Male
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
Count of Participants
Participants
Title
Denominators
Categories
All Countries
ParticipantsBG000176
ParticipantsBG001175
ParticipantsBG002
Ethnicity (NIH/OMB)
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
Count of Participants
Participants
Title
Denominators
Categories
All Countries
ParticipantsBG000176
ParticipantsBG001175
ParticipantsBG002
Race (NIH/OMB)
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
Count of Participants
Participants
Title
Denominators
Categories
All Countries
ParticipantsBG000176
ParticipantsBG001175
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
ParticipantsBG000176
ParticipantsBG001175
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Oxygen Free Days Through Day 28.
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Mean
Standard Deviation
Days
Day 1 to Day 28
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000153
OG001155
OG002135
OG003
Title
Denominators
Categories
All Countries
ParticipantsOG000153
ParticipantsOG001155
ParticipantsOG002135
ParticipantsOG003
Secondary
In-hospital Mortality
Number of patients who die during hospitalization
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 1 to hospital discharge or Day 90 whichever comes first
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
Secondary
Alive and Oxygen Free at Day 14
Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 1 to Day 14
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Secondary
Alive and Oxygen Free at Day 28
Number of patients oxygen-free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Secondary
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Number of patients alive free of new invasive mechanical ventilation at day 28
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
Secondary
28-day Mortality
Number of patients who have died at Day 28
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 28
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
Secondary
60-day Mortality
Number of patients who have died at Day 60
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 60
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
Secondary
90-day Mortality
Number of patients who have died at Day 90
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 90
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
Secondary
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order.
Ambulatory - Not hospitalized and no limitation of activities
Ambulatory - Not hospitalized with limitation of activities or home oxygen use
Hospitalized Mild Disease - Hospitalized, no oxygen therapy
Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
Hospitalized Severe Disease -Invasive mechanical ventilation
Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
Dead
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 14
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
Secondary
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order.
Ambulatory - Not hospitalized and no limitation of activities
Ambulatory - Not hospitalized with limitation of activities or home oxygen use
Hospitalized Mild Disease - Hospitalized, no oxygen therapy
Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
Hospitalized Severe Disease -Invasive mechanical ventilation
Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
Dead
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 28
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
Secondary
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order.
Ambulatory - Not hospitalized and no limitation of activities
Ambulatory - Not hospitalized with limitation of activities or home oxygen use
Hospitalized Mild Disease - Hospitalized, no oxygen therapy
Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
Hospitalized Severe Disease -Invasive mechanical ventilation
Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
Dead
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 60
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
Secondary
Hospital-free Days Through Day 28
Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Mean
Standard Deviation
Days
Day 1 to Day 28
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
Secondary
Ventilator-free Days Through Day 28
Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Mean
Standard Deviation
Days
Day 1 to Day 28
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
Secondary
Respiratory Failure-free Days Through Day 28
Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1.
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Mean
Standard Deviation
Days
Day 1 to Day 28
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Other Pre-specified
Hypotension
Number of participants with hypotension defined by low arterial blood pressure leading to either [1] initiation or increase in vasopressor therapy, [2] administration of a fluid bolus of 500 ml or more, or [3] modification of the dose or discontinuation of the study drug.
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 0 to Day 5 or hospital discharge whichever comes first
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Other Pre-specified
Allergic Reaction
Number of participants with allergic reaction, including rash and angioedema
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 0 to Day 5 or hospital discharge whichever comes first
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
Other Pre-specified
Incident Renal Replacement Therapy During Hospitalization
Number of participants requiring renal replacement therapy during hospitalization (when possible, at participating sites)
Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Posted
Count of Participants
Participants
Day 0 to Day 5 or hospital discharge whichever comes first
ID
Title
Description
OG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
OG001
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Time Frame
90 Days
Description
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
29
176
8
176
29
176
EG001
TXA127 Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
32
175
4
175
5
175
EG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
34
149
6
149
3
149
EG003
TRV027 Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
25
147
2
147
6
147
EG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
27
193
16
193
18
193
EG005
Fostamatinib Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
26
192
44
192
25
192
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG0030 events0 affected147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0021 events1 affected149 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Asthenia
General disorders
MedDRA Version 27.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Infection
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Lower respiratory tract infection bacteria
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Vulval cellulitis
Infections and infestations
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Haematoma muscle
Musculoskeletal and connective tissue disorders
MedDRA Version 27.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected175 at risk
EG0020 events0 affected149 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OG004-1± NAUnable to provide standard deviation only 1 participant affected
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0051
Title
Measurements
OG0050± NAUnable to provide standard deviation only 1 participant affected
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
Title
Measurements
OG00414± NAUnable to provide standard deviation only 1 participant affected
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG00425.5± 3.5
OG00526.5± 0.7
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000167
OG001172
OG002145
OG003144
OG004197
OG005197
Title
Denominators
Categories
All Countries
ParticipantsOG000167
ParticipantsOG001172
ParticipantsOG002145
ParticipantsOG003144
ParticipantsOG004197
ParticipantsOG005197
Title
Measurements
OG00023
OG00124
OG00231
OG003
United States
ParticipantsOG000167
ParticipantsOG001172
ParticipantsOG002145
ParticipantsOG003144
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000158
OG001164
OG002138
OG003137
OG004189
OG005191
Title
Denominators
Categories
All Countries
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
ParticipantsOG004189
ParticipantsOG005191
Title
Measurements
OG00060
OG00186
OG00248
OG003
United States
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000155
OG001158
OG002135
OG003134
OG004187
OG005189
Title
Denominators
Categories
All Countries
ParticipantsOG000155
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
ParticipantsOG004187
ParticipantsOG005189
Title
Measurements
OG00078
OG00187
OG00260
OG003
United States
ParticipantsOG000155
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000155
OG001160
OG002136
OG003136
OG004186
OG005190
Title
Denominators
Categories
All Countries
ParticipantsOG000155
ParticipantsOG001160
ParticipantsOG002136
ParticipantsOG003136
ParticipantsOG004186
ParticipantsOG005190
Title
Measurements
OG000124
OG001128
OG00299
OG003
United States
ParticipantsOG000155
ParticipantsOG001160
ParticipantsOG002136
ParticipantsOG003136
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000163
OG001166
OG002141
OG003140
OG004195
OG005197
Title
Denominators
Categories
All Countries
ParticipantsOG000163
ParticipantsOG001166
ParticipantsOG002141
ParticipantsOG003140
ParticipantsOG004195
ParticipantsOG005197
Title
Measurements
OG00022
OG00122
OG00229
OG003
United States
ParticipantsOG000163
ParticipantsOG001166
ParticipantsOG002141
ParticipantsOG003140
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000161
OG001166
OG002139
OG003140
OG004195
OG005195
Title
Denominators
Categories
All Countries
ParticipantsOG000161
ParticipantsOG001166
ParticipantsOG002139
ParticipantsOG003140
ParticipantsOG004195
ParticipantsOG005195
Title
Measurements
OG00026
OG00129
OG00233
OG003
United States
ParticipantsOG000161
ParticipantsOG001166
ParticipantsOG002139
ParticipantsOG003140
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000158
OG001161
OG002135
OG003138
OG004186
OG005186
Title
Denominators
Categories
All Countries
ParticipantsOG000158
ParticipantsOG001161
ParticipantsOG002135
ParticipantsOG003138
ParticipantsOG004186
ParticipantsOG005186
Title
Measurements
OG00028
OG00131
OG00234
OG003
United States
ParticipantsOG000158
ParticipantsOG001161
ParticipantsOG002135
ParticipantsOG003138
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000158
OG001164
OG002138
OG003137
OG004188
OG005191
Title
Denominators
Categories
Alll Countries Score=1
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
ParticipantsOG004188
ParticipantsOG005191
Title
Measurements
OG00037
OG00157
OG00231
OG003
Alll Countries Score=2
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
Alll Countries Score=3
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
Alll Countries Score=4
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
Alll Countries Score=5
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
Alll Countries Score=6
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
Alll Countries Score =7
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
Alll Countries Score=8
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
United States Score=1
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
United States Score=2
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
United States Score=3
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
United States Score=4
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
United States Score=5
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
United States Score=6
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
United States Score=7
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
United States Score=8
ParticipantsOG000158
ParticipantsOG001164
ParticipantsOG002138
ParticipantsOG003137
Spain Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy=Score1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000154
OG001158
OG002135
OG003134
OG004182
OG005189
Title
Denominators
Categories
All Countries Score=1
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
ParticipantsOG004182
ParticipantsOG005189
Title
Measurements
OG00058
OG00162
OG00248
OG003
All Countries Score=2
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
All Countries Score=3
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
All Countries Score=4
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
All Countries Score=5
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
All Countries Score=6
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
All Countries Score=7
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
All Countries Score=8
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
United States Score=1
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
United States Score=2
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
United States Score=3
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
United States Score=4
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
United States Score=5
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
United States Score=6
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
United States Score=7
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
United States Score=8
ParticipantsOG000154
ParticipantsOG001158
ParticipantsOG002135
ParticipantsOG003134
Spain Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000128
OG001140
OG002108
OG003115
OG004161
OG005167
Title
Denominators
Categories
All Countries Score=1
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
ParticipantsOG004161
ParticipantsOG005167
Title
Measurements
OG00037
OG00157
OG00231
OG003
All Countries Score=2
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
All Countries Score=3
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
All Countries Score=4
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
All Countries Score=5
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
All Countries Score=6
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
All Countries Score=7
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
All Countries Score=8
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
United States Score=1
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
United States Score=2
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
United States Score=3
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
United States Score=4
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
United States Score=5
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
United States Score=6
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
United States Score=7
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
United States Score=8
ParticipantsOG000128
ParticipantsOG001140
ParticipantsOG002108
ParticipantsOG003115
Spain Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Spain Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa Score=8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000154
OG001160
OG002136
OG003136
OG004184
OG005190
Title
Denominators
Categories
All Countries
ParticipantsOG000154
ParticipantsOG001160
ParticipantsOG002136
ParticipantsOG003136
ParticipantsOG004184
ParticipantsOG005190
Title
Measurements
OG0009.0± 10.9
OG00111.3± 11.5
OG0028.1± 10.8
OG003
United States
ParticipantsOG000154
ParticipantsOG001160
ParticipantsOG002136
ParticipantsOG003136
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000150
OG001159
OG002135
OG003135
OG004177
OG005186
Title
Denominators
Categories
All Countries
ParticipantsOG000150
ParticipantsOG001159
ParticipantsOG002135
ParticipantsOG003135
ParticipantsOG004177
ParticipantsOG005186
Title
Measurements
OG0009.0± 10.9
OG00111.3± 11.5
OG0028.1± 10.8
OG003
United States
ParticipantsOG000150
ParticipantsOG001159
ParticipantsOG002135
ParticipantsOG003135
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000150
OG001160
OG002135
OG003136
OG004177
OG005186
Title
Denominators
Categories
All Countries
ParticipantsOG000150
ParticipantsOG001160
ParticipantsOG002135
ParticipantsOG003136
ParticipantsOG004177
ParticipantsOG005186
Title
Measurements
OG0009.0± 10.9
OG00111.3± 11.5
OG0028.1± 10.8
OG003
United States
ParticipantsOG000150
ParticipantsOG001160
ParticipantsOG002135
ParticipantsOG003136
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000170
OG001173
OG002145
OG003145
OG004199
OG005201
Title
Denominators
Categories
All Countries
ParticipantsOG000170
ParticipantsOG001173
ParticipantsOG002145
ParticipantsOG003145
ParticipantsOG004199
ParticipantsOG005201
Title
Measurements
OG00031
OG00131
OG00232
OG003
United States
ParticipantsOG000170
ParticipantsOG001173
ParticipantsOG002145
ParticipantsOG003145
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000170
OG001173
OG002145
OG003145
OG004199
OG005201
Title
Denominators
Categories
All Countries
ParticipantsOG000170
ParticipantsOG001173
ParticipantsOG002145
ParticipantsOG003145
ParticipantsOG004199
ParticipantsOG005201
Title
Measurements
OG0003
OG0014
OG0020
OG003
United States
ParticipantsOG000170
ParticipantsOG001173
ParticipantsOG002145
ParticipantsOG003145
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
OG003
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
OG004
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
OG005
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Units
Counts
Participants
OG000170
OG001173
OG002145
OG003145
OG004199
OG005201
Title
Denominators
Categories
All Countries
ParticipantsOG000170
ParticipantsOG001173
ParticipantsOG002145
ParticipantsOG003145
ParticipantsOG004199
ParticipantsOG005201
Title
Measurements
OG00011
OG00112
OG0029
OG003
United States
ParticipantsOG000170
ParticipantsOG001173
ParticipantsOG002145
ParticipantsOG003145
Spain
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Brazil
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Germany
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Italy
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
South Africa
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0052 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0044 events4 affected193 at risk
EG0052 events2 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0042 events2 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0042 events2 affected193 at risk
EG0055 events5 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
1 events
1 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0055 events4 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
1 events
1 affected
147 at risk
EG0041 events1 affected193 at risk
EG0052 events2 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0052 events2 affected192 at risk
0 events
0 affected
147 at risk
EG0042 events2 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0053 events3 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0042 events1 affected193 at risk
EG0053 events2 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0052 events2 affected192 at risk
0 events
0 affected
193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0042 events2 affected193 at risk
EG0052 events2 affected192 at risk
0 events
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
1 events
1 affected
147 at risk
EG0041 events1 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0046 events6 affected193 at risk
EG0052 events2 affected192 at risk
2 events
1 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
2 events
2 affected
147 at risk
EG0040 events0 affected193 at risk
EG0054 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0052 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
1 events
1 affected
147 at risk
EG0042 events2 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0052 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0042 events2 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
1 events
1 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0051 events1 affected192 at risk
0 events
0 affected
147 at risk
EG0040 events0 affected193 at risk
EG0050 events0 affected192 at risk
0 events
0 affected
147 at risk
EG0041 events1 affected193 at risk
EG0052 events2 affected192 at risk
88
BG00581
BG006634
119
BG005125
BG006426
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG000121
BG001128
BG002109
BG003107
BG00484
BG00578
BG006627
>=65 years
BG00055
BG00147
BG00240
BG00340
BG004109
BG005114
BG006405
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0042
BG0052
BG0064
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0048
BG0057
BG00615
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
BG0062
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
BG0062
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0041
BG0052
BG0063
104
BG005111
BG006593
69
BG00497
BG00589
BG006455
Male
BG000106
BG00199
BG00295
BG00378
BG00496
BG005103
BG006577
0
BG0043
BG0054
BG0067
Male
BG0000
BG0010
BG0020
BG0030
BG0047
BG0055
BG00612
0
BG0041
BG0050
BG0061
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0040
BG0050
BG0060
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
1
BG0062
Male
BG0000
BG0010
BG0040
BG0050
BG0060
0
BG0041
BG0051
BG0062
Male
BG0000
BG0010
BG0020
BG0030
BG0041
BG0052
BG0063
174
BG005165
BG006848
6
BG00511
BG00653
23
BG00421
BG00525
BG006148
Not Hispanic or Latino
BG000140
BG001140
BG002113
BG003116
BG004170
BG005161
BG006840
Unknown or Not Reported
BG0008
BG0019
BG00211
BG0038
BG0042
BG0056
BG00644
0
BG0045
BG0055
BG00610
Not Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0044
BG0054
BG0068
0
Not Hispanic or Latino
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0030
BG0041
BG0050
BG0061
0
BG0040
BG0050
BG0060
Not Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0040
BG0050
BG0060
Not Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
0
BG0040
BG0050
BG0060
Not Hispanic or Latino
BG00000
BG0010
BG0020
BG0030
BG0042
BG0053
BG0065
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
6
BG0056
BG00625
3
BG0050
BG0064
24
BG00523
BG006153
149
BG005160
BG006736
1
BG0050
BG0062
22
BG00513
BG006125
1
BG0042
BG0054
BG00615
Asian
BG0004
BG0014
BG0022
BG0033
BG0046
BG0056
BG00625
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0030
BG0043
BG0050
BG0064
Black or African American
BG00029
BG00130
BG00225
BG00322
BG00422
BG00521
BG006149
White
BG000115
BG001114
BG002101
BG00397
BG004139
BG005148
BG006714
More than one race
BG0001
BG0010
BG0020
BG0030
BG0041
BG0050
BG0062
Unknown or Not Reported
BG00022
BG00125
BG00219
BG00324
BG00420
BG00513
BG006123
0
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
White
BG0000
BG0010
BG0020
BG0030
BG0049
BG0059
BG00618
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
0
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
White
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
0
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
White
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
White
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
BG0062
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0042
BG0052
BG0064
White
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG00410
BG0059
BG00619
0
BG0041
BG0050
BG0061
0
BG0040
BG0051
BG0061
0
BG0041
BG0051
BG0062
0
BG0042
BG0053
BG0065
10.5
± 11.5
OG00412.9± 12.5
OG00513.9± 12
20
OG00423
OG00516
ParticipantsOG004184
ParticipantsOG005185
Title
Measurements
OG00023
OG00124
OG00231
OG00320
OG00422
OG00515
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
66
OG004113
OG005113
ParticipantsOG004176
ParticipantsOG005179
Title
Measurements
OG00060
OG00186
OG00248
OG00366
OG004103
OG005105
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0048
OG0056
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0052
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
69
OG004106
OG005123
ParticipantsOG004174
ParticipantsOG005177
Title
Measurements
OG00078
OG00187
OG00260
OG00369
OG00495
OG005114
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0048
OG0057
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0052
109
OG004160
OG005171
ParticipantsOG004173
ParticipantsOG005178
Title
Measurements
OG000124
OG001128
OG00299
OG003109
OG004148
OG005160
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0049
OG0058
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0052
18
OG00422
OG00516
ParticipantsOG004182
ParticipantsOG005185
Title
Measurements
OG00022
OG00122
OG00229
OG00318
OG00421
OG00515
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
23
OG00425
OG00522
ParticipantsOG004182
ParticipantsOG005183
Title
Measurements
OG00026
OG00129
OG00233
OG00323
OG00424
OG00520
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
25
OG00427
OG00526
ParticipantsOG004174
ParticipantsOG005174
Title
Measurements
OG00028
OG00131
OG00234
OG00325
OG00426
OG00523
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
45
OG00453
OG00575
ParticipantsOG004188
ParticipantsOG005191
Title
Measurements
OG00061
OG00153
OG00250
OG00348
OG00479
OG00577
ParticipantsOG004188
ParticipantsOG005191
Title
Measurements
OG0005
OG0015
OG0022
OG0033
OG00415
OG0054
ParticipantsOG004188
ParticipantsOG005191
Title
Measurements
OG00019
OG0017
OG0028
OG0036
OG00420
OG00514
ParticipantsOG004188
ParticipantsOG005191
Title
Measurements
OG0006
OG0017
OG0027
OG0036
OG0043
OG0052
ParticipantsOG004188
ParticipantsOG005191
Title
Measurements
OG0006
OG0016
OG0025
OG0034
OG0044
OG0052
ParticipantsOG004188
ParticipantsOG005191
Title
Measurements
OG00012
OG00114
OG00214
OG00314
OG0043
OG0057
ParticipantsOG004188
ParticipantsOG005191
Title
Measurements
OG00012
OG00113
OG00221
OG00311
OG00411
OG00510
ParticipantsOG004175
ParticipantsOG005179
Title
Measurements
OG00037
OG00157
OG00231
OG00345
OG00445
OG00568
ParticipantsOG004175
ParticipantsOG005179
Title
Measurements
OG00061
OG00155
OG00250
OG00348
OG00476
OG00559
ParticipantsOG004175
ParticipantsOG005179
Title
Measurements
OG0005
OG0015
OG0022
OG0033
OG00415
OG0053
ParticipantsOG004175
ParticipantsOG005179
Title
Measurements
OG00019
OG0017
OG0028
OG0036
OG00419
OG00511
ParticipantsOG004175
ParticipantsOG005179
Title
Measurements
OG0006
OG0017
OG0027
OG0036
OG0043
OG0052
ParticipantsOG004175
ParticipantsOG005179
Title
Measurements
OG0006
OG0016
OG0028
OG0034
OG0044
OG0052
ParticipantsOG004175
ParticipantsOG005179
Title
Measurements
OG00012
OG00114
OG00214
OG00314
OG0041
OG0057
ParticipantsOG004175
ParticipantsOG005179
Title
Measurements
OG00012
OG00113
OG00221
OG00311
OG00410
OG0059
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0046
OG0055
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0043
OG0051
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0051
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
47
OG00463
OG00574
ParticipantsOG004182
ParticipantsOG005189
Title
Measurements
OG00053
OG00158
OG00244
OG00353
OG00476
OG00588
ParticipantsOG004182
ParticipantsOG005189
Title
Measurements
OG0004
OG0012
OG0020
OG0032
OG0046
OG0053
ParticipantsOG004182
ParticipantsOG005189
Title
Measurements
OG0007
OG0011
OG0023
OG0032
OG0048
OG0053
ParticipantsOG004182
ParticipantsOG005189
Title
Measurements
OG0001
OG0013
OG0023
OG0033
OG0041
OG0052
ParticipantsOG004182
ParticipantsOG005189
Title
Measurements
OG0004
OG0015
OG0023
OG0034
OG0041
OG0051
ParticipantsOG004182
ParticipantsOG005189
Title
Measurements
OG0005
OG0015
OG0025
OG0035
OG0043
OG0052
ParticipantsOG004182
ParticipantsOG005189
Title
Measurements
OG00022
OG00122
OG00229
OG00318
OG00422
OG00516
ParticipantsOG004169
ParticipantsOG005177
Title
Measurements
OG00058
OG00162
OG00248
OG00347
OG00456
OG00567
ParticipantsOG004169
ParticipantsOG005177
Title
Measurements
OG00053
OG00158
OG00244
OG00353
OG00475
OG00585
ParticipantsOG004169
ParticipantsOG005177
Title
Measurements
OG0004
OG0012
OG0020
OG0032
OG0045
OG0052
ParticipantsOG004169
ParticipantsOG005177
Title
Measurements
OG0007
OG0012
OG0023
OG0032
OG0047
OG0053
ParticipantsOG004169
ParticipantsOG005177
Title
Measurements
OG0001
OG0013
OG0023
OG0033
OG0041
OG0052
ParticipantsOG004169
ParticipantsOG005177
Title
Measurements
OG0004
OG0015
OG0023
OG0034
OG0041
OG0051
ParticipantsOG004169
ParticipantsOG005177
Title
Measurements
OG0005
OG0015
OG0025
OG0035
OG0043
OG0052
ParticipantsOG004169
ParticipantsOG005177
Title
Measurements
OG00022
OG00122
OG00229
OG00318
OG00421
OG00515
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0047
OG0056
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0051
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
45
OG00453
OG00575
ParticipantsOG004161
ParticipantsOG005167
Title
Measurements
OG00061
OG00155
OG00250
OG00348
OG00479
OG00577
ParticipantsOG004161
ParticipantsOG005167
Title
Measurements
OG0005
OG0015
OG0022
OG0033
OG00415
OG0054
ParticipantsOG004161
ParticipantsOG005167
Title
Measurements
OG00019
OG0017
OG0028
OG0036
OG00420
OG00514
ParticipantsOG004161
ParticipantsOG005167
Title
Measurements
OG0006
OG0017
OG0027
OG0036
OG0043
OG0052
ParticipantsOG004161
ParticipantsOG005167
Title
Measurements
OG0006
OG0019
OG0025
OG0034
OG0044
OG0052
ParticipantsOG004161
ParticipantsOG005167
Title
Measurements
OG00012
OG00114
OG00214
OG00314
OG0043
OG0057
ParticipantsOG004161
ParticipantsOG005167
Title
Measurements
OG00012
OG00113
OG00221
OG00321
OG00411
OG00510
ParticipantsOG004150
ParticipantsOG005155
Title
Measurements
OG00037
OG00157
OG00231
OG00345
OG00445
OG00569
ParticipantsOG004150
ParticipantsOG005155
Title
Measurements
OG00061
OG00155
OG00250
OG00348
OG00476
OG00576
ParticipantsOG004150
ParticipantsOG005155
Title
Measurements
OG0005
OG0015
OG0022
OG0033
OG00415
OG0053
ParticipantsOG004150
ParticipantsOG005155
Title
Measurements
OG00019
OG0017
OG0028
OG0036
OG00419
OG00511
ParticipantsOG004150
ParticipantsOG005155
Title
Measurements
OG0006
OG0017
OG0027
OG0036
OG0043
OG0052
ParticipantsOG004150
ParticipantsOG005155
Title
Measurements
OG0006
OG0016
OG0025
OG0034
OG0044
OG0052
ParticipantsOG004150
ParticipantsOG005155
Title
Measurements
OG00012
OG00114
OG00214
OG00314
OG0043
OG0057
ParticipantsOG004150
ParticipantsOG005155
Title
Measurements
OG00012
OG00113
OG00221
OG00311
OG00410
OG0059
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0045
OG0056
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0051
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
8
ParticipantsOG0059
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0051
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
10.5
± 11.5
OG00413.4± 12.4
OG00514.2± 12.1
ParticipantsOG004171
ParticipantsOG005178
Title
Measurements
OG0009.0± 10.9
OG00111.3± 11.5
OG0028.1± 10.8
OG00310.5± 11.5
OG00412.9± 12.5
OG00513.9± 12
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG00421.3± 8.2
OG00519.5± 12.5
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG004-1± NAUnable to provide standard deviation only 1 participant affected
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0050± NAUnable to provide standard deviation only 1 participant affected
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG00414± NAUnable to provide standard deviation only 1 participant affected
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG00425.5± 3.5
OG00526.5± 0.7
10.5
± 11.5
OG00412.9± 12.5
OG00513.9± 12
ParticipantsOG004164
ParticipantsOG005174
Title
Measurements
OG0009.0± 10.9
OG00111.3± 11.5
OG0028.1± 10.8
OG00310.5± 11.5
OG00412.9± 12.5
OG00513.9± 12
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG00421.3± 8.2
OG00519.5± 12.5
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG004-1± NAUnable to provide standard deviation only 1 participant affected
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0050± NAUnable to provide standard deviation only 1 participant affected
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG00414± NAUnable to provide standard deviation only 1 participant affected
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG00425.5± 3.5
OG00526.5± 0.7
10.5
± 11.5
OG00413.4± 12.4
OG00514.2± 12.1
ParticipantsOG004164
ParticipantsOG005174
Title
Measurements
OG0009.0± 10.9
OG00111.3± 11.5
OG0028.1± 10.8
OG00310.5± 11.5
OG00412.9± 12.5
OG00513.9± 12
Participants
OG004
9
ParticipantsOG0059
Title
Measurements
OG00421.3± 8.2
OG00519.5± 12.5
Participants
OG004
177
ParticipantsOG0050
Title
Measurements
OG004-1± NAUnable to provide standard deviation only 1 participant affected
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0050± NAUnable to provide standard deviation only 1 participant affected
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG00414± NAUnable to provide standard deviation only 1 participant affected