A Dose Finding, Efficacy and Safety Study of Ensovibep (M... | NCT04828161 | Trialant
NCT04828161
Sponsor
Novartis Pharmaceuticals
Status
Terminated
Last Update Posted
Jan 27, 2026Actual
Enrollment
407Actual
Phase
Phase 2Phase 3
Conditions
COVID-19
Interventions
ensovibep
Placebo
Countries
United States
Hungary
India
Netherlands
South Africa
Protocol Section
Identification Module
NCT ID
NCT04828161
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MP0420-CP302
Secondary IDs
ID
Type
Description
Link
2021-000890-10
EudraCT Number
CSKO136A12201J
Other Identifier
Novartis Pharmaceuticals
Brief Title
A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 - The "EMPATHY" Trial
Acronym
EMPATHY
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Phase 2 completed as planned. Due to the evolving landscape of treatments for COVID-19, the placebo-controlled Phase 3 design will not proceed. No patients were actively participating at the time of termination.
Expanded Access Info
No
Start Date
May 10, 2021Actual
Primary Completion Date
Nov 18, 2021Actual
Completion Date
Jan 27, 2022Actual
First Submitted Date
Mar 24, 2021
First Submission Date that Met QC Criteria
Mar 30, 2021
First Posted Date
Apr 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Nov 14, 2022
Results First Submitted that Met QC Criteria
Dec 21, 2022
Results First Posted Date
Jan 18, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 28, 2022
Certification/Extension First Submitted that Passed QC Review
Dec 21, 2022
Certification/Extension First Posted Date
Jan 18, 2023Actual
Last Update Submitted Date
Jan 7, 2026
Last Update Posted Date
Jan 27, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Molecular Partners AG
INDUSTRY
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 purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients.
Detailed Description
Primary objectives:
Part A: The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8.
Part B: The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29.
Secondary objectives:
Part A: The secondary objectives of this Part are:
To assess the effect of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29
To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms through Day 29
To evaluate safety and tolerability of ensovibep
To characterize the pharmacokinetics (PK) of ensovibep
Part B: The secondary objectives of this Part are:
To assess the effect of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8
To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms up to Day 29
To evaluate the immunogenicity of ensovibep during the study and its clinical relevance (PK, efficacy and safety)
To evaluate safety and tolerability of ensovibep
Although Amendment 2 was created, modifications for this amendment are not reflected as it was never approved or implemented in the US. The study was conducted under Global Protocol Amendment 1, the last active version of the protocol.
Phase 2 / Part A, ensovibep active treatment arm 1
Experimental
Phase 2 / Part A: ensovibep active treatment arm 1
Drug: ensovibep
Phase 2 / Part A, ensovibep active treatment arm 2
Experimental
Phase 2 / Part A: ensovibep active treatment arm 2
Drug: ensovibep
Phase 2 / Part A, ensovibep active treatment arm 3
Experimental
Phase 2 / Part A: ensovibep active treatment arm 3
Drug: ensovibep
Phase 2 / Part A, Placebo
Placebo Comparator
Phase 2 / Part A: Placebo
Drug: Placebo
Phase 3/ Part B, ensovibep active treatment arm 4
Experimental
Phase 3/ Part B: ensovibep active treatment. Part B was not initiated.
Drug: ensovibep
Phase 3/ Part B, Placebo arm
Placebo Comparator
Phase 3/ Part B: Placebo. Part B was not initiated.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ensovibep
Drug
IV on day 1 only.
Phase 2 / Part A, ensovibep active treatment arm 1
Phase 2 / Part A, ensovibep active treatment arm 2
Phase 2 / Part A, ensovibep active treatment arm 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8
The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used. Time-weighted change from baseline was used as viral loads were measured at multiple time points.
Baseline (Day 1) and Days 3, 5 and 8
Part B: Percentage of Participants With Hospitalizations and/or Emergency Room (ER) Visits Related to COVID-19 or Death From Any Cause
Percentage of participants experiencing hospitalizations [>= 24 hour (h) of acute care] and/or ER visits related to COVID-19 or death from any cause up to Day 29.
Up to Day 29
Secondary Outcomes
Measure
Description
Time Frame
Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause
Percentage of participants experiencing hospitalizations (>= 24 h of acute care) and/or ER visits related to COVID-19 or death from any cause up to Day 29 were presented along with relative risk to placebo.
Up to Day 29
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Part A Inclusion Criteria:
Men and women ≥ 18 years of age on the day of inclusion (no upper limit).
Presence of two or more of the following COVID-19 symptoms with an onset within 7 days of dosing: Feeling hot or feverish, cough, sore throat, low energy, or tiredness, headache, muscle or body aches, chills or shivering, and shortness of breath.
Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).
Understand and agree to comply with the planned study procedures.
The patient or legally authorized representative give signed informed consent.
Part A Exclusion Criteria:
Requiring hospitalization at time of screening, or at time of study drug administration.
Oxygen saturation (SpO2) ≤ 93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300, respiratory rate ≥ 30 per minute, and heart rate ≥ 125 per minute. In India, patients with a respiratory rate ≥ 24 per minute or with an oxygen saturation ≤ 93% on room air (SpO2) are not eligible.
Known allergies to any of the components used in the formulation of the ensovibep or placebo.
Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking intervention.
Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing.
Prior or concurrent use of any medication for treatment of COVID-19, including antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and nonsteroidal anti-inflammatory drugs [NSAIDs]) are permitted. Prior vaccination for COVID-19 is permitted.
Are concurrently enrolled or were enrolled within the last 30 days or within 5 half-lives (whichever is longer) in any other type of medical research judged not to be scientifically or medically compatible with this study.
Are pregnant or breast feeding.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception at the time of dosing and for 11 weeks after dosing of study drug. Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (i.e., calendar, ovulation, symptothermal, and postovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had bilateral surgical oophorectomy [with or without hysterectomy], total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient.
Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).
Patients in the USA who are at high risk of progression to severe COVID-19 illness or hospitalization must not be enrolled in Part A of this study as a placebo-controlled study may not be appropriate in this patient population due to the availability of anti-viral mAbs under EUA in the USA.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Jasper Summit Research, LLC
Jasper
Alabama
35501
United States
Benchmark Southern California
References Module
Citations
Not provided
See Also Links
Label
URL
A Plain Language Trial Summary is available on www.novctrd.com
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The Part A of the study consisted of a screening period (up to 3 days) followed by study treatment on Day 1. Participants were randomized in 1:1:1:1 ratio, stratified by risk for COVID-19 disease progression, to receive 1 of 4 study treatments (Ensovibep 600 mg or Ensovibep 225 mg or Ensovibep 75 mg or Placebo). A total of 407 participants were randomized in the study, of which 400 were treated.
Recruitment Details
This study consisted of 2 parts, Part A and Part B. The Part A was Phase II proof of efficacy study conducted in ambulatory adult participants with symptomatic coronavirus disease 2019 (COVID-19) at 45 centers across 5 countries (Hungary, India, Netherlands, South Africa, and USA) between 10 May 2021 and 27 Jan 2022. The Part B was to be a Phase III confirmatory study. Only Part A analysis is reported since Part B of the study was not initiated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ensovibep 600 mg
Participants received single intravenous (IV) infusion of ensovibep 600 milligram (mg) on Day 1.
FG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
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
Oct 19, 2021
Nov 1, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Poland
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
Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
4 Arms under Phase 2 and 2 Arms under Phase 3
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Double Blind: two or more parties are unaware of the intervention assignment
Masked roles are: Subject, Caregiver, Investigator or Outcomes Assessor.
Sustained clinical recovery was defined as follows;
All symptoms from the modified Food and Drug Administration (FDA) COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and
All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.
Up to Day 29
Part A: Observed Maximum Serum Concentration (Cmax) of Total and Free Ensovibep
Blood samples were collected to determine the Cmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total and Free Ensovibep
Blood samples were collected to determine the AUClast of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Part A: Area Under the Concentration-Time Curve From Time Zero to 48 Hours (AUC 0-48h) of Total and Free Ensovibep
Blood samples were collected to determine the AUC 0-48h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Day 3
Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep
Blood samples were collected to determine the AUC 0-168h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3 and 8
Part A: Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC 0-336h) of Total and Free Ensovibep
Blood samples were collected to determine the AUC 0-336h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8 and 15
Part A: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinfinity) of Total and Free Ensovibep
Blood samples were collected to determine the AUCinfinity of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Part A: Time to Reach the Maximum Concentration (Tmax) of Total and Free Ensovibep
Blood samples were collected to determine the Tmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep
Blood samples were collected to determine the CL of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Part A: Terminal Elimination Rate Constant (Lambda z) of Total and Free Ensovibep
Blood samples were collected to determine the lambda z of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Part A: Terminal Elimination Half-Life (T1/2) of Total and Free Ensovibep
Blood samples were collected to determine the T1/2 of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep
Blood samples were collected to determine the Vz of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Part B: Change From Baseline in Log10 SARS-CoV-2 Viral Load Through Day 8
The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used.
Baseline (Day 1) and Days 3, 5 and 8
Part B: Time to Sustained Clinical Recovery
Sustained clinical recovery was defined as follows;
All symptoms from the modified FDA COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and
All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.
Up to Day 29
Part B: Percentage of Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Response to Ensovibep
Treatment-emergent ADA is defined as any participant with a
2-fold (1 dilution) increase in titer than the minimum required dilution if no ADAs were detected at baseline (treatment-induced ADA); or,
4-fold (2 dilutions) increase in titer compared with baseline if ADAs were detected at baseline (treatment-boosted ADA).
Pre-dose on Day 1 and Days 15, 29, 61 and 91 postdose of Ensovibep
Colton
California
92324
United States
Ascada Research
Fullerton
California
92835
United States
Pacific Neuropsychiatric Specialists
Mission Viejo
California
92691
United States
Providence Family Medical Center
Redondo Beach
California
90277
United States
Future Innovative Treatments
Colorado Springs
Colorado
80907
United States
Boward Infectious Disease and Primary Care
Margate
Florida
33063
United States
Suncoast Research Group, LLC
Miami
Florida
33135
United States
Life Spring Research Foundation
Miami
Florida
33155
United States
Bio-Medical Research, LLC
Miami
Florida
33184
United States
Panax Clinical Research, LLC
Miami Lakes
Florida
33014
United States
AdventHealth Tampa
Tampa
Florida
33613
United States
Palm Beach Research Center
West Palm Beach
Florida
33409
United States
Gwinnett Research Institute
Buford
Georgia
30519
United States
IACT Health
Columbus
Georgia
31904
United States
Great Lakes Clinical Trials
Chicago
Illinois
60640
United States
Centennial Medical Group - Research Department
Elkridge
Maryland
21075
United States
Jefferson City Medical Group
Jefferson City
Missouri
65109
United States
Monroe Biomedical Research
Monroe
North Carolina
28112
United States
Wilmington Health
Wilmington
North Carolina
28412
United States
VitaLink Research
Greenville
South Carolina
29615
United States
Clinical Research of Rock Hill
Rock Hill
South Carolina
29732
United States
Fairway Medical Clinic
Houston
Texas
77087
United States
1960 Family Practice, PA
Houston
Texas
77090
United States
Zion Urgent Care Clinic
Katy
Texas
77494
United States
Family Practice Center
McAllen
Texas
78501
United States
Epic Medical Research
Red Oak
Texas
75154
United States
Debreceni Egyetem
Debrecen
4031
Hungary
King George Hospital
Visakhapatnam
Andhra Pradesh
530002
India
BAPS Pramukhswami Hospital
Surat
Gujarat
395009
India
Durgabai Deshmukh Hospital & Research Centre
Vidyānagar
Hyderabad
500044
India
Shetty's Hospital
Bengaluru
Karnataka
560068
India
Government Medical College
Aurangabad
Maharashtra
431001
India
Grant Medical College & Sir J. J. Group of Hospitals
Mumbai
Maharashtra
400008
India
Government Medical College and Hospital
Nagpur
Maharashtra
440003
India
All India Institute of Medical Sciences - Nagpur
Nagpur
Maharashtra
441108
India
VHS-Infectious Disease Medical Centre
Chennai
Tamil Nadu
600113
India
St. Theresa's Hospital
Hyderabad
Telangana
500018
India
UMC Utrecht
Utrecht
3584 CW
Netherlands
FARMOVS (Pty) Ltd
Bloemfontein
Free State
9301
South Africa
Sandton Medical Research Centre
Sandton
Gauteng
2196
South Africa
George Provincial Hospital
George
Western Cape
6529
South Africa
Dr JM Engelbrecht Trial Site
Somerset West
Western Cape
7130
South Africa
Enhancing Care Foundation
Durban
4052
South Africa
Clinresco Centres (Pty) Ltd
Kempton Park
1619
South Africa
DJW Navorsing
Krugersdorp
1739
South Africa
Jongaie Research
Pretoria
183
South Africa
Wits Clinical Research
Soweto
2013
South Africa
FG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
FG003
Placebo
Participants received single IV infusion of placebo matching with ensovibep on Day 1.
FG000100 subjects
FG001102 subjects
FG002103 subjects
FG003102 subjects
COMPLETED
FG00097 subjects
FG00195 subjects
FG00296 subjects
FG00394 subjects
NOT COMPLETED
FG0003 subjects
FG0017 subjects
FG0027 subjects
FG0038 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
Lost to Follow-up
FG0001 subjects
FG0014 subjects
FG0022 subjects
FG0032 subjects
Other
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Full analysis set (FAS) included all participants in the randomized set for whom IV infusion of study treatment was initiated during the treatment period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
BG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
BG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
BG003
Placebo
Participants received single IV infusion of placebo matching with ensovibep on Day 1.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000100
BG001100
BG002101
BG00399
BG004400
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.6± 11.50
BG00140.2± 12.90
BG00241.5± 12.84
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00047
BG00154
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
White
BG00059
BG00163
BG002
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
Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8
The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used. Time-weighted change from baseline was used as viral loads were measured at multiple time points.
The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered. Only participants included in the analysis are reported.
Posted
Least Squares Mean
Standard Error
log10 copies/milliliter (mL)
Baseline (Day 1) and Days 3, 5 and 8
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
OG003
Placebo
Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Units
Counts
Participants
OG00089
OG00197
OG00297
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.99± 0.097
OG001-1.73± 0.093
OG002-1.81± 0.093
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
ANCOVA
<0.001
Least square (LS) mean difference
-0.59
Standard Error of the Mean
0.138
2-Sided
95
-0.86
-0.32
Superiority
OG001
OG003
ANCOVA
0.014
Secondary
Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause
Percentage of participants experiencing hospitalizations (>= 24 h of acute care) and/or ER visits related to COVID-19 or death from any cause up to Day 29 were presented along with relative risk to placebo.
The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered.
Posted
Number
percentage of participants
Up to Day 29
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
OG003
Placebo
Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Secondary
Part A: Time to Sustained Clinical Recovery
Sustained clinical recovery was defined as follows;
All symptoms from the modified Food and Drug Administration (FDA) COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and
All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.
The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered. Only participants included in the analysis are reported.
Posted
Median
95% Confidence Interval
days
Up to Day 29
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
OG003
Placebo
Secondary
Part A: Observed Maximum Serum Concentration (Cmax) of Total and Free Ensovibep
Blood samples were collected to determine the Cmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The Pharmacokinetic (PK) analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram (mcg) per mL
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total and Free Ensovibep
Blood samples were collected to determine the AUClast of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Area Under the Concentration-Time Curve From Time Zero to 48 Hours (AUC 0-48h) of Total and Free Ensovibep
Blood samples were collected to determine the AUC 0-48h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Day 3
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep
Blood samples were collected to determine the AUC 0-168h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3 and 8
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC 0-336h) of Total and Free Ensovibep
Blood samples were collected to determine the AUC 0-336h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8 and 15
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinfinity) of Total and Free Ensovibep
Blood samples were collected to determine the AUCinfinity of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Time to Reach the Maximum Concentration (Tmax) of Total and Free Ensovibep
Blood samples were collected to determine the Tmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep
Blood samples were collected to determine the CL of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/h
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Terminal Elimination Rate Constant (Lambda z) of Total and Free Ensovibep
Blood samples were collected to determine the lambda z of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
per hour
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Terminal Elimination Half-Life (T1/2) of Total and Free Ensovibep
Blood samples were collected to determine the T1/2 of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Secondary
Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep
Blood samples were collected to determine the Vz of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL
Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
ID
Title
Description
OG000
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
OG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
OG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Primary
Part B: Percentage of Participants With Hospitalizations and/or Emergency Room (ER) Visits Related to COVID-19 or Death From Any Cause
Percentage of participants experiencing hospitalizations [>= 24 hour (h) of acute care] and/or ER visits related to COVID-19 or death from any cause up to Day 29.
The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.
Posted
Up to Day 29
ID
Title
Description
OG000
Phase 3/Part B: Ensovibep 75 mg
Phase 3/Part B: ensovibep active treatment. Part B was not initiated.
OG001
Phase 3/Part B: Placebo
Phase 3/Part B: Placebo. Part B was not initiated.
Units
Counts
Participants
OG000
Secondary
Part B: Change From Baseline in Log10 SARS-CoV-2 Viral Load Through Day 8
The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used.
The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.
Posted
Baseline (Day 1) and Days 3, 5 and 8
ID
Title
Description
OG000
Phase 3/Part B: Ensovibep 75 mg
Phase 3/Part B: ensovibep active treatment. Part B was not initiated.
OG001
Phase 3/Part B: Placebo
Phase 3/Part B: Placebo. Part B was not initiated.
Units
Counts
Participants
OG000
Secondary
Part B: Time to Sustained Clinical Recovery
Sustained clinical recovery was defined as follows;
All symptoms from the modified FDA COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and
All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.
The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.
Posted
Up to Day 29
ID
Title
Description
OG000
Phase 3/Part B: Ensovibep 75 mg
Phase 3/Part B: ensovibep active treatment. Part B was not initiated.
OG001
Phase 3/Part B: Placebo
Phase 3/Part B: Placebo. Part B was not initiated.
Units
Counts
Participants
OG000
Secondary
Part B: Percentage of Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Response to Ensovibep
Treatment-emergent ADA is defined as any participant with a
2-fold (1 dilution) increase in titer than the minimum required dilution if no ADAs were detected at baseline (treatment-induced ADA); or,
4-fold (2 dilutions) increase in titer compared with baseline if ADAs were detected at baseline (treatment-boosted ADA).
The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.
Posted
Pre-dose on Day 1 and Days 15, 29, 61 and 91 postdose of Ensovibep
ID
Title
Description
OG000
Phase 3/Part B: Ensovibep 75 mg
Phase 3/Part B: ensovibep active treatment. Part B was not initiated.
OG001
Phase 3/Part B: Placebo
Phase 3/Part B: Placebo. Part B was not initiated.
Units
Counts
Participants
Time Frame
Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Description
Not provided
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
Ensovibep 600 mg
Participants received single IV infusion of ensovibep 600 mg on Day 1.
0
100
0
100
51
100
EG001
Ensovibep 225 mg
Participants received single IV infusion of ensovibep 225 mg on Day 1.
0
98
2
98
40
98
EG002
Ensovibep 75 mg
Participants received single IV infusion of ensovibep 75 mg on Day 1.
0
102
1
102
40
102
EG003
Ensovibep Total
Participants received single IV infusion of ensovibep on Day 1.
0
300
3
300
131
300
EG004
Placebo
Participants received single IV infusion of placebo matching with ensovibep on Day 1.
2
100
9
100
53
100
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG0030 affected300 at risk
EG0041 affected100 at risk
Cor pulmonale
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
COVID-19
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Sepsis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Septic shock
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Paranasal sinus inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0023 affected102 at risk
EG0033 affected300 at risk
EG0040 affected100 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Haemorrhagic diathesis
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0024 affected102 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Disorder of globe
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Uveitis
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Vision blurred
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected100 at risk
EG0012 affected98 at risk
EG0021 affected102 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Asthenia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Fatigue
General disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Infusion site haematoma
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Infusion site swelling
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0012 affected98 at risk
EG0021 affected102 at risk
EG003
Pain
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Pyrexia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Swelling face
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
Nonalcoholic fatty liver disease
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Allergy to chemicals
Immune system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
COVID-19
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0006 affected100 at risk
EG0012 affected98 at risk
EG0021 affected102 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0002 affected100 at risk
EG0012 affected98 at risk
EG0020 affected102 at risk
EG003
Cystitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Eye infection bacterial
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0005 affected100 at risk
EG0011 affected98 at risk
EG0023 affected102 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Otitis media
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Pancreatitis viral
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Pharyngitis bacterial
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA (24.1)
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0007 affected100 at risk
EG0013 affected98 at risk
EG0021 affected102 at risk
EG003
Amylase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0004 affected100 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0006 affected100 at risk
EG0013 affected98 at risk
EG0021 affected102 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0003 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0006 affected100 at risk
EG0014 affected98 at risk
EG0023 affected102 at risk
EG003
Blood glucose increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Blood pressure increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
Blood sodium decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Blood sodium increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0013 affected98 at risk
EG0021 affected102 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0005 affected100 at risk
EG0012 affected98 at risk
EG0024 affected102 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0023 affected102 at risk
EG003
Haematocrit decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Lipase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0006 affected100 at risk
EG0010 affected98 at risk
EG0023 affected102 at risk
EG003
Liver function test increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Monocyte count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Monocyte count increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Platelet count increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Serum ferritin decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
White blood cell count increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0013 affected98 at risk
EG0020 affected102 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Headache
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected100 at risk
EG0012 affected98 at risk
EG0024 affected102 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Depression
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Hypertension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0012 affected98 at risk
EG0022 affected102 at risk
EG003
Phlebitis superficial
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Part B was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate. 2 patients randomized to ensovibep 225 mg didn't receive treatment they were randomized to: 1 patient received no active drug as infusion was not prepared correctly; 1 patient received lower dose (<75 mg) as infusion was interrupted. For Safety set, these 2 were reported in placebo and ensovibep 75 mg arms, respectively.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.