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| Name | Class |
|---|---|
| International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) | NETWORK |
| University of Copenhagen | OTHER |
| Medical Research Council | OTHER_GOV |
Not provided
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This study looks at the safety and effectiveness of Remdesivir in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Remdesivir plus current standard of care (SOC), or with placebo plus current SOC.
This is a treatment trial of the ACTIV-3b/TESICO master protocol (NCT04843761) to evaluate the safety and efficacy of Remdesivir at improving outcomes for patients with acute respiratory failure related to COVID-19.
This protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol.
This protocol will be conducted in up to several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.
The protocol is for a Phase 3 study.
Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days.
This study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at Day 90 for Remdesivir versus placebo with use of the ordinal outcome. The planned sample size is 320 participants. Sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio.
Randomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) at enrollment. Other agent-specific stratification factors may be considered.
An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remdesivir + SOC | Experimental |
| |
| Placebo + SOC | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Biological | Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 | The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead. | Status on Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died Through Day 90 | Through Day 90 | |
| Number of Participants With a Safety Outcome Through Day 5 | Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 5 |
Not provided
Inclusion Criteria:
Refer to the master protocol (NCT04843761)
Exclusion Criteria:
Refer to the master protocol (NCT04843761)
Additional Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Brown, MD | Intermountain Medical Center/University of Utah | Principal Investigator |
| Prof. James Neaton | INSIGHT Statistical and Coordinating Centre, University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue | Tucson | Arizona | 85719 | United States | ||
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
| CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website | View source |
| A Participant's Guide to Clinical Trials (NIAID) |
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This substudy presents analysis for Remdesivir vs Remdesivir Placebo. Per protocol, this comparison was conducted among the pooled cohort of participants who were randomized to receive active Remdesivir or Remdesvir Placebo within randomization strata 1 and 3 of the master protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Remdesivir + SOC | Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Remdesivir (H2) | Apr 1, 2021 |
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| Kirby Institute |
| OTHER_GOV |
| Washington D.C. Veterans Affairs Medical Center | FED |
| Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | NETWORK |
| US Department of Veterans Affairs | FED |
| Prevention and Early Treatment of Acute Lung Injury (PETAL) Network | UNKNOWN |
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
| Remdesivir Placebo | Biological | Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. |
|
| Corticosteroid | Drug | In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. |
|
| Through Day 5 |
| Number of Participants With a Safety Outcome Through Day 28 | Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 28 | Through Day 28 |
| Number of Participants Who Died Through Day 180 | Through Day 180 |
| UCSF Fresno (Site 203-005), 155 N. Fresno Street |
| Fresno |
| California |
| 93701 |
| United States |
| VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street | Loma Linda | California | 92357 | United States |
| Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard | Los Angeles | California | 90048 | United States |
| Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza | Los Angeles | California | 90095 | United States |
| UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St. | San Francisco | California | 94115 | United States |
| UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave. | San Francisco | California | 94143 | United States |
| Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr. | Stanford | California | 94305 | United States |
| University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue | Aurora | Colorado | 80045 | United States |
| Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B | Denver | Colorado | 80204 | United States |
| MedStar Health Research Institute (Site 009-021), 110 Irving St., NW. | Washington D.C. | District of Columbia | 20010 | United States |
| Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW. | Washington D.C. | District of Columbia | 20422 | United States |
| Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE. | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital (Site 202-002), 55 Fruit Street | Boston | Massachusetts | 02114 | United States |
| Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street | Springfield | Massachusetts | 01199 | United States |
| Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave. | New York | New York | 10032 | United States |
| Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street | The Bronx | New York | 10467 | United States |
| Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street | The Bronx | New York | 10467 | United States |
| Duke University Hospital (Site 301-006), 2301 Erwin Road | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Health (Site 210-001), Medical Center Blvd | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740 | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Ave. | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave. | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue | Columbus | Ohio | 43210 | United States |
| Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road | Garfield Heights | Ohio | 44125 | United States |
| Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road | Mayfield Heights | Ohio | 44124 | United States |
| Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd. | Portland | Oregon | 97239-3098 | United States |
| Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214 | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive | Nashville | Tennessee | 37232 | United States |
| Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave. | Dallas | Texas | 75246 | United States |
| Houston Methodist Hospital (Site 301-028), 6565 Fannin Street | Houston | Texas | 77030 | United States |
| Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266 | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center (Site 203-006), 7000 Fannin St. | Houston | Texas | 77030 | United States |
| Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street | Murray | Utah | 84107 | United States |
| University of Utah Hospital (Site 211-002), 50 North Medical Drive | Salt Lake City | Utah | 84132 | United States |
| UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St. | Charlottesville | Virginia | 22908 | United States |
| Harborview Medical Center (Site 208-001), 325 9th Ave. | Seattle | Washington | 98104 | United States |
| Swedish Medical Center (Site 208-005), 747 Broadway | Seattle | Washington | 98122 | United States |
| West Virginia University Medicine (Site 301-023), One Medical Center Drive | Morgantown | West Virginia | 26506 | United States |
| View source |
| Find a Clinical Trial (NIAID) | View source |
| Clinical Trials at NIAID | View source |
| National Institute for Allergy and Infectious Diseases (NIAID) | View source |
| WHO COVID-19 treatment guidelines | View source |
| FG001 | Placebo + SOC | Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Remdesivir + SOC | Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. |
| BG001 | Placebo + SOC | Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 | The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead. | 1 participant in the remdesivir arm did not have the day 90 status available to compute the primary endpoint. This participant was excluded from the analysis. | Posted | Count of Participants | Participants | Status on Day 90 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died Through Day 90 | Posted | Count of Participants | Participants | Through Day 90 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Safety Outcome Through Day 5 | Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 5 | Posted | Count of Participants | Participants | Through Day 5 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Safety Outcome Through Day 28 | Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 28 | Posted | Count of Participants | Participants | Through Day 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died Through Day 180 | Posted | Count of Participants | Participants | Through Day 180 |
|
|
All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28.
Adverse events were collected irrespective of mono or dual therapy assignment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remdesivir + SOC | Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. | 19 | 44 | 9 | 44 | 27 | 44 |
| EG001 | Placebo + SOC | Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. | 21 | 43 | 2 | 43 | 31 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Computerised tomogram thorax abnormal | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Enterobacter pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Post procedural hypotension | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haemofiltration | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shweta Sharma Mistry | University of Minnesota | 612-626-9021 | shwetas@ccbr.umn.edu |
| Jun 27, 2025 |
| Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Master | Mar 8, 2022 | Aug 6, 2025 | Prot_005.pdf |
| Prot | Yes | No | No | Study Protocol: Aviptadil (H1) | Mar 8, 2022 | Aug 6, 2025 | Prot_006.pdf |
| Prot | Yes | No | No | Study Protocol: Trial Document Overview | Aug 5, 2025 | Aug 6, 2025 | Prot_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Addendum | May 1, 2022 | Jun 27, 2025 | SAP_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Main | Aug 5, 2021 | Aug 6, 2025 | SAP_008.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2022 | Jul 31, 2025 | ICF_009.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D003333 | Coronaviridae Infections |
| D018352 | Coronavirus Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D030341 | Nidovirales Infections |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000606551 | remdesivir |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Other |
|
| Only ethnicity (race unknown) |
|
| category 3 = at home and off oxygen for 1-48 days |
|
| category 4 = not hospitalized but either on supplemental oxygen or not at home |
|
| category 5 = hospitalized or in hospice care |
|
| category 6 = died |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|