Aviptadil for Severely Ill Inpatients With COVID-19 (An A... | NCT06729606

Name	Class
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)	NETWORK
University of Copenhagen	OTHER
Medical Research Council	OTHER_GOV

Label	Type	Description	Intervention Names
Aviptadil + SOC	Experimental		Biological: Aviptadil Drug: Corticosteroid
Placebo + SOC	Placebo Comparator		Biological: Aviptadil Placebo Drug: Corticosteroid

Name	Type	Description	Arm Group Labels	Other Names
Aviptadil	Biological	Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr.

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

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

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)

ID	Title	Description
FG000	Aviptadil + SOC	Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761). Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Aviptadil (H1)	Mar 8, 2022	Jun 27, 2025

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.

6 participants in the Aviptadil+SOC arm and 5 participants in the Placebo+SOC arm did not have the day 90 status available to compute the primary endpoint. These participants were excluded from the analysis.

Posted

Count of Participants

Participants

Status on Day 90

ID	Title	Description
OG000	Aviptadil + SOC	Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
OG001	Placebo + SOC	Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.

Units	Counts
Participants	OG000225 OG001225

Title

Denominators

Categories

Title	Measurements
category 1 = at home and off oxygen (recovered) for at least 77 days	OG00036 OG00131
category 2 = at home and off oxygen for 49-76 days	OG000

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 OG001		Proportional odds model		0.54	Proportional odds model stratified by disease severity (high flow nasal canula [HFNC]/non-invasive ventilation [NIV] or invasive mechanical ventiliation [IMV]/ECMO) at study entry to determine the odds of being in a better category at day 90.	Odds Ratio (OR)	1.11			2-Sided	95	0.80	1.55			Summary odds ratio for being in a better category, active/placebo (95% confidence interval); pvalue		Superiority

Secondary

Number of Participants Who Died Through Day 90

Posted

Count of Participants

Participants

Through Day 90

ID	Title	Description
OG000	Aviptadil + SOC	Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
OG001	Placebo + SOC	Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.

Units	Counts
Participants

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

ID	Title	Description
OG000	Aviptadil + SOC	Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
OG001	Placebo + SOC	Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.

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

ID	Title	Description
OG000	Aviptadil + SOC	Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
OG001	Placebo + SOC	Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.

Secondary

Number of Participants Who Died Through Day 180

Posted

Count of Participants

Participants

Through Day 180

ID	Title	Description
OG000	Aviptadil + SOC	Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
OG001	Placebo + SOC	Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected231 at risk EG0014 events4 affected230 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0012 events2 affected230 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0013 events2 affected230 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected231 at risk EG0010 events0 affected230 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Angina pectoris	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Arrhythmia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected231 at risk EG00113 events12 affected230 at risk
Bradycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG00021 events18 affected231 at risk EG00133 events22 affected230 at risk
Cardiac arrest	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0005 events4 affected231 at risk EG0013 events3 affected230 at risk
Cardiac failure	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0012 events2 affected230 at risk
Extrasystoles	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Myocardial infarction	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Palpitations	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected231 at risk EG0010 events0 affected230 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0011 events1 affected230 at risk
Right ventricular failure	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0013 events3 affected230 at risk
Tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG00027 events25 affected231 at risk EG00121 events15 affected230 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0014 events4 affected230 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Eye oedema	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0012 events2 affected230 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0015 events4 affected230 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00014 events13 affected231 at risk EG0015 events5 affected230 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0014 events4 affected230 at risk
Flatulence	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0005 events4 affected231 at risk EG0010 events0 affected230 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Ileus	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0011 events1 affected230 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Melaena	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0008 events7 affected231 at risk EG0018 events7 affected230 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0012 events2 affected230 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0013 events3 affected230 at risk
Chest discomfort	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Chills	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0016 events6 affected230 at risk
Complication associated with device	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0006 events2 affected231 at risk EG0010 events0 affected230 at risk
Flushing	General disorders	MedDRA 25.1	Systematic Assessment	EG00048 events34 affected231 at risk EG00120 events14 affected230 at risk
Hyperhidrosis	General disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected231 at risk EG0011 events1 affected230 at risk
Hypothermia	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Infusion site extravasation	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Non-cardiac chest pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Oedema	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG00049 events33 affected231 at risk EG00145 events31 affected230 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Multisystem inflammatory syndrome	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0011 events1 affected230 at risk
Multisystem inflammatory syndrome in adults	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Urticaria	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0013 events2 affected230 at risk
Abdominal abscess	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected231 at risk EG0010 events0 affected230 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Candida infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0011 events1 affected230 at risk
Fungaemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Fungal infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Haemophilus bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Helicobacter infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Parotitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0008 events8 affected231 at risk EG0017 events7 affected230 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected231 at risk EG0014 events4 affected230 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0013 events3 affected230 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected231 at risk EG0013 events3 affected230 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected231 at risk EG0017 events7 affected230 at risk
Respiratory tract infection fungal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected231 at risk EG0015 events5 affected230 at risk
Septic shock	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00012 events12 affected231 at risk EG00116 events14 affected230 at risk
Sinusitis bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0014 events4 affected230 at risk
Staphylococcal infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0013 events2 affected230 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Viral sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Barotrauma	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Post procedural hypotension	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Substance-induced psychotic disorder	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Vascular access site erythema	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Haemoglobin decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Urine output decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0005 events3 affected231 at risk EG0012 events2 affected230 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0008 events7 affected231 at risk EG0015 events3 affected230 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0012 events2 affected230 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected231 at risk EG0010 events0 affected230 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0005 events4 affected231 at risk EG0012 events2 affected230 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0008 events4 affected231 at risk EG0011 events1 affected230 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Areflexia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0013 events3 affected230 at risk
Encephalopathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected231 at risk EG0015 events4 affected230 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG00016 events14 affected231 at risk EG00111 events7 affected230 at risk
Intensive care unit acquired weakness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected231 at risk EG0012 events2 affected230 at risk
Paraesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Polyneuropathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Presyncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Seizure	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Somnolence	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Syncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Agitation	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0013 events3 affected230 at risk
Anxiety	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0005 events4 affected231 at risk EG0011 events1 affected230 at risk
Confusional state	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0013 events3 affected230 at risk
Delirium	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected231 at risk EG0012 events2 affected230 at risk
Intensive care unit delirium	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Mental status changes	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0011 events1 affected230 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG00019 events16 affected231 at risk EG00128 events22 affected230 at risk
Anuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Azotaemia	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Haematuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Oliguria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Renal failure	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0016 events6 affected230 at risk
Renal impairment	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Renal injury	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected230 at risk
Renal tubular dysfunction	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Urinary retention	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected231 at risk EG0014 events4 affected230 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0006 events5 affected231 at risk EG0014 events4 affected230 at risk
Bradypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected231 at risk EG0013 events3 affected230 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected231 at risk EG0018 events8 affected230 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected231 at risk EG0010 events0 affected230 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00020 events14 affected231 at risk EG00116 events11 affected230 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected231 at risk EG0012 events2 affected230 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00010 events9 affected231 at risk EG0015 events5 affected230 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected231 at risk EG0013 events3 affected230 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0006 events4 affected231 at risk EG0012 events2 affected230 at risk
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0013 events3 affected230 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00013 events12 affected231 at risk EG00114 events14 affected230 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected231 at risk EG0012 events2 affected230 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0013 events3 affected230 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0008 events5 affected231 at risk EG0013 events2 affected230 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Endotracheal intubation	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Haemofiltration	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Renal replacement therapy	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG00010 events10 affected231 at risk EG00118 events16 affected230 at risk
Distributive shock	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected230 at risk
Flushing	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Hot flush	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected230 at risk
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG00061 events42 affected231 at risk EG00156 events38 affected230 at risk
Hypotension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG000709 events159 affected231 at risk EG001687 events140 affected230 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk
Shock	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG00112 events6 affected230 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected230 at risk
Venous thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected230 at risk

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

ID	Term
C438273	aviptadil
D014660	Vasoactive Intestinal Peptide
D000305	Adrenal Cortex Hormones

ID	Term
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D036361	Peptide Hormones
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009419	Nerve Tissue Proteins
D011506	Proteins

ID	Title	Description
BG000	Aviptadil + SOC	Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. 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 Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aviptadil + SOC	Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	90	231	25	231	200	231
EG001	Placebo + SOC	Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	86	230	23	230	176	230