A Study to Evaluate the Efficacy and Safety of Remdesivir... | NCT04409262

ID	Type	Description	Link
2020-002275-34	EudraCT Number

Name	Class
Gilead Sciences	INDUSTRY

Label	Type	Description	Intervention Names
Remdesivir + Tocilizumab (RDV+TCZ)	Experimental	Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.	Drug: Remdesivir Drug: Tocilizumab
Remdesivir + Placebo (RDV+Placebo)	Active Comparator	Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.	Drug: Remdesivir Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Remdesivir	Drug	Participants will receive intravenous (IV) RDV	Remdesivir + Placebo (RDV+Placebo) Remdesivir + Tocilizumab (RDV+TCZ)

Measure	Description	Time Frame
Time to Hospital Discharge or "Ready for Discharge" up to Day 28	Defined as days from randomization to hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Hospital discharge or "Ready for Discharge" is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \	Up to Day 28

Measure	Description	Time Frame
Time to Mechanical Ventilation or Death up to Day 28	Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.	Up to Day 28

Measure	Description	Time Frame
Percentage of Participants With Adverse Events (AEs) Tabulated by Severity	AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE Participants are counted at the highest AE grade experienced.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Valleywise Health Medical Center		Phoenix	Arizona	85008	United States
eStudySite - Chula Vista - PPDS

ID	Title	Description
FG000	Remdesivir + Placebo (RDV+PBO)	Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 22, 2021	Jan 28, 2022

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

Time to Hospital Discharge or "Ready for Discharge" up to Day 28

Defined as days from randomization to hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Hospital discharge or "Ready for Discharge" is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28.

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Posted

Median

95% Confidence Interval

days

Up to Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+Placebo) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Units	Counts
Participants	OG000210 OG001430

Title

Denominators

Categories

Title	Measurements
	OG00014.0(11.0 to 16.0) OG00114.0(12.0 to 15.0)

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		Log Rank		0.7414		Hazard Ratio (HR)	0.965			2-Sided	95	0.78	1.19					Superiority

Secondary

Time to Mechanical Ventilation or Death up to Day 28

Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.

Posted

Median

95% Confidence Interval

Days

Up to Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Units	Counts
Participants	OG000

Secondary

Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14

Clinical status was assessed by the investigator according to the following ordinal scale categories:

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 14 and were excluded from analysis for this endpoint.

Posted

Number

Percentage of Participants

Day 14

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Time to Death up to Day 28

Time to death is defined as the time from randomization to death.

Posted

Median

95% Confidence Interval

Days

Up to Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Units	Counts
Participants	OG000

Secondary

Time to Death up to Day 60

Time to death is defined as the time from randomization to death.

Posted

Median

95% Confidence Interval

Days

Up to Day 60

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+Placebo) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Units	Counts
Participants	OG000

Secondary

Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28

Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Patients who die are censored at day 28.

Clinical status was assessed by the investigator according to the following ordinal scale categories:

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Posted

Median

95% Confidence Interval

Days

Up to Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7

Clinical status was assessed by the investigator according to the following ordinal scale categories:

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 7 and were excluded from analysis for this endpoint.

Posted

Number

Percentage of participants

Day 7

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21

Clinical status was assessed by the investigator according to the following ordinal scale categories:

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 21 and were excluded from analysis for this endpoint.

Posted

Number

Percentage of Participants

Day 21

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28

Clinical status was assessed by the investigator according to the following ordinal scale categories:

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 28 and were excluded from analysis for this endpoint.

Posted

Number

Percentage of Participants

Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60

Clinical status was assessed by the investigator according to the following ordinal scale categories:

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 60 and were excluded from analysis for this endpoint.

Posted

Number

Percentage of Participants

Day 60

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)

Day 28: Participants who withdraw or die prior to Day 28 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 28, which are counted as an event.

Day 60: Participants who withdraw or die prior to Day 60 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 60, which are counted as an event.

The analysis population for this endpoint included only participants not on mechanical ventilation at baseline

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 28 and Day 60

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)

The analysis population for this endpoint included only participants on mechanical ventilation at baseline.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 28 and Day 60

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Units	Counts
Participants	OG000

Secondary

Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28

Participants who die by Day 28 are assigned a duration of 28 days.

The analysis population for this endpoint included only participants on mechanical ventilation at baseline.

Posted

Mean

95% Confidence Interval

Days

Up to Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Units	Counts
Participants	OG000

Secondary

Difference in Mortality at Days 14, 28, and 60

Posted

Number

95% Confidence Interval

Percentage of Participants

Days 14, 28, and 60

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Units	Counts
Participants	OG000

Secondary

Time to Recovery up to Day 28

Defined as the time from randomization to the time when an ordinal scale category of 2 (non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen) or better is observed, not followed by ordinal scale category >2 or death. Participants who die are censored at day 28.

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Posted

Median

95% Confidence Interval

Days

Up to Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Proportion of Participants Who Are Discharged or "Ready for Discharge" up to Day 28

Defined as hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death.

Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Secondary

Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28

Participants already on mechanical ventilation at baseline are only counted as an event if death occurs.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Day 28

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population	The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.

Units	Counts
Participants	OG000

Other Pre-specified

Percentage of Participants With Adverse Events (AEs) Tabulated by Severity

AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE

Participants are counted at the highest AE grade experienced.

Participants that only received RDV and did not receive TCZ/PBO were included in the RDV+PBO arm of the safety population.

Posted

Number

Percentage of participants

Up to Day 60

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - Safety Population	The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - Safety Population	The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.

Other Pre-specified

Proportion of Participants With Any Post-Treatment Infection

Participants that only received RDV and did not receive TCZ/PBO were included in the RDV+PBO arm of the safety population.

Posted

Number

Percentage of Participants

Up to Day 60

ID	Title	Description
OG000	Remdesivir + Placebo (RDV+PBO) - Safety Population	The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.
OG001	Remdesivir + Tocilizumab (RDV+TCZ) - Safety Population	The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk
Bicytopenia	Blood and lymphatic system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0012 events2 affected429 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Bradycardia	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Cardiac arrest	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0003 events3 affected213 at risk EG0012 events2 affected429 at risk
Cardiac failure	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0011 events1 affected429 at risk
Cardiogenic shock	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0013 events3 affected429 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Myocarditis	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Sinus bradycardia	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Colitis	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0013 events3 affected429 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Brain death	General disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Catheter site haemorrhage	General disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0013 events2 affected429 at risk
Death	General disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0012 events2 affected429 at risk
Hypothermia	General disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0012 events2 affected429 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Liver injury	Hepatobiliary disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk
Bacteraemia	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0003 events2 affected213 at risk EG0010 events0 affected429 at risk
Bacterial sepsis	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk
COVID-19	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0008 events8 affected213 at risk EG00114 events14 affected429 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG00027 events27 affected213 at risk EG00136 events36 affected429 at risk
Clostridium difficile infection	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Device related sepsis	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Enterobacter infection	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Fungaemia	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Pneumonia	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0006 events6 affected213 at risk EG00122 events21 affected429 at risk
Pneumonia acinetobacter	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0012 events2 affected429 at risk
Pneumonia bacterial	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0004 events4 affected213 at risk EG0015 events5 affected429 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Pulmonary sepsis	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0011 events1 affected429 at risk
Sepsis	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0007 events6 affected213 at risk EG00113 events11 affected429 at risk
Septic shock	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG00010 events10 affected213 at risk EG00123 events23 affected429 at risk
Staphylococcal infection	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Systemic candida	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0010 events0 affected429 at risk
Tracheobronchitis	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0011 events1 affected429 at risk
Urinary tract infection	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0003 events3 affected213 at risk EG0014 events4 affected429 at risk
Urosepsis	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0010 events0 affected429 at risk
Vascular device infection	Infections and infestations	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Blood culture positive	Investigations	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Hepatic enzyme increased	Investigations	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Platelet count decreased	Investigations	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Transaminases increased	Investigations	MedDRA v 23.1	Non-systematic Assessment	EG0003 events3 affected213 at risk EG0011 events1 affected429 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Aphasia	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Brain compression	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Brain oedema	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0015 events5 affected429 at risk
Embolic stroke	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Encephalopathy	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0015 events5 affected429 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0010 events0 affected429 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0002 events2 affected213 at risk EG0011 events1 affected429 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Neurotoxicity	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Presyncope	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Mental status changes	Psychiatric disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v 23.1	Non-systematic Assessment	EG00014 events14 affected213 at risk EG00121 events21 affected429 at risk
Renal failure	Renal and urinary disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0015 events5 affected429 at risk
Renal impairment	Renal and urinary disorders	MedDRA v 23.1	Non-systematic Assessment	EG0005 events5 affected213 at risk EG0011 events1 affected429 at risk
Renal injury	Renal and urinary disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0013 events3 affected429 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0015 events5 affected429 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0013 events3 affected429 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0017 events7 affected429 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0003 events3 affected213 at risk EG0015 events5 affected429 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0011 events1 affected429 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk
Aortic thrombosis	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Haematoma	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0011 events1 affected429 at risk
Haemodynamic instability	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Hypertension	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Hypotension	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0004 events4 affected213 at risk EG0014 events4 affected429 at risk
Hypovolaemic shock	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Peripheral ischaemia	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0001 events1 affected213 at risk EG0010 events0 affected429 at risk
Shock	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0014 events4 affected429 at risk
Shock haemorrhagic	Vascular disorders	MedDRA v 23.1	Non-systematic Assessment	EG0000 events0 affected213 at risk EG0012 events2 affected429 at risk

ID	Term
C000606551	remdesivir
C502936	tocilizumab

ID	Title	Description
BG000	Remdesivir + Placebo (RDV+PBO)	Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.
BG001	Remdesivir + Tocilizumab (RDV+TCZ)	Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of TCZ on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of TCZ was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.
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	Remdesivir + Placebo (RDV+PBO)	Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.	55	213	76	213	70	213
EG001	Remdesivir + Tocilizumab (RDV+TCZ)	Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of TCZ on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of TCZ was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.	97	429	141	429	144	429