Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

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ClinicalTrials.gov Identifier: NCT04292899

Recruitment Status : Completed

First Posted : March 3, 2020

Results First Posted : December 31, 2020

Last Update Posted : December 31, 2020

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Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	COVID-19
Interventions	Drug: Remdesivir Drug: Standard of Care
Enrollment	4891

Participant Flow

Recruitment Details	Participants were enrolled at study sites in the United States, Europe, and Asia. The first participant was screened on 06 March 2020. The last study visit occurred on 30 June 2020.
Pre-assignment Details	4958 participants were screened. 4891 participants were enrolled. 4 participants in Part A and 49 participants in Part B did not receive treatment and are not included in the analyses.


Arm/Group Title	Part A: Remdesivir (RDV) for 5 Days	Part A: Remdesivir for 10 Days	Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)	Part B: Remdesivir for 10 Days (Extension Group)
Arm/Group Description	Participants received continued sta...	Participants received continued SOC...	Participants on mechanical ventilat...	Participants who were not mechanica...
Arm/Group Description	Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
Period Title: Overall Study
Started	200	197	844	3597
Completed	168	164	621	2952
Not Completed	32	33	223	645
Reason Not Completed
Death	21	28	188	371
Lost to Follow-up	8	4	22	235
Withdrew consent	1	0	11	32
Adverse Event	2	1	2	2
Investigator's Discretion	0	0	0	3
Non-compliance With Study Drug	0	0	0	1
Protocol Violation	0	0	0	1

Baseline Characteristics

Arm/Group Title		Part A: Remdesivir (RDV) for 5 Days	Part A: Remdesivir for 10 Days	Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)	Part B: Remdesivir for 10 Days (Extension Group)	Total
Arm/Group Description		Participants received continued SOC...	Participants received continued SOC...	Participants on mechanical ventilat...	Participants who were not mechanica...	Total of all reporting groups
Arm/Group Description		Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Total of all reporting groups
Overall Number of Baseline Participants		200	197	844	3597	4838
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment. Part B: Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study treatment.
Age, Customized Measure Type: Count of Participants Unit of measure: Participants
Age Categories	Number Analyzed	200 participants	197 participants	844 participants	3597 participants	4838 participants
	< 65	116	113	581	2399	3209
	≥ 65	84	84	263	1198	1629
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	200 participants	197 participants	844 participants	3597 participants	4838 participants
	Female	80	64	312	1351	1807
	Male	120	133	532	2246	3031
Race/Ethnicity, Customized ^[1] Measure Type: Count of Participants Unit of measure: Participants
Race	Number Analyzed	200 participants	197 participants	844 participants	3597 participants	4838 participants
	American Indian or Alaska Native	2	0	5	40	47
	Asian	20	25	88	313	446
	Black	21	23	149	611	804
	Native Hawaiian or Pacific Islander	1	0	11	29	41
	White	142	134	376	1915	2567
	Not Permitted	0	5	56	179	240
	Other	14	10	159	510	693
		[1] Measure Description: Not Permitted means local regulators did not allow collection of ethnicity information.
Race/Ethnicity, Customized ^[1] Measure Type: Count of Participants Unit of measure: Participants
Ethnicity	Number Analyzed	200 participants	197 participants	844 participants	3597 participants	4838 participants
	Hispanic or Latino	47	38	328	1341	1754
	Not Hispanic or Latino	152	150	478	2123	2903
	Not Permitted	1	9	37	129	176
	Missing	0	0	1	4	5
		[1] Measure Description: Measure Description: Not Permitted means local regulators did not allow collection of ethnicity information.
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	200 participants	197 participants	844 participants	3597 participants	4838 participants
United States		118	111	722	2927	3878
Spain		31	30	27	134	222
Italy		39	38	16	108	201
United Kingdom		0	0	33	144	177
Sweden		0	0	5	83	88
Singapore		1	8	7	44	60
Switzerland		0	0	13	44	57
Netherlands		0	0	2	45	47
Germany		3	1	12	27	43
France		0	0	2	25	27
South Korea		6	6	0	10	22
Hong Kong		2	2	2	0	6
Japan		0	0	1	4	5
Taiwan		0	1	2	2	5
Clinical Status (7-point ordinal scale) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	200 participants	197 participants	844 participants	3597 participants	4838 participants
	Score: 1	0	0	0	0	0
	Score: 2	4	9	844	0	857
	Score: 3	49	59	0	1069	1177
	Score: 4	113	108	0	2214	2435
	Score: 5	34	21	0	314	369
	Score: 6	0	0	0	0	0
	Score: 7	0	0	0	0	0
		[1] Measure Description: The 7-point ordinal scale is an assessment of the clinical status of participant at a given study day:1. Death;2.Hospitalized,on invasive mechanical ventilation or extracorporeal membrane oxygenation(ECMO);3.Hospitalized, on noninvasive ventilation or high-flow oxygen devices;4.Hospitalized,requiring low-flow supplemental oxygen;5.Hospitalized,not requiring supplemental oxygen - requiring ongoing medical care(COVID-19 related or otherwise);6.Hospitalized,not requiring supplemental oxygen - no longer requiring ongoing medical care(other than per-protocol RDV administration);7.Not hospitalized.

Outcome Measures

1.Primary Outcome


Title	Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14
Description	Clinical status was derived from death, hospital discharge, and the or...
Description	Clinical status was derived from death, hospital discharge, and the ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration); 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for the Remdesivir for 10 days group vs the Remdesivir for 5 days group.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

Full Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment.


Arm/Group Title	Part A: Remdesivir (RDV) for 5 Days	Part A: Remdesivir for 10 Days
Arm/Group Description:	Participants received continued SOC...	Participants received continued SOC...
Arm/Group Description:	Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
Overall Number of Participants Analyzed	200	197
Measure Type: Number Unit of Measure: percentage of participants
Score: 1	8.0	10.7
Score: 2	8.5	16.8
Score: 3	4.0	5.1
Score: 4	9.5	7.6
Score: 5	6.0	6.1
Score: 6	4.0	1.5
Score: 7	60.0	52.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Remdesivir (RDV) for 5 Days, Part A: Remdesivir for 10 Days
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1563
	Comments	P-value was calculated using a proportional odds model with treatment as the independent variable and baseline clinical status as a continuous covariate.
	Method	Proportional odds model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95% 0.507 to 1.115
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part A: Remdesivir (RDV) for 5 Days, Part A: Remdesivir for 10 Days
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0368
	Comments	P-value was calculated using a proportional odds model with treatment as the independent variable.
	Method	Proportional odds model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95% 0.458 to 0.976
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Description	Treatment-emergent Adverse Events (TEAE) were defined as AEs with onse...
Description	Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.
Time Frame	First dose date up to last dose date (maximum: 10 days) plus 30 days

Outcome Measure Data

Analysis Population Description

Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study drug


Arm/Group Title	Part A: Remdesivir (RDV) for 5 Days	Part A: Remdesivir for 10 Days
Arm/Group Description:	Participants received continued SOC...	Participants received continued SOC...
Arm/Group Description:	Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
Overall Number of Participants Analyzed	200	197
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	71.5 (64.7 to 77.6)	75.1 (68.5 to 81.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Remdesivir (RDV) for 5 Days, Part A: Remdesivir for 10 Days
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7678
	Comments	P-value for comparison of the percentages between the two groups was calculated using the Cochran-Mantel-Haenszel test stratified on baseline clinical status.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95% -7.4 to 10.0
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Part A: First dose date up to the last dose date (maximum: 10 days) plus 30 days; Part B: First dose date up to the last dose date (maximum: 11 days) plus 30 days
Adverse Event Reporting Description	Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment;Part B: Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study treatment.

Arm/Group Title	Part A: Remdesivir (RDV) for 5 Days	Part A: Remdesivir for 10 Days	Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)	Part B: Remdesivir for 10 Days (Extension Group)
Arm/Group Description	Participants received continued SOC...	Participants received continued SOC...	Participants on mechanical ventilat...	Participants who were not mechanica...
Arm/Group Description	Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.	Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.	Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
All-Cause Mortality
	Part A: Remdesivir (RDV) for 5 Days	Part A: Remdesivir for 10 Days	Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)	Part B: Remdesivir for 10 Days (Extension Group)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	25/200 (12.50%)	28/197 (14.21%)	213/844 (25.24%)	422/3597 (11.73%)
Serious Adverse Events Serious Adverse Events
	Part A: Remdesivir (RDV) for 5 Days	Part A: Remdesivir for 10 Days	Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)	Part B: Remdesivir for 10 Days (Extension Group)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	43/200 (21.50%)	68/197 (34.52%)	362/844 (42.89%)	851/3597 (23.66%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/200 (0.00%)	1/197 (0.51%)	4/844 (0.47%)	9/3597 (0.25%)
Bicytopenia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Blood loss anaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Bone marrow failure ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Coagulopathy ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Disseminated intravascular coagulation ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	3/3597 (0.08%)
Leukocytosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Neutropenia ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	0/3597 (0.00%)
Splenic infarction ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Thrombocytopenia ^† 1	1/200 (0.50%)	0/197 (0.00%)	0/844 (0.00%)	0/3597 (0.00%)
Cardiac disorders
Acute myocardial infarction ^† 1	0/200 (0.00%)	1/197 (0.51%)	4/844 (0.47%)	2/3597 (0.06%)
Angina pectoris ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Arrhythmia ^† 1	1/200 (0.50%)	0/197 (0.00%)	3/844 (0.36%)	3/3597 (0.08%)
Atrial fibrillation ^† 1	0/200 (0.00%)	0/197 (0.00%)	10/844 (1.18%)	12/3597 (0.33%)
Atrial flutter ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Atrioventricular block complete ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	3/3597 (0.08%)
Atrioventricular block second degree ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Bradycardia ^† 1	1/200 (0.50%)	0/197 (0.00%)	2/844 (0.24%)	3/3597 (0.08%)
Cardiac arrest ^† 1	0/200 (0.00%)	2/197 (1.02%)	15/844 (1.78%)	34/3597 (0.95%)
Cardiac failure ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	2/3597 (0.06%)
Cardiac failure acute ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	1/3597 (0.03%)
Cardiac failure congestive ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Cardio-respiratory arrest ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	11/3597 (0.31%)
Cardiogenic shock ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	5/3597 (0.14%)
Cardiomyopathy ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	1/3597 (0.03%)
Cyanosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Myocardial infarction ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	4/3597 (0.11%)
Myocardial ischaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Pericarditis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pulseless electrical activity ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	5/3597 (0.14%)
Right ventricular dysfunction ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	0/3597 (0.00%)
Right ventricular failure ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Stress cardiomyopathy ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Supraventricular tachycardia ^† 1	1/200 (0.50%)	0/197 (0.00%)	2/844 (0.24%)	1/3597 (0.03%)
Tachycardia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Ventricular arrhythmia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Ventricular fibrillation ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Ventricular tachycardia ^† 1	1/200 (0.50%)	0/197 (0.00%)	2/844 (0.24%)	1/3597 (0.03%)
Gastrointestinal disorders
Abdominal pain ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Abdominal wall haematoma ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Colitis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Diverticular perforation ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Duodenal ulcer ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Dysphagia ^† 1	1/200 (0.50%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Gastric perforation ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Gastrointestinal haemorrhage ^† 1	0/200 (0.00%)	1/197 (0.51%)	1/844 (0.12%)	3/3597 (0.08%)
Haematemesis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	3/3597 (0.08%)
Ileus ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Ileus paralytic ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Intestinal ischaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	3/844 (0.36%)	2/3597 (0.06%)
Intestinal pseudo-obstruction ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Intra-abdominal haematoma ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Lower gastrointestinal haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	1/3597 (0.03%)
Pancreatitis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Pancreatitis acute ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pancreatitis necrotising ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pneumatosis intestinalis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Rectal haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Retroperitoneal haematoma ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	1/3597 (0.03%)
Retroperitoneal haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	2/3597 (0.06%)
Stomatitis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Upper gastrointestinal haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Vomiting ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
General disorders
Asthenia ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	0/3597 (0.00%)
Brain death ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Chest pain ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Death ^† 1	1/200 (0.50%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Fatigue ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Hyperthermia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Hyperthermia malignant ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	0/3597 (0.00%)
Multi-organ disorder ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Multiple organ dysfunction syndrome ^† 1	2/200 (1.00%)	4/197 (2.03%)	27/844 (3.20%)	32/3597 (0.89%)
Oedema ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Oedema peripheral ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pelvic mass ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Procedural failure ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Pyrexia ^† 1	0/200 (0.00%)	1/197 (0.51%)	4/844 (0.47%)	5/3597 (0.14%)
Hepatobiliary disorders
Acute hepatic failure ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Biliary colic ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Hepatic failure ^† 1	1/200 (0.50%)	0/197 (0.00%)	2/844 (0.24%)	1/3597 (0.03%)
Hyperbilirubinaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Hypertransaminasaemia ^† 1	0/200 (0.00%)	1/197 (0.51%)	1/844 (0.12%)	0/3597 (0.00%)
Ischaemic hepatitis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Immune system disorders
Cytokine release syndrome ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	5/3597 (0.14%)
Cytokine storm ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	2/3597 (0.06%)
Drug hypersensitivity ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Hypersensitivity ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Infections and infestations
Abdominal abscess ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Abdominal sepsis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Bacteraemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	7/844 (0.83%)	3/3597 (0.08%)
Bronchopulmonary aspergillosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Cellulitis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Citrobacter bacteraemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Corona virus infection ^† 1	8/200 (4.00%)	10/197 (5.08%)	5/844 (0.59%)	22/3597 (0.61%)
Device related infection ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Diverticulitis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Endocarditis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Enterococcal bacteraemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Escherichia bacteraemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Fungaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Fungal infection ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Gangrene ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pneumonia ^† 1	2/200 (1.00%)	0/197 (0.00%)	6/844 (0.71%)	24/3597 (0.67%)
Pneumonia bacterial ^† 1	0/200 (0.00%)	0/197 (0.00%)	7/844 (0.83%)	4/3597 (0.11%)
Pneumonia haemophilus ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pneumonia pseudomonal ^† 1	0/200 (0.00%)	0/197 (0.00%)	3/844 (0.36%)	0/3597 (0.00%)
Pneumonia staphylococcal ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pneumonia viral ^† 1	3/200 (1.50%)	2/197 (1.02%)	18/844 (2.13%)	22/3597 (0.61%)
Pseudomonal bacteraemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pulmonary sepsis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Sepsis ^† 1	2/200 (1.00%)	1/197 (0.51%)	11/844 (1.30%)	34/3597 (0.95%)
Septic shock ^† 1	2/200 (1.00%)	5/197 (2.54%)	27/844 (3.20%)	52/3597 (1.45%)
Staphylococcal bacteraemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Staphylococcal sepsis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Subcutaneous abscess ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Superinfection ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Superinfection bacterial ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	0/3597 (0.00%)
Thrombophlebitis septic ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Urinary tract infection ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Urinary tract infection bacterial ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Urosepsis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Viral myocarditis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Viral sepsis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Injury, poisoning and procedural complications
Barotrauma ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	3/3597 (0.08%)
Endotracheal intubation complication ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	1/3597 (0.03%)
Fall ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Hip fracture ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Rib fracture ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Subdural haematoma ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Subdural haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	3/3597 (0.08%)
Aspartate aminotransferase increased ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	4/3597 (0.11%)
Bacterial test positive ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Blood alkaline phosphatase increased ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Blood bilirubin increased ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Blood creatinine increased ^† 1	0/200 (0.00%)	0/197 (0.00%)	5/844 (0.59%)	2/3597 (0.06%)
Blood pressure abnormal ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Coma scale abnormal ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Creatinine renal clearance abnormal ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Creatinine renal clearance decreased ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	4/3597 (0.11%)
General physical condition abnormal ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Glomerular filtration rate decreased ^† 1	0/200 (0.00%)	1/197 (0.51%)	1/844 (0.12%)	0/3597 (0.00%)
Haemoglobin decreased ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Hepatic enzyme increased ^† 1	0/200 (0.00%)	1/197 (0.51%)	1/844 (0.12%)	0/3597 (0.00%)
Liver function test increased ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	2/3597 (0.06%)
Myocardial necrosis marker increased ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Oxygen consumption increased ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Oxygen saturation abnormal ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	0/3597 (0.00%)
Oxygen saturation decreased ^† 1	1/200 (0.50%)	0/197 (0.00%)	0/844 (0.00%)	5/3597 (0.14%)
Platelet count decreased ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Transaminases increased ^† 1	3/200 (1.50%)	2/197 (1.02%)	6/844 (0.71%)	3/3597 (0.08%)
Troponin increased ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Urine output decreased ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Metabolism and nutrition disorders
Acidosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Decreased appetite ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Diabetes mellitus ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Diabetic ketoacidosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Fluid overload ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Hyperglycaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Hyperkalaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	2/3597 (0.06%)
Hypernatraemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Hypocalcaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Hypoglycaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Hyponatraemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Hypovolaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Malnutrition ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Metabolic acidosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	1/3597 (0.03%)
Type 2 diabetes mellitus ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Musculoskeletal and connective tissue disorders
Arthritis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Chest wall haematoma ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Compartment syndrome ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	0/3597 (0.00%)
Haematoma muscle ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Muscle haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Musculoskeletal chest pain ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pain in extremity ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Rhabdomyolysis ^† 1	0/200 (0.00%)	0/197 (0.00%)	4/844 (0.47%)	0/3597 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Nervous system disorders
Autonomic nervous system imbalance ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Brain injury ^† 1	0/200 (0.00%)	0/197 (0.00%)	3/844 (0.36%)	1/3597 (0.03%)
Brain oedema ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Cerebellar infarction ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Cerebral haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	3/844 (0.36%)	4/3597 (0.11%)
Cerebral infarction ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	3/3597 (0.08%)
Cerebral microhaemorrhage ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	0/3597 (0.00%)
Cerebrovascular accident ^† 1	0/200 (0.00%)	0/197 (0.00%)	4/844 (0.47%)	7/3597 (0.19%)
Coma ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Dizziness ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Embolic stroke ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Encephalopathy ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	2/3597 (0.06%)
Facial paralysis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Guillain-Barre syndrome ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Haemorrhage intracranial ^† 1	0/200 (0.00%)	0/197 (0.00%)	4/844 (0.47%)	2/3597 (0.06%)
Headache ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Hypoxic-ischaemic encephalopathy ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Iiird nerve disorder ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Ischaemic stroke ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	4/3597 (0.11%)
Lethargy ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Nervous system disorder ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Posterior reversible encephalopathy syndrome ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Seizure ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	3/3597 (0.08%)
Seizure like phenomena ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Syncope ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Thrombotic stroke ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Toxic encephalopathy ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Transient ischaemic attack ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Product Issues
Device dislocation ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Psychiatric disorders
Confusional state ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Delirium ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	0/3597 (0.00%)
Mental status changes ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	10/3597 (0.28%)
Paranoia ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Renal and urinary disorders
Acute kidney injury ^† 1	2/200 (1.00%)	3/197 (1.52%)	50/844 (5.92%)	69/3597 (1.92%)
Anuria ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Azotaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Renal failure ^† 1	1/200 (0.50%)	1/197 (0.51%)	13/844 (1.54%)	17/3597 (0.47%)
Renal impairment ^† 1	0/200 (0.00%)	0/197 (0.00%)	4/844 (0.47%)	1/3597 (0.03%)
Renal tubular necrosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Urinary retention ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Reproductive system and breast disorders
Priapism ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome ^† 1	1/200 (0.50%)	4/197 (2.03%)	23/844 (2.73%)	42/3597 (1.17%)
Acute respiratory failure ^† 1	10/200 (5.00%)	18/197 (9.14%)	36/844 (4.27%)	121/3597 (3.36%)
Aspiration ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Bronchiectasis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Chronic obstructive pulmonary disease ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Dyspnoea ^† 1	4/200 (2.00%)	1/197 (0.51%)	3/844 (0.36%)	26/3597 (0.72%)
Emphysema ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Haemoptysis ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	1/3597 (0.03%)
Haemothorax ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Hypercapnia ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	0/3597 (0.00%)
Hyperoxia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Hypoxia ^† 1	2/200 (1.00%)	4/197 (2.03%)	14/844 (1.66%)	78/3597 (2.17%)
Interstitial lung disease ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Lung opacity ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Pharyngeal haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Pickwickian syndrome ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pleural effusion ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Pneumomediastinum ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	3/3597 (0.08%)
Pneumonia aspiration ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	3/3597 (0.08%)
Pneumonitis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pneumothorax ^† 1	2/200 (1.00%)	4/197 (2.03%)	6/844 (0.71%)	25/3597 (0.70%)
Pneumothorax spontaneous ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Pulmonary embolism ^† 1	1/200 (0.50%)	4/197 (2.03%)	9/844 (1.07%)	32/3597 (0.89%)
Pulmonary oedema ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Pulmonary thrombosis ^† 1	1/200 (0.50%)	0/197 (0.00%)	0/844 (0.00%)	0/3597 (0.00%)
Respiratory acidosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	2/3597 (0.06%)
Respiratory arrest ^† 1	1/200 (0.50%)	0/197 (0.00%)	2/844 (0.24%)	2/3597 (0.06%)
Respiratory disorder ^† 1	1/200 (0.50%)	1/197 (0.51%)	2/844 (0.24%)	22/3597 (0.61%)
Respiratory distress ^† 1	3/200 (1.50%)	5/197 (2.54%)	14/844 (1.66%)	71/3597 (1.97%)
Respiratory failure ^† 1	6/200 (3.00%)	10/197 (5.08%)	59/844 (6.99%)	254/3597 (7.06%)
Respiratory gas exchange disorder ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Respiratory tract haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	0/3597 (0.00%)
Respiratory tract oedema ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Stridor ^† 1	0/200 (0.00%)	0/197 (0.00%)	3/844 (0.36%)	0/3597 (0.00%)
Tachypnoea ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Thoracic haemorrhage ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Skin and subcutaneous tissue disorders
Decubitus ulcer ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Drug eruption ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	0/3597 (0.00%)
Subcutaneous emphysema ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	4/3597 (0.11%)
Social circumstances
Social stay hospitalisation ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Vascular disorders
Arterial thrombosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Circulatory collapse ^† 1	0/200 (0.00%)	0/197 (0.00%)	2/844 (0.24%)	0/3597 (0.00%)
Deep vein thrombosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	6/844 (0.71%)	3/3597 (0.08%)
Distributive shock ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	3/3597 (0.08%)
Dry gangrene ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Embolism ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Haemodynamic instability ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	0/3597 (0.00%)
Hypertension ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Hypotension ^† 1	1/200 (0.50%)	3/197 (1.52%)	23/844 (2.73%)	53/3597 (1.47%)
Hypovolaemic shock ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	3/3597 (0.08%)
Jugular vein thrombosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	2/3597 (0.06%)
Peripheral artery thrombosis ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Peripheral ischaemia ^† 1	0/200 (0.00%)	0/197 (0.00%)	1/844 (0.12%)	1/3597 (0.03%)
Shock ^† 1	0/200 (0.00%)	0/197 (0.00%)	7/844 (0.83%)	11/3597 (0.31%)
Shock haemorrhagic ^† 1	0/200 (0.00%)	1/197 (0.51%)	2/844 (0.24%)	4/3597 (0.11%)
Thrombophlebitis ^† 1	0/200 (0.00%)	0/197 (0.00%)	0/844 (0.00%)	1/3597 (0.03%)
Thrombosis ^† 1	0/200 (0.00%)	1/197 (0.51%)	0/844 (0.00%)	0/3597 (0.00%)
1 Term from vocabulary, MedDRA (22.1) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Part A: Remdesivir (RDV) for 5 Days	Part A: Remdesivir for 10 Days	Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)	Part B: Remdesivir for 10 Days (Extension Group)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	79/200 (39.50%)	92/197 (46.70%)	508/844 (60.19%)	1258/3597 (34.97%)
Blood and lymphatic system disorders
Anaemia ^† 1	7/200 (3.50%)	7/197 (3.55%)	88/844 (10.43%)	104/3597 (2.89%)
Leukocytosis ^† 1	1/200 (0.50%)	1/197 (0.51%)	47/844 (5.57%)	42/3597 (1.17%)
Gastrointestinal disorders
Constipation ^† 1	13/200 (6.50%)	13/197 (6.60%)	78/844 (9.24%)	237/3597 (6.59%)
Diarrhoea ^† 1	10/200 (5.00%)	9/197 (4.57%)	54/844 (6.40%)	128/3597 (3.56%)
Nausea ^† 1	20/200 (10.00%)	17/197 (8.63%)	28/844 (3.32%)	220/3597 (6.12%)
General disorders
Pyrexia ^† 1	9/200 (4.50%)	3/197 (1.52%)	65/844 (7.70%)	101/3597 (2.81%)
Infections and infestations
Pneumonia ^† 1	1/200 (0.50%)	3/197 (1.52%)	48/844 (5.69%)	48/3597 (1.33%)
Investigations
Alanine aminotransferase increased ^† 1	10/200 (5.00%)	15/197 (7.61%)	53/844 (6.28%)	164/3597 (4.56%)
Aspartate aminotransferase increased ^† 1	8/200 (4.00%)	13/197 (6.60%)	66/844 (7.82%)	126/3597 (3.50%)
Transaminases increased ^† 1	3/200 (1.50%)	4/197 (2.03%)	43/844 (5.09%)	93/3597 (2.59%)
Metabolism and nutrition disorders
Hyperglycaemia ^† 1	8/200 (4.00%)	7/197 (3.55%)	62/844 (7.35%)	92/3597 (2.56%)
Hypernatraemia ^† 1	1/200 (0.50%)	2/197 (1.02%)	92/844 (10.90%)	59/3597 (1.64%)
Hypokalaemia ^† 1	10/200 (5.00%)	12/197 (6.09%)	78/844 (9.24%)	190/3597 (5.28%)
Psychiatric disorders
Agitation ^† 1	2/200 (1.00%)	4/197 (2.03%)	74/844 (8.77%)	47/3597 (1.31%)
Delirium ^† 1	2/200 (1.00%)	2/197 (1.02%)	60/844 (7.11%)	40/3597 (1.11%)
Insomnia ^† 1	10/200 (5.00%)	11/197 (5.58%)	17/844 (2.01%)	116/3597 (3.22%)
Renal and urinary disorders
Acute kidney injury ^† 1	2/200 (1.00%)	13/197 (6.60%)	113/844 (13.39%)	117/3597 (3.25%)
Vascular disorders
Deep vein thrombosis ^† 1	4/200 (2.00%)	5/197 (2.54%)	50/844 (5.92%)	55/3597 (1.53%)
Hypertension ^† 1	5/200 (2.50%)	6/197 (3.05%)	92/844 (10.90%)	67/3597 (1.86%)
Hypotension ^† 1	8/200 (4.00%)	9/197 (4.57%)	99/844 (11.73%)	166/3597 (4.61%)
1 Term from vocabulary, MedDRA (22.1) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Gilead Clinical Study Information Center
Organization:	Gilead Sciences
Phone:	1-833-445-3230 (GILEAD-0)
EMail:	GileadClinicalTrials@gilead.com

Publications:

Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, Spinner CD, Galli M, Ahn MY, Nahass RG, Chen YS, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wei X, Gaggar A, Brainard DM, Towner WJ, Munoz J, Mullane KM, Marty FM, Tashima KT, Diaz G, Subramanian A; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020 Nov 5;383(19):1827-1837. doi: 10.1056/NEJMoa2015301. Epub 2020 May 27.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.

Olender SA, Perez KK, Go AS, Balani B, Price-Haywood EG, Shah NS, Wang S, Walunas TL, Swaminathan S, Slim J, Chin B, De Wit S, Ali SM, Soriano Viladomiu A, Robinson P, Gottlieb RL, Tsang TYO, Lee IH, Hu H, Haubrich RH, Chokkalingam AP, Lin L, Zhong L, Bekele BN, Mera-Giler R, Phulpin C, Edgar H, Gallant J, Diaz-Cuervo H, Smith LE, Osinusi AO, Brainard DM, Bernardino JI; GS-US-540-5773 and GS-US-540-5807 Investigators. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care. Clin Infect Dis. 2021 Dec 6;73(11):e4166-e4174. doi: 10.1093/cid/ciaa1041.

Layout table for additonal information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT04292899
Other Study ID Numbers:	GS-US-540-5773 2020-000841-15 ( EudraCT Number ) ISRCTN15874265 ( Other Identifier: ISRCTN )
First Submitted:	February 28, 2020
First Posted:	March 3, 2020
Results First Submitted:	December 15, 2020
Results First Posted:	December 31, 2020
Last Update Posted:	December 31, 2020

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