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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
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
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)
Hide 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
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
Hide 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
Hide 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.
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
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)
Hide 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%) 
Hide 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
Hide 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
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
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