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Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04292730
Recruitment Status : Completed
First Posted : March 3, 2020
Results First Posted : January 26, 2021
Last Update Posted : January 26, 2021
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 1113
Recruitment Details Participants were enrolled at study sites in the United States, Europe, and Asia. The first participant was screened on 15 March 2020. The last study visit occurred on 26 June 2020.
Pre-assignment Details 1138 participants were screened.
Arm/Group Title Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days
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 received continued SOC therapy. Participants 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 199 197 200 517
Completed 179 176 178 437
Not Completed 20 21 22 80
Reason Not Completed
Lost to Follow-up             8             12             12             48
Death             2             2             4             12
Withdrew Consent             2             2             5             6
Non-Compliance with Study Drug             0             1             0             0
Protocol Violation             0             0             1             0
Randomized but not Treated             8             4             0             14
Arm/Group Title Part A: Remdesivir for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days 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 received continued SOC therapy. Participants 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 191 193 200 503 1087
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 or completed the Day 1 visit (SOC only group). 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 drug.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age, Categorical Number Analyzed 191 participants 193 participants 200 participants 503 participants 1087 participants
< 65 Years 142 141 142 351 776
>= 65 Years 49 52 58 152 311
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 193 participants 200 participants 503 participants 1087 participants
Female 77 75 75 221 448
Male 114 118 125 282 639
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 191 participants 193 participants 200 participants 503 participants 1087 participants
American Indian or Alaska Native 2 0 1 3 6
Asian 34 31 37 61 163
Black 35 37 27 107 206
Native Hawaiian or Pacific Islander 1 1 1 1 4
White 109 107 112 260 588
Not Permitted 5 5 7 21 38
Other 5 12 15 50 82
[1]
Measure Description: Not Permitted means local regulators did not allow collection of race information.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 191 participants 193 participants 200 participants 503 participants 1087 participants
Hispanic or Latino 25 42 34 156 257
Not Hispanic or Latino 162 144 152 325 783
Not Permitted 4 7 13 22 46
Missing 0 0 1 0 1
[1]
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 191 participants 193 participants 200 participants 503 participants 1087 participants
United States 76 99 85 318 578
Spain 37 28 31 44 140
Italy 30 23 26 54 133
United Kingdom 7 9 17 27 60
South Korea 7 4 10 16 37
Germany 8 6 8 13 35
Singapore 3 6 9 14 32
Hong Kong 9 11 7 1 28
Switzerland 4 5 6 3 18
France 2 1 0 5 8
Taiwan 5 1 0 0 6
Netherlands 3 0 1 1 5
Japan 0 0 0 4 4
Sweden 0 0 0 3 3
1.Primary Outcome
Title Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11
Hide Description Clinical status was derived from death, hospital discharge, and 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 available assessment for missing value. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (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 (coronavirus (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 a RDV group relative to the SOC group.
Time Frame Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all participants who were randomized into Part A of the study and received at least 1 dose of study treatment if randomized to 1 of the RDV treatment groups. Participants in the SOC arm who had protocol Day 1 visit were included in the FAS.
Arm/Group Title Part A: Remdesivir for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy
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 received continued SOC therapy.
Overall Number of Participants Analyzed 191 193 200
Measure Type: Number
Unit of Measure: percentage of participants
Score: 1 0.0 1.0 2.0
Score: 2 0.0 0.5 2.0
Score: 3 2.6 0.0 3.5
Score: 4 3.7 6.2 5.5
Score: 5 19.9 22.8 23.0
Score: 6 3.7 4.7 4.0
Score: 7 70.2 64.8 60.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir for 5 Days, Part A: SOC Therapy
Comments Primary analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0174
Comments P-value was calculated using 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 1.65
Confidence Interval (2-Sided) 95%
1.092 to 2.483
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir for 10 Days, Part A: SOC Therapy
Comments Primary analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1826
Comments P-value was calculated using 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 1.31
Confidence Interval (2-Sided) 95%
0.880 to 1.952
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir for 5 Days, Part A: SOC Therapy
Comments Secondary analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0168
Comments P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.
Method Proportional odds model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.65
Confidence Interval (2-Sided) 95%
1.095 to 2.497
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir for 10 Days, Part A: SOC Therapy
Comments Secondary analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2186
Comments P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.
Method Proportional odds model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.862 to 1.917
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Hide Description TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent.
Time Frame First dose date up to last dose date (maximum: 10 days) plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group).
Arm/Group Title Part A: Remdesivir for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy
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 received continued SOC therapy.
Overall Number of Participants Analyzed 191 193 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.3
(44.0 to 58.6)
58.5
(51.3 to 65.6)
46.5
(39.4 to 53.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir for 5 Days, Part A: SOC Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3633
Comments P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
-5.2 to 14.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir for 10 Days, Part A: SOC Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0201
Comments P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
1.6 to 21.8
Estimation Comments [Not Specified]
Time Frame First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) 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 or completed the Day 1 visit (SOC only group); 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 drug.
 
Arm/Group Title Part A: Remdesivir for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, 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. Participants received continued SOC therapy. Participants 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 for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/191 (1.05%)   3/193 (1.55%)   4/200 (2.00%)   13/503 (2.58%) 
Hide Serious Adverse Events
Part A: Remdesivir for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/191 (4.71%)   10/193 (5.18%)   18/200 (9.00%)   40/503 (7.95%) 
Blood and lymphatic system disorders         
Anaemia  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  0/503 (0.00%) 
Febrile neutropenia  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  0/503 (0.00%) 
Pancytopenia  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Thrombocytopenia  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Cardiac disorders         
Atrioventricular block complete  1  0/191 (0.00%)  1/193 (0.52%)  0/200 (0.00%)  0/503 (0.00%) 
Cardiac arrest  1  0/191 (0.00%)  0/193 (0.00%)  2/200 (1.00%)  0/503 (0.00%) 
Cardiac failure acute  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Cardiac failure congestive  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Cardio-respiratory arrest  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Myocardial infarction  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  0/503 (0.00%) 
Gastrointestinal disorders         
Gastrointestinal haemorrhage  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Intestinal ischaemia  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  0/503 (0.00%) 
Intestinal perforation  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Pancreatitis acute  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Small intestinal obstruction  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  2/503 (0.40%) 
Vomiting  1  0/191 (0.00%)  1/193 (0.52%)  0/200 (0.00%)  0/503 (0.00%) 
General disorders         
Chest pain  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  1/503 (0.20%) 
Death  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  2/503 (0.40%) 
General physical health deterioration  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Impaired healing  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  0/503 (0.00%) 
Multiple organ dysfunction syndrome  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  2/503 (0.40%) 
Pyrexia  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Infections and infestations         
Arthritis infective  1  0/191 (0.00%)  1/193 (0.52%)  0/200 (0.00%)  0/503 (0.00%) 
Bacteraemia  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  0/503 (0.00%) 
Biliary sepsis  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Cellulitis  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Corona virus infection  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  2/503 (0.40%) 
Empyema  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Neutropenic sepsis  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Pneumonia  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  1/503 (0.20%) 
Pneumonia bacterial  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  0/503 (0.00%) 
Pneumonia viral  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Sepsis  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Septic shock  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Urinary tract infection  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  2/503 (0.40%) 
Injury, poisoning and procedural complications         
Post procedural bile leak  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Investigations         
Alanine aminotransferase increased  1  0/191 (0.00%)  1/193 (0.52%)  0/200 (0.00%)  0/503 (0.00%) 
Heart rate decreased  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  0/503 (0.00%) 
Metabolism and nutrition disorders         
Fluid overload  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  0/503 (0.00%) 
Hyperkalaemia  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  2/503 (0.40%) 
Cancer pain  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  0/503 (0.00%) 
Lung neoplasm malignant  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Nervous system disorders         
Brain oedema  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Cerebral haemorrhage  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Cerebrovascular accident  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  0/503 (0.00%) 
Depressed level of consciousness  1  0/191 (0.00%)  1/193 (0.52%)  0/200 (0.00%)  0/503 (0.00%) 
Dysarthria  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Syncope  1  0/191 (0.00%)  1/193 (0.52%)  0/200 (0.00%)  0/503 (0.00%) 
Psychiatric disorders         
Agitation  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Confusional state  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Renal and urinary disorders         
Acute kidney injury  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  1/503 (0.20%) 
Renal colic  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  0/503 (0.00%) 
Renal failure  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  2/503 (0.40%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Acute respiratory failure  1  0/191 (0.00%)  1/193 (0.52%)  5/200 (2.50%)  4/503 (0.80%) 
Dyspnoea  1  1/191 (0.52%)  1/193 (0.52%)  0/200 (0.00%)  1/503 (0.20%) 
Epistaxis  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Hypoxia  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Lung opacity  1  0/191 (0.00%)  0/193 (0.00%)  1/200 (0.50%)  0/503 (0.00%) 
Pneumonia aspiration  1  0/191 (0.00%)  1/193 (0.52%)  0/200 (0.00%)  0/503 (0.00%) 
Pneumothorax spontaneous  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
Pulmonary embolism  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  2/503 (0.40%) 
Respiratory distress  1  0/191 (0.00%)  2/193 (1.04%)  2/200 (1.00%)  1/503 (0.20%) 
Respiratory failure  1  1/191 (0.52%)  0/193 (0.00%)  2/200 (1.00%)  1/503 (0.20%) 
Vascular disorders         
Deep vein thrombosis  1  1/191 (0.52%)  0/193 (0.00%)  0/200 (0.00%)  0/503 (0.00%) 
Haemodynamic instability  1  0/191 (0.00%)  1/193 (0.52%)  0/200 (0.00%)  0/503 (0.00%) 
Hypotension  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  2/503 (0.40%) 
Shock  1  0/191 (0.00%)  0/193 (0.00%)  0/200 (0.00%)  1/503 (0.20%) 
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 for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/191 (21.47%)   42/193 (21.76%)   30/200 (15.00%)   113/503 (22.47%) 
Gastrointestinal disorders         
Constipation  1  8/191 (4.19%)  5/193 (2.59%)  9/200 (4.50%)  26/503 (5.17%) 
Diarrhoea  1  12/191 (6.28%)  10/193 (5.18%)  14/200 (7.00%)  28/503 (5.57%) 
Nausea  1  19/191 (9.95%)  18/193 (9.33%)  6/200 (3.00%)  41/503 (8.15%) 
Metabolism and nutrition disorders         
Hypokalaemia  1  10/191 (5.24%)  13/193 (6.74%)  4/200 (2.00%)  23/503 (4.57%) 
Nervous system disorders         
Headache  1  10/191 (5.24%)  10/193 (5.18%)  5/200 (2.50%)  27/503 (5.37%) 
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: NCT04292730    
Other Study ID Numbers: GS-US-540-5774
2020-000842-32 ( EudraCT Number )
ISRCTN85762140 ( Other Identifier: ISRCTN )
First Submitted: February 28, 2020
First Posted: March 3, 2020
Results First Submitted: December 15, 2020
Results First Posted: January 26, 2021
Last Update Posted: January 26, 2021