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Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting

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ClinicalTrials.gov Identifier: NCT04501952
Recruitment Status : Terminated (The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.)
First Posted : August 6, 2020
Results First Posted : November 16, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: RDV
Drug: Placebo to Match RDV
Enrollment 584
Recruitment Details Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 18 September 2020. The last study visit occurred on 06 May 2021.
Pre-assignment Details 630 participants were screened.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description Participants received a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. Participants received IV placebo to match (PTM) RDV on Days 1 to 3.
Period Title: Overall Study
Started 292 292
Completed 266 272
Not Completed 26 20
Reason Not Completed
Adverse Event             0             3
Investigator's Discretion             0             1
Protocol Violation             1             1
Withdrew Consent             5             4
Lost to Follow-up             7             2
Randomized and Never Treated             13             9
Arm/Group Title Remdesivir Placebo Total
Hide Arm/Group Description Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. Participants received IV PTM RDV on Days 1 to 3. Total of all reporting groups
Overall Number of Baseline Participants 279 283 562
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 279 participants 283 participants 562 participants
50  (15.3) 51  (14.8) 50  (15.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants 283 participants 562 participants
Female
131
  47.0%
138
  48.8%
269
  47.9%
Male
148
  53.0%
145
  51.2%
293
  52.1%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 279 participants 283 participants 562 participants
American Indian or Alaska Native
15
   5.4%
21
   7.4%
36
   6.4%
Asian
6
   2.2%
7
   2.5%
13
   2.3%
Black
20
   7.2%
22
   7.8%
42
   7.5%
Native Hawaiian or Pacific Islander
1
   0.4%
0
   0.0%
1
   0.2%
White
228
  81.7%
224
  79.2%
452
  80.4%
Other
3
   1.1%
2
   0.7%
5
   0.9%
Not Permitted
6
   2.2%
7
   2.5%
13
   2.3%
[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 279 participants 283 participants 562 participants
Hispanic or Latino
123
  44.1%
112
  39.6%
235
  41.8%
Not Hispanic or Latino
146
  52.3%
158
  55.8%
304
  54.1%
Not Permitted
10
   3.6%
13
   4.6%
23
   4.1%
[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 279 participants 283 participants 562 participants
United States
264
  94.6%
267
  94.3%
531
  94.5%
Denmark
5
   1.8%
5
   1.8%
10
   1.8%
United Kingdom
3
   1.1%
1
   0.4%
4
   0.7%
Spain
7
   2.5%
10
   3.5%
17
   3.0%
1.Primary Outcome
Title Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28
Hide Description The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time Frame Randomization up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 279 283
Measure Type: Number
Unit of Measure: percentage of participants
0.7 5.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0076
Comments [Not Specified]
Method Regression, Cox
Comments P-value was estimated using the Cox regression with baseline stratification factors as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.134
Confidence Interval (2-Sided) 95%
0.031 to 0.586
Estimation Comments Hazard ratio and two-sided 95% confidence interval (CI) were estimated using the Cox regression with baseline stratification factors as covariates.
2.Primary Outcome
Title Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Hide Description TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
Time Frame First dose date up to last dose date (maximum: 3 days) plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 279 283
Measure Type: Number
Unit of Measure: percentage of participants
42.3 46.3
3.Secondary Outcome
Title Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28
Hide Description The composite outcome of COVID-19 related MAVs or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time Frame Randomization up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Set included all participants who were randomized into the study, and received at least 1 dose of study treatment, and enrolled under protocol amendment 2 or later.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 246 252
Measure Type: Number
Unit of Measure: percentage of participants
1.7 8.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Regression, Cox
Comments P-value was estimated using the Cox regression with baseline stratification factors as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.191
Confidence Interval (2-Sided) 95%
0.065 to 0.555
Estimation Comments Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.
4.Secondary Outcome
Title Percentage of Participants Who Died by Day 28
Hide Description [Not Specified]
Time Frame Randomization up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 266 274
Measure Type: Number
Unit of Measure: percentage of participants
0 0
5.Secondary Outcome
Title Percentage of Participants With COVID-19 Related Hospitalization at Day 28
Hide Description COVID-19 related hospitalization is defined as at least 24 hours of acute care derived by COVID-19 related hospitalization reported by the site. The percentage of the outcome and the corresponding 95% confidence interval were from Kaplan-Meier estimate.
Time Frame Randomization up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 279 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.7
(0.2 to 2.9)
5.4
(3.3 to 8.7)
6.Secondary Outcome
Title Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14
Hide Description The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time Frame Randomization up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 279 283
Measure Type: Number
Unit of Measure: percentage of participants
0.7 5.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0076
Comments [Not Specified]
Method Regression, Cox
Comments P-value were estimated using the Cox regression with baseline stratification factors as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.134
Confidence Interval (2-Sided) 95%
0.031 to 0.586
Estimation Comments Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.
7.Secondary Outcome
Title Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14
Hide Description The composite outcome of COVID-19 related MAVs or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time Frame Randomization up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the modified Full Analysis Set were analyzed.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 246 252
Measure Type: Number
Unit of Measure: percentage of participants
0.8 8.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Regression, Cox
Comments P-value were estimated using the Cox regression with baseline stratification factors as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.100
Confidence Interval (2-Sided) 95%
0.023 to 0.430
Estimation Comments Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.
8.Secondary Outcome
Title Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7
Hide Description The time-weighted average change from baseline to study Day 7 (DAVG7) in SARS-CoV-2 viral load is defined as the time-weighted average between the first postbaseline value through the last available value up to Day 7 minus the baseline value in SARS-CoV-2 viral load (log10 copies/mL). DAVG7 is calculated using the trapezoidal rule and the area under the curve (AUC). For participants with data through days prior to Day 7, the time-weighted average change used data up to last available timepoint. If there was no postbaseline data, the participant was excluded from the analysis.
Time Frame Baseline up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Virology Analysis Set (all the participants who were randomized into the study, received at least 1 dose of study treatment, and had positive SARS-CoV-2 viral load at baseline) with available data were analyzed.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 211 208
Mean (Standard Deviation)
Unit of Measure: log10 copies/ mililiter (mL)
-1.24  (1.123) -1.14  (1.099)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4318
Comments [Not Specified]
Method ANCOVA
Comments P-value were from an ANCOVA model with baseline viral load as a covariate.
Method of Estimation Estimation Parameter Least Squares Mean
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.10 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments Least squares Mean (LSM), standard error (SE) and 95% CI were from an ANCOVA model with baseline viral load as a covariate.
9.Secondary Outcome
Title Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted Influenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus)
Hide Description The COVID-19-adapted FLU-PRO Plus is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). Time to alleviation of baseline COVID-19 symptoms is defined (in days) as: First Date of the two consecutive dates achieving alleviation - First dose Date + 1. If a participant had not achieved symptom alleviation at last FLU-PRO Plus assessment or early discontinuation of study, the participant was censored at last FLU-PRO Plus assessment date.
Time Frame First Dose Date up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV placebo to match RDV on Days 1 to 3.
Overall Number of Participants Analyzed 66 60
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(10.0 to NA)
NA [1] 
(13.0 to NA)
[1]
Not enough event to estimate Median and Inter-Quartile Range
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2987
Comments [Not Specified]
Method Log Rank
Comments p-value was based on stratified log-rank test with baseline stratification factor as strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.405
Confidence Interval (2-Sided) 95%
0.733 to 2.693
Estimation Comments Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.
10.Secondary Outcome
Title Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire
Hide Description The worsening after alleviation of baseline COVID-19 symptoms is defined as for a participant who has achieved alleviation of baseline COVID-19 symptoms, if symptom scored as 2 or higher at baseline is scored as 2 or higher postbaseline after achieved alleviation, or symptoms scored as 1 at baseline are scored as 1 or higher postbaseline after achieved alleviation. The COVID-19-adapted FLU-PRO Plus was used. It is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild).
Time Frame First dose date up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 23 15
Measure Type: Number
Unit of Measure: percentage of participants
30.4 13.3
11.Secondary Outcome
Title Percentage of Participants Who Required Oxygen Supplementation by Day 28
Hide Description [Not Specified]
Time Frame Randomization up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description:
Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Participants received IV PTM RDV on Days 1 to 3.
Overall Number of Participants Analyzed 279 283
Measure Type: Number
Unit of Measure: percentage of participants
0.4 1.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2163
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Adverse Events: First dose date up to 3 days plus 30 days; All-Cause Mortality: Randomization to the end of study (maximum: 59 days)
Adverse Event Reporting Description Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
 
Arm/Group Title Remdesivir Placebo
Hide Arm/Group Description Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3. Participants received IV PTM RDV on Days 1 to 3.
All-Cause Mortality
Remdesivir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/292 (0.00%)   1/292 (0.34%) 
Hide Serious Adverse Events
Remdesivir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/279 (1.79%)   19/283 (6.71%) 
Cardiac disorders     
Acute myocardial infarction † 1  0/279 (0.00%)  1/283 (0.35%) 
Angina pectoris † 1  1/279 (0.36%)  1/283 (0.35%) 
Atrial fibrillation † 1  2/279 (0.72%)  0/283 (0.00%) 
Cardiac failure congestive † 1  1/279 (0.36%)  0/283 (0.00%) 
Mitral valve prolapse † 1  0/279 (0.00%)  1/283 (0.35%) 
Infections and infestations     
Covid-19 † 1  1/279 (0.36%)  2/283 (0.71%) 
Covid-19 pneumonia † 1  0/279 (0.00%)  7/283 (2.47%) 
Pneumonia † 1  2/279 (0.72%)  3/283 (1.06%) 
Viral myocarditis † 1  1/279 (0.36%)  0/283 (0.00%) 
Injury, poisoning and procedural complications     
Lumbar vertebral fracture † 1  0/279 (0.00%)  1/283 (0.35%) 
Road traffic accident † 1  0/279 (0.00%)  1/283 (0.35%) 
Investigations     
Fibrin D dimer increased † 1  0/279 (0.00%)  1/283 (0.35%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain † 1  0/279 (0.00%)  1/283 (0.35%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure † 1  0/279 (0.00%)  1/283 (0.35%) 
Dyspnoea † 1  0/279 (0.00%)  1/283 (0.35%) 
Hypoxia † 1  0/279 (0.00%)  3/283 (1.06%) 
Pulmonary embolism † 1  0/279 (0.00%)  1/283 (0.35%) 
Respiratory failure † 1  1/279 (0.36%)  1/283 (0.35%) 
Vascular disorders     
Blood pressure inadequately controlled † 1  1/279 (0.36%)  0/283 (0.00%) 
1
Term from vocabulary, MedDRA (24.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Remdesivir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   48/279 (17.20%)   49/283 (17.31%) 
Gastrointestinal disorders     
Nausea † 1  30/279 (10.75%)  21/283 (7.42%) 
Nervous system disorders     
Headache † 1  16/279 (5.73%)  17/283 (6.01%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  10/279 (3.58%)  18/283 (6.36%) 
1
Term from vocabulary, MedDRA (24.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04501952    
Other Study ID Numbers: GS-US-540-9012
2020-003510-12 ( EudraCT Number )
First Submitted: August 5, 2020
First Posted: August 6, 2020
Results First Submitted: November 4, 2021
Results First Posted: November 16, 2021
Last Update Posted: November 16, 2021