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 : Recruiting
First Posted : August 6, 2020
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: RDV Drug: Placebo to Match RDV||Phase 3|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting|
|Actual Study Start Date :||September 18, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Remdesivir (RDV)
Participants will receive a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Administered as an intravenous infusion
Placebo Comparator: Placebo
Participants will receive IV placebo to match (PTM) RDV on Days 1 to 3.
Drug: Placebo to Match RDV
Administered as an intravenous infusion
- Composite Endpoint of Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-cause Death by Day 28. [ Time Frame: From date of randomization up to Day 28 ]
- Proportion of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: From date of randomization up to 3 days plus 30 days ]
- Composite Endpoint of COVID-19 Related MAVs (Medical Visits Attended in Person by the Participant and a Health Care Professional) or All-cause Death by Day 28 [ Time Frame: From date of randomization up to Day 28 ]
- All-cause Mortality at Day 28 [ Time Frame: Day 28 ]
- Rate of Hospitalization by Day 28 [ Time Frame: Day 28 ]
- Composite Endpoint of COVID-19 Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-cause Death by Day 14 [ Time Frame: From date of randomization up to Day 14 ]
- Composite Endpoint of COVID-19 Related MAVs (Medical Visits Attended in Person by the Participant and a Health Care Professional) or All-cause Death by Day 14 [ Time Frame: From date of randomization up to Day 14 ]
- Time-weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load from Baseline to Day 7 [ Time Frame: Baseline; Day 7 ]
- Time to Alleviation (Mild or Absent) of Baseline Coronavirus Disease 2019 (COVID-19) Symptoms as Reported on the COVID-19-adapted InFLUenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus) [ Time Frame: First Dose Date Up to Day 14 ]
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).
- Proportion of Participants Progressing to Requiring Oxygen Supplementation by Day 28 [ Time Frame: From date of randomization up to Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501952
|Contact: Gilead Clinical Study Information Center||1-833-445-3230 (GILEAD-0)||GileadClinicalTrials@gilead.com|
|Study Director:||Gilead Study Director||Gilead Sciences|