Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
- Registration Number
- NCT04501952
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 584
-
Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures
-
Either:
- Age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant IRB or IEC with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease)
- Or aged ≥ 60 years
-
Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening
-
Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization
-
Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care)
Key
- Participation in any other clinical trial of an experimental treatment and prevention for COVID-19
- Prior hospitalization for COVID-19
- Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine
- Requiring oxygen supplementation
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remdesivir (RDV) 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. Placebo Placebo to Match RDV Participants will receive IV placebo to match (PTM) RDV on Days 1 to 3.
- Primary Outcome Measures
Name Time Method 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 Randomization up to Day 28 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.
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) First dose date up to last dose date (maximum: 3 days) plus 30 days 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.
- Secondary Outcome Measures
Name Time Method 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 Randomization up to Day 28 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.
Percentage of Participants Who Died by Day 28 Randomization up to Day 28 Percentage of Participants With COVID-19 Related Hospitalization at Day 28 Randomization up to Day 28 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.
Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14 Randomization up to Day 14 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.
Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14 Randomization up to Day 14 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-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7 Baseline up to Day 7 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 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) 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). 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.
Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire First dose date up to Day 28 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).
Percentage of Participants Who Required Oxygen Supplementation by Day 28 Randomization up to Day 28
Trial Locations
- Locations (101)
Mills Clinical Research
🇺🇸Los Angeles, California, United States
NorthStar Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland Baltimore
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Texas
🇺🇸Houston, Texas, United States
L&C Professional Medical Research Institute
🇺🇸Miami, Florida, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Kaiser Permanente Northern California, 2425 Geary Blvd
🇺🇸San Francisco, California, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
STAAMP Research
🇺🇸San Antonio, Texas, United States
New York Presbyterian Hospital
🇺🇸Flushing, New York, United States
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Elevated Health
🇺🇸Huntington Beach, California, United States
Evolution Clinical Trials
🇺🇸Hialeah Gardens, Florida, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Laguna Clinical Research Associates
🇺🇸Laredo, Texas, United States
AIDS Research and Treatment Center of the Treasure Coast
🇺🇸Vero Beach, Florida, United States
Luminous Clinical Research - South Florida Urgent Care
🇺🇸Pembroke Pines, Florida, United States
Onyx Research Institute
🇺🇸Flint, Michigan, United States
CTMD Research, Inc
🇺🇸Palm Springs, Florida, United States
IMIC Inc
🇺🇸Palmetto Bay, Florida, United States
Memorial Hospital of Gulfport
🇺🇸Gulfport, Mississippi, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Agile Clinical Research Trials
🇺🇸Atlanta, Georgia, United States
VIP Trials
🇺🇸Harlingen, Texas, United States
Rosedale Infectious Diseases
🇺🇸Huntersville, North Carolina, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The Crofoot Research Center, Inc
🇺🇸Houston, Texas, United States
Quality Clinical Research Inc.
🇺🇸Omaha, Nebraska, United States
AXCES Research Group
🇺🇸Santa Fe, New Mexico, United States
UT Physicians
🇺🇸Bellaire, Texas, United States
Baylor University Medical Center, 700 Scott and White Dr.
🇺🇸College Station, Texas, United States
Holy Cross Hospital, Inc.
🇺🇸Baltimore, Maryland, United States
Nuvance Health
🇺🇸Danbury, Connecticut, United States
Invesclinic
🇺🇸Fort Lauderdale, Florida, United States
RecioMed Clinical Research Network
🇺🇸Boynton Beach, Florida, United States
Ruane Clinical Research Group
🇺🇸Los Angeles, California, United States
Kaiser Permanente Northern California, 1200 El Camino Real
🇺🇸San Francisco, California, United States
Kaiser Permanente Northern California
🇺🇸Oakland, California, United States
New Hope Research Development DBA HCD
🇺🇸Whittier, California, United States
Premiere Medical Center of Burbank, Inc
🇺🇸Toluca Lake, California, United States
Midland Florida Clinical Research Center, LLC
🇺🇸DeLand, Florida, United States
South Shore Hospital
🇺🇸South Weymouth, Massachusetts, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Sugar Lakes Family Practice
🇺🇸Sugar Land, Texas, United States
Baylor University Medical Center, 2201 MacArthur Dr., Suite 100
🇺🇸Waco, Texas, United States
Sound Medical Research
🇺🇸Port Orchard, Washington, United States
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, United Kingdom
Hospital Clinic
🇪🇸Barcelona, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Rigshospitalet
🇩🇰Copenhagen, Denmark
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
St Mary's Hospital
🇬🇧London, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
Cherokee Nation WW Hastings Hospital
🇺🇸Tahlequah, Oklahoma, United States
Arizona Clinical Trials
🇺🇸Tucson, Arizona, United States
Arizona Liver Health
🇺🇸Chandler, Arizona, United States
St Joseph Hospital Eureka
🇺🇸Eureka, California, United States
FOMAT Medical Research
🇺🇸Oxnard, California, United States
Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850
🇺🇸San Jose, California, United States
Kaiser Permanente Northern California, 2500 Merced St
🇺🇸San Leandro, California, United States
Kaiser Permanente Northern California, 975 Sereno Drive
🇺🇸Vallejo, California, United States
Lawnwood Regional Medical Center
🇺🇸Fort Pierce, Florida, United States
Advanced Pulmonary Research Institute
🇺🇸Loxahatchee Groves, Florida, United States
Triple O Research Institute PA
🇺🇸West Palm Beach, Florida, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
NorthShore University Healthsystem
🇺🇸Evanston, Illinois, United States
Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.
🇺🇸Burr Ridge, Illinois, United States
VA Boston Healthcare System
🇺🇸West Roxbury, Massachusetts, United States
Atrium Health Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
University of Tennessee Health Science Center
🇺🇸Knoxville, Tennessee, United States
Care United Research, LLC
🇺🇸Forney, Texas, United States
Baylor University Medical Center, 1901 North McArthur Blvd
🇺🇸Irving, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Diagnostic Clinic of Longview - Center for Clinical Research
🇺🇸Longview, Texas, United States
Intermountain Healthcare
🇺🇸Murray, Utah, United States
ClinPoint Trials
🇺🇸Waxahachie, Texas, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Providence Medical Research Center
🇺🇸Spokane, Washington, United States
University College Hospital
🇬🇧London, United Kingdom
St. Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
LA Universal Center, INC.
🇺🇸Los Angeles, California, United States
UC Davis Health
🇺🇸Sacramento, California, United States
Kaiser Permanente Northern California, 6600 Bruceville Road
🇺🇸Sacramento, California, United States
Kaiser Permanente Northern California, 2025 Morse Ave
🇺🇸Sacramento, California, United States
Centura Health Porter Place
🇺🇸Denver, Colorado, United States
St. Josephs Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Metro Infectious Disease Consultants
🇺🇸Kansas City, Missouri, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Wisconsin Corporation for Biomedical Research
🇺🇸Milwaukee, Wisconsin, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States