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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04501952
• Other study ID #: GS-US-540-9012
• Secondary ID: 2020-003510-12
• Status: Terminated
• Phase: Phase 3
• Start date: September 18, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: November 2021
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 584
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• RDV
Administered as an intravenous infusion
• Placebo to Match RDV
Administered as an intravenous infusion

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Rigshospitalet	Copenhagen
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense University Hospital	Odense
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Clinic	Barcelona
Spain	Hospital Universitario Infanta Leonor	Madrid
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford
United Kingdom	St Mary's Hospital	London
United Kingdom	University College Hospital	London
United Kingdom	Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne
United States	Agile Clinical Research Trials	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	Holy Cross Hospital, Inc.	Baltimore	Maryland
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	UT Physicians	Bellaire	Texas
United States	Be Well Medical Center	Berkley	Michigan
United States	Tufts Medical Center	Boston	Massachusetts
United States	RecioMed Clinical Research Network	Boynton Beach	Florida
United States	Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.	Burr Ridge	Illinois
United States	Metro Infectious Disease Consultants	Burr Ridge	Illinois
United States	Arizona Liver Health	Chandler	Arizona
United States	Atrium Health Carolinas Medical Center	Charlotte	North Carolina
United States	NorthStar Medical Center	Chicago	Illinois
United States	Christ Hospital	Cincinnati	Ohio
United States	Baylor University Medical Center, 700 Scott and White Dr.	College Station	Texas
United States	Baylor University Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Nuvance Health	Danbury	Connecticut
United States	Midland Florida Clinical Research Center, LLC	DeLand	Florida
United States	Centura Health Porter Place	Denver	Colorado
United States	St Joseph Hospital Eureka	Eureka	California
United States	NorthShore University Healthsystem	Evanston	Illinois
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Onyx Research Institute	Flint	Michigan
United States	New York Presbyterian Hospital	Flushing	New York
United States	Care United Research, LLC	Forney	Texas
United States	Invesclinic	Fort Lauderdale	Florida
United States	Lawnwood Regional Medical Center	Fort Pierce	Florida
United States	St. Joseph Heritage Healthcare	Fullerton	California
United States	East Carolina University	Greenville	North Carolina
United States	Memorial Hospital of Gulfport	Gulfport	Mississippi
United States	VIP Trials	Harlingen	Texas
United States	Evolution Clinical Trials	Hialeah Gardens	Florida
United States	Encore Medical Research	Hollywood	Florida
United States	The Crofoot Research Center, Inc	Houston	Texas
United States	University of Texas	Houston	Texas
United States	Rosedale Infectious Diseases	Huntersville	North Carolina
United States	Elevated Health	Huntington Beach	California
United States	Baylor University Medical Center, 1901 North McArthur Blvd	Irving	Texas
United States	Metro Infectious Disease Consultants	Kansas City	Missouri
United States	University of Tennessee Health Science Center	Knoxville	Tennessee
United States	Laguna Clinical Research Associates	Laredo	Texas
United States	AB Clinical Trials	Las Vegas	Nevada
United States	Diagnostic Clinic of Longview - Center for Clinical Research	Longview	Texas
United States	LA Universal Center, INC.	Los Angeles	California
United States	Mills Clinical Research	Los Angeles	California
United States	Ruane Clinical Research Group	Los Angeles	California
United States	Advanced Pulmonary Research Institute	Loxahatchee Groves	Florida
United States	Mercer University School of Medicine	Macon	Georgia
United States	L&C Professional Medical Research Institute	Miami	Florida
United States	Laguna Clinical Research Associates	Miami	Florida
United States	Wisconsin Corporation for Biomedical Research	Milwaukee	Wisconsin
United States	Intermountain Healthcare	Murray	Utah
United States	Northwell Health	New Hyde Park	New York
United States	Tulane University	New Orleans	Louisiana
United States	Kaiser Permanente Northern California	Oakland	California
United States	Quality Clinical Research Inc.	Omaha	Nebraska
United States	FOMAT Medical Research	Oxnard	California
United States	CTMD Research, Inc	Palm Springs	Florida
United States	IMIC Inc	Palmetto Bay	Florida
United States	Luminous Clinical Research - South Florida Urgent Care	Pembroke Pines	Florida
United States	Temple University	Philadelphia	Pennsylvania
United States	Sound Medical Research	Port Orchard	Washington
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Kaiser Permanente Northern California, 2025 Morse Ave	Sacramento	California
United States	Kaiser Permanente Northern California, 6600 Bruceville Road	Sacramento	California
United States	UC Davis Health	Sacramento	California
United States	STAAMP Research	San Antonio	Texas
United States	Kaiser Permanente Northern California, 1200 El Camino Real	San Francisco	California
United States	Kaiser Permanente Northern California, 2425 Geary Blvd	San Francisco	California
United States	UCSF Medical Center	San Francisco	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	AXCES Research Group	Santa Fe	New Mexico
United States	St. Joseph Heritage Healthcare	Santa Rosa	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	South Shore Hospital	South Weymouth	Massachusetts
United States	Providence Medical Research Center	Spokane	Washington
United States	Sugar Lakes Family Practice	Sugar Land	Texas
United States	Cherokee Nation WW Hastings Hospital	Tahlequah	Oklahoma
United States	St. Josephs Comprehensive Research Institute	Tampa	Florida
United States	Premiere Medical Center of Burbank, Inc	Toluca Lake	California
United States	Arizona Clinical Trials	Tucson	Arizona
United States	Kaiser Permanente Northern California, 975 Sereno Drive	Vallejo	California
United States	AIDS Research and Treatment Center of the Treasure Coast	Vero Beach	Florida
United States	Baylor University Medical Center, 2201 MacArthur Dr., Suite 100	Waco	Texas
United States	ClinPoint Trials	Waxahachie	Texas
United States	Triple O Research Institute PA	West Palm Beach	Florida
United States	VA Boston Healthcare System	West Roxbury	Massachusetts
United States	New Hope Research Development DBA HCD	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Denmark,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Randomization up to Day 28
Primary	Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)	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.	First dose date up to last dose date (maximum: 3 days) plus 30 days
Secondary	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	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.	Randomization up to Day 28
Secondary	Percentage of Participants Who Died by Day 28		Randomization up to Day 28
Secondary	Percentage of Participants With COVID-19 Related Hospitalization at 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.	Randomization up to Day 28
Secondary	Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by 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.	Randomization up to Day 14
Secondary	Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by 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.	Randomization up to Day 14
Secondary	Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline 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.	Baseline up to Day 7
Secondary	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)	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.	First Dose Date up to Day 14
Secondary	Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire	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).	First dose date up to Day 28
Secondary	Percentage of Participants Who Required Oxygen Supplementation by Day 28		Randomization up to Day 28