Clinical trial NCT04501952: Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 584
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Randomization up to Day 28
measure: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
timeFrame: First dose date up to last dose date (maximum: 3 days) plus 30 days
Secondary outcomes:
measure: 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
timeFrame: Randomization up to Day 28
measure: Percentage of Participants Who Died by Day 28
timeFrame: Randomization up to Day 28
measure: Percentage of Participants With COVID-19 Related Hospitalization at Day 28
timeFrame: Randomization up to Day 28
measure: Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14
timeFrame: Randomization up to Day 14
measure: Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14
timeFrame: Randomization up to Day 14
measure: Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7
timeFrame: Baseline up to Day 7
measure: 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)
timeFrame: First Dose Date up to Day 14
measure: Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire
timeFrame: First dose date up to Day 28
measure: Percentage of Participants Who Required Oxygen Supplementation by Day 28
timeFrame: Randomization up to Day 28
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Liver Health
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Trials
state: Arizona
city: Eureka
country: United States
facility: St Joseph Hospital Eureka
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Huntington Beach
country: United States
facility: Elevated Health
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group
state: California
city: Los Angeles
country: United States
facility: LA Universal Center, INC.
state: California
city: Los Angeles
country: United States
facility: Mills Clinical Research
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research
state: California
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Northern California, 6600 Bruceville Road
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Northern California, 2025 Morse Ave
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California, 1200 El Camino Real
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California, 2425 Geary Blvd
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: San Jose
country: United States
facility: Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente Northern California, 2500 Merced St
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Toluca Lake
country: United States
facility: Premiere Medical Center of Burbank, Inc
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Northern California, 975 Sereno Drive
state: California
city: Whittier
country: United States
facility: New Hope Research Development DBA HCD
state: California
city: Denver
country: United States
facility: Centura Health Porter Place
state: Colorado
city: Danbury
country: United States
facility: Nuvance Health
state: Connecticut
city: Boynton Beach
country: United States
facility: RecioMed Clinical Research Network
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinic
state: Florida
city: Fort Pierce
country: United States
facility: Lawnwood Regional Medical Center
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Trials
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Laguna Clinical Research Associates
state: Florida
city: Palm Springs
country: United States
facility: CTMD Research, Inc
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC Inc
state: Florida
city: Pembroke Pines
country: United States
facility: Luminous Clinical Research - South Florida Urgent Care
state: Florida
city: Tampa
country: United States
facility: St. Josephs Comprehensive Research Institute
state: Florida
city: Vero Beach
country: United States
facility: AIDS Research and Treatment Center of the Treasure Coast
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute PA
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials
state: Georgia
city: Macon
country: United States
facility: Mercer University School of Medicine
state: Georgia
city: Burr Ridge
country: United States
facility: Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.
state: Illinois
city: Burr Ridge
country: United States
facility: Metro Infectious Disease Consultants
state: Illinois
city: Chicago
country: United States
facility: NorthStar Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Healthsystem
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: Holy Cross Hospital, Inc.
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: South Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
city: West Roxbury
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Flint
country: United States
facility: Onyx Research Institute
state: Michigan
city: Gulfport
country: United States
facility: Memorial Hospital of Gulfport
state: Mississippi
city: Kansas City
country: United States
facility: Metro Infectious Disease Consultants
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Santa Fe
country: United States
facility: AXCES Research Group
state: New Mexico
city: Flushing
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Huntersville
country: United States
facility: Rosedale Infectious Diseases
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Tahlequah
country: United States
facility: Cherokee Nation WW Hastings Hospital
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Knoxville
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Bellaire
country: United States
facility: UT Physicians
state: Texas
city: College Station
country: United States
facility: Baylor University Medical Center, 700 Scott and White Dr.
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Forney
country: United States
facility: Care United Research, LLC
state: Texas
city: Harlingen
country: United States
facility: VIP Trials
state: Texas
city: Houston
country: United States
facility: University of Texas
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, Inc
state: Texas
city: Irving
country: United States
facility: Baylor University Medical Center, 1901 North McArthur Blvd
state: Texas
city: Laredo
country: United States
facility: Laguna Clinical Research Associates
state: Texas
city: Longview
country: United States
facility: Diagnostic Clinic of Longview - Center for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: STAAMP Research
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice
state: Texas
city: Waco
country: United States
facility: Baylor University Medical Center, 2201 MacArthur Dr., Suite 100
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials
state: Texas
city: Murray
country: United States
facility: Intermountain Healthcare
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Port Orchard
country: United States
facility: Sound Medical Research
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Corporation for Biomedical Research
state: Wisconsin
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Gottlieb RL, Vaca CE, Paredes R, Mera J, Webb BJ, Perez G, Oguchi G, Ryan P, Nielsen BU, Brown M, Hidalgo A, Sachdeva Y, Mittal S, Osiyemi O, Skarbinski J, Juneja K, Hyland RH, Osinusi A, Chen S, Camus G, Abdelghany M, Davies S, Behenna-Renton N, Duff F, Marty FM, Katz MJ, Ginde AA, Brown SM, Schiffer JT, Hill JA; GS-US-540-9012 (PINETREE) Investigators. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2022 Jan 27;386(4):305-315. doi: 10.1056/NEJMoa2116846. Epub 2021 Dec 22.