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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 : Active, not recruiting
First Posted : August 6, 2020
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
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.

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 ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: RDV
Administered as an intravenous infusion
Other Names:
  • GS-5734™
  • Veklury®

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




Primary Outcome Measures :
  1. 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 ]
  2. Proportion of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: From date of randomization up to 3 days plus 30 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. All-cause Mortality at Day 28 [ Time Frame: Day 28 ]
  3. Rate of Hospitalization by Day 28 [ Time Frame: Day 28 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  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).


  8. Proportion of Participants Progressing to Requiring Oxygen Supplementation by Day 28 [ Time Frame: From date of randomization up to Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • SARS-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.


Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04501952    
Other Study ID Numbers: GS-US-540-9012
2020-003510-12 ( EudraCT Number )
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No