Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
Condition: COVID-19
MeSH terms: COVID-19
Intervention: RDV; Placebo to Match RDV
Intervention description: Administered as an intravenous infusion; Administered as an intravenous infusion
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 584.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

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.