Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: RO7496998; Placebo
Intervention description: 275 mg tablets; Matching tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 216.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Coronavirus Disease 2019; COVID-19; antiviral drug; SARS-CoV-2; Mild to Moderate COVID-19; antiviral efficacy

Summary:

      This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of
      study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent
      participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient
      setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours
             prior to randomization

          -  At least three of the following symptoms of at least moderate (score ≥2 as per
             COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough,
             shortness of breath, muscle or body aches, fatigue, headache, chills or sweats,
             feeling hot or feverish, nausea, vomiting, or diarrhea.

          -  Has symptoms consistent with mild or moderate COVID-19, as determined by the
             investigator, with onset ≤5 days before dosing on Day 1

        Exclusion Criteria:

          -  Clinical signs indicative of COVID-19 illness requiring hospitalization

          -  Admitted to a hospital prior to randomization or is hospitalized (inpatient) at
             randomization due to COVID-19

          -  In the opinion of the investigator, is likely to experience imminent deterioration and
             require hospitalization

          -  Treatment with an investigational drug within 5 half-lives or 3 months (whichever is
             longer) of randomization

          -  Treatment with a COVID-19 therapeutic agent including, but not limited to, other
             direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or
             favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled
             budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal
             antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or
             other EUA-approved treatments within 3 months or less than 5 drug elimination
             half-lives (whichever is longer) prior to the screening visit

          -  Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy
             in the protocol

          -  Known allergy or hypersensitivity to components of study drug

          -  Abnormal laboratory test results at screening

          -  Requirement of any prohibited medications during the study

          -  Other known active viral or bacterial infection at the time of screening, such as
             influenza

          -  Any clinically significant medical condition or laboratory abnormality that, in the
             opinion of the investigator, could jeopardize the safety of the patient or affect
             patient compliance or safety/efficacy observations during the study

          -  COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)