Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: AT-527; Placebo
Intervention description: Results from Arm AT-527 500 mg determined the dose and regimen to be used for AT-527 1100 mg.; The dose and regimen of the placebo will match that of the respective AT-527 comparator arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized study evaluates the antiviral activity, safety, efficacy and pharmacokinetics
      of AT-527 versus a placebo in participants with mild or moderate coronavirus disease
      (COVID-19) who are not hospitalized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test)at screening

          -  Has symptoms consistent with mild or moderate COVID-19, as determined by the
             investigator, with onset ≤5 days prior to randomization

        Exclusion Criteria:

          -  Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as
             any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate
             ≥125, peripheral capillary oxygen saturation ≤93% on room air

          -  Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to,
             other direct acting antivirals, convalescent plasma, monoclonal antibodies against
             SARS CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug
             elimination half-lives (whichever is longer) prior to screening

          -  Requirement, in the opinion of the investigator, for any of the prohibited medications
             during the study

          -  Use of hydroxychloroquine or amiodarone within 3 months of screening

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             30 days after the final dose of AT-527. Women of childbearing potential must have a
             negative urine pregnancy test result at screening

          -  Abnormal laboratory test results at screening

          -  Clinically significant abnormal ECG, as determined by the Investigator, at screening

          -  Planned procedure or surgery during the study

          -  Known allergy or hypersensitivity to study drug or drug product excipients

          -  Substance abuse, as determined by the investigator, within 12 months prior to
             screening

          -  Poor peripheral venous access

          -  Malabsorption syndrome or other condition that would interfere with enteral absorption

          -  Any clinically significant history of epistaxis within the last 3 months and/or
             history of being hospitalized due to epistaxis of any previous occasion

          -  History of anaphylaxis

          -  Any uncontrolled serious medical condition or other clinically significant abnormality
             in clinical laboratory tests that, in the investigator's judgment, precludes the
             patient's safe participation in and completion of the study