Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19

  • COVID-19 Pneumonia
Trial Status:

Completed

This trial runs in
Countries
  • Bulgaria
  • Canada
  • Greece
  • Ireland
  • Latvia
  • Lithuania
  • Poland
  • Spain
  • United Kingdom
Trial Identifier:

NCT04709835 WV43042

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04709835 , WV43042 Trial Identifier
      AT-527, Placebo Treatments
      COVID-19 Condition
      Official Title

      A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

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