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

• Status: Completed
• Trial end date: 2021-10-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Atea Pharmaceuticals, Inc.

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