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.
Drug: AT-527
Results from Arm AT-527 500 mg determined the dose and regimen to be used for AT-527 1100 mg.
Other Name: RO7496998
Drug: Placebo
The dose and regimen of the placebo will match that of the respective AT-527 comparator arm.
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
Hamilton Medical Research Group
Hamilton, Ontario, Canada
National and Kapodistrian University of Athens
Athens, Greece
General State Hospital of Nikaia St Panteleimon
Nikaia Attikis, Greece
Connolly Hospital
Dublin, Ireland
Outpatient Clinic Adoria
Rīga, Latvia
The Family Physician's Practice of Dr. Maija Kozlovska
Salaspils, Latvia
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Chapel Street Medical Centre
Ashton-under-Lyne, United Kingdom
Tower Family Healthcare - Moorgate Primary Care Ce
Bury, United Kingdom
CPS Research
Glasgow, United Kingdom
Chelsea and Westminster NHS Trust
London, United Kingdom
Clinical Trials, Study Director
Hoffmann-La Roche