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Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
Infectious Diseases COVID-19 Pneumonia COVID-19
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Trial Identifier
NCT04709835, WV43042
Condition
COVID-19
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
Study 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
All
≥18 Years
No
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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com