Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19

• Status: Suspended
• Trial end date: 2021-11-17
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization

• At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea.

• Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1

Exclusion Criteria:

• Clinical signs indicative of COVID-19 illness requiring hospitalization

• Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19

• In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization

• Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization

• Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit

• Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol

• Known allergy or hypersensitivity to components of study drug

• Abnormal laboratory test results at screening

• Requirement of any prohibited medications during the study

• Other known active viral or bacterial infection at the time of screening, such as influenza

• Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study

• COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)