A Phase III study to evaluate the Efficacy, Safety, and Antiviral Activity of RO7496998 (AT-527) in Non-hospitalized Patients with Mild or Moderate COVID-19
- Conditions
- SARS-COV-2 infection
- Registration Number
- JPRN-jRCT2031210070
- Lead Sponsor
- Rebecca Saenz, M.D., Ph.D.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1386
Age >=18 years (regardless of weight) or age >=12 to <18 under (weight >=40 kg ) at the time of signing informed consent (and assent)
- 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
- Positive SARS-CoV-2 diagnostic test withoin72 hours prior to randomization
- Symptoms consistent with mild or moderate COVID-19 with onset within 5 days before randomization
- For women of childbearing potential: agreement to remain abstinent or use adequate contraception during the study duration
- Admitted to a hospital prior to randomization at randomization due to COVID-19
- Is likely to experience imminent deterioration and require hospitalization
- Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
- Treatment with a COVID-19 therapeutic agent against SARS-CoV-2 within the last 2 weeks prior to the screening visit
- Concomitant use of P-glycoprotein inhibitors or inducers
- Abnormal laboratory test results at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method