Closed to accrual
A5401: ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies
A master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. It begins with a phase II evaluation, followed by a transition into a larger phase III evaluation for promising agents.
To rapidly and efficiently evaluate multiple potential therapeutics for COVID-19 in an outpatient setting.
- Ambulatory Adult (18 years or older)
- Active SARS-CoV-2 infection <7 days prior to Entry
- At least one typical COVID-19 symptom for <10 days prior to Entry, plus one the following symptoms present within 48 hours of entry:
–Fever or feeling feverish, cough, shortness of breath at rest or with activity, sore throat, body or muscle pain, fatigue, headache, chills
- Tailored per study agent requirements
Duration Of Study
28 days of intensive follow-up, followed by limited follow-up through 24 weeks.