A5401: ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies

Closed to accrual

A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)

Treatment Category

COVID-19 and Mpox

Study Description

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.

Study Purpose

To rapidly and efficiently evaluate multiple potential therapeutics for COVID-19 in an outpatient setting.

Target Participant

  • 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.

More Info

To find more information click here and to see our press release relating to this study click here.