ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients with COVID-19 (Adapt Out COVID)

Study Location:

BaltimoreIndia

Topic:

Enrollment:

Open

Trial Period:

Ongoing

Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease progression, and reduce serious complications of COVID-19 and transmission [10]. ACTIV-2/A5401 is a phase II/III randomized, blinded, controlled adaptive platform trial to efficiently evaluate agents for the treatment of non-hospitalized persons with COVID-19. This will allow: 

  • • comparison of multiple therapies with a common control group, when feasible, thus potentially requiring fewer participants than in independently conducted randomized controlled trials, 
  • • continuous introduction of new promising agents as they become available, 
  • • generation of separate effect size estimates for each therapy, and 
  • • minimized downtime, with rapid movement of promising agents into phase III evaluation. 

Additionally, the trial will facilitate the exploration of virologic endpoints as possible future primary endpoints in COVID-19 trials by assessing the correlation between changes in viral shedding and clinical outcomes. 

Adults

Categories

Location
Topic

Clinical Trials

ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients...

Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease...

Read More

P1077BF: Breastfeeding Version of the PROMISE Study...

1077BF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting...

Read More

A5342: Evaluating the Safety, Tolerability, and Effect of a...

The purpose of this study is to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody...

Read More

P2026: Pharmacokinetic Properties of Antiretroviral and...

IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women,...

Read More

A5350: Effects of Visbiome Extra Strength on Gut Microbiome...

Many factors contribute to the development of aging-related conditions, including gastrointestinal (GI) diseases, such as...

Read More