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

A5207, Maintaining Options for Mothers Study (MOMS): A Phase...

A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to...

Read More

HPTN 069: A Phase II Randomized, Double-Blind, Study of the...

HPTN 069 is a phase II, four-arm, multisite, randomized, double-blinded trial. To assess the safety and tolerability of four...

Read More

A5384: A Phase II, Randomized, Open-Label Trial of a...

Study Description A5384 is a trial for people who have or might have tuberculous meningitis (TBM). TBM is an infectious disease...

Read More

P1073: Study of Immune Reconstitution Inflammatory Syndrome...

P1073 is a case controlled prospective, clinical, observational and pathogenesis study of HIV-infected infants and children...

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