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

A5349: Rifapentine-containing treatment shortening regimens...

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a...

Read More

A5332: Randomized Trial to Prevent Vascular Events in HIV...

REPRIEVE (A5332) is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months....

Read More

A5361s: Pitavastatin to REduce Physical Function Impairment...

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants...

Read More

HPTN083: A Phase 2b/3 Double Blind Safety and Efficacy Study...

HPTN 083 is a study being done to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for...

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