ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled
trials using common assessments and endpoints in hospitalized adults diagnosed with
Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with
the intent of identifying promising treatments to enter a more definitive study. The study
will be conducted in up to 70 domestic sites and 5 international sites. The study will
compare different investigational therapeutic agents to a common control arm and determine
which have relatively large effects. In order to maintain the double blind, each intervention
will have a matched placebo. However, the control arm will be shared between interventions
and may include participants receiving the matched placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather
to determine which products have clinical data suggestive of efficacy and should be moved
quickly into larger studies. Estimates produced from BET will provide an improved basis for
designing the larger trial, in terms of sample size and endpoint selection. Products with
little indication of efficacy will be dropped on the basis of interim evaluations. In
addition, some interventions may be discontinued on the basis of interim futility or efficacy
analyses.
One or more interventions may be started at any time. The number of interventions enrolling
are programmatic decisions and will be based on the number of sites and the pace of
enrollment. At the time of enrollment, subjects will be randomized to receive any one of the
active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared
placebo) subjects will be assigned to each arm entering the platform and a given site will
generally have no more than 3 interventions at once.
The BET-A stage will evaluate the combination of remdesivir with risankizumab vs remdesivir
with a risankizumab placebo. The primary objective is to evaluate the clinical efficacy of
different investigational therapeutics relative to the control arm in adults hospitalized
with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)