NCT IdNCT04280705
TitleAdaptive COVID-19 Treatment Trial
ConditionCorona Virus COVID-19
OrganizationNational Institute of Allergy and Infectious Diseases (NIAID)
Sponsor/CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
Location Multiple Sites
DescriptionThis study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to 50 sites globally. The study will be a series of 2-arm comparisons between different investigational therapeutic agents and a placebo. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, this treatment will then become the control arm for comparison(s) with new experimental treatment(s). Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. Randomization will be stratified by: 1) site and 2) severity of illness at enrollment, severe disease (requiring mechanical ventilation or oxygen, a SpO2 </= 94% or tachypnea (respiratory rate >/= 24 breaths/min)) or mild-moderate disease (SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen)). Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15, and 29. All subjects will undergo a series of efficacy, safety, and laboratory assessments. The primary objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19.