The National Institute of Allergies and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced this week that the fourth iteration of the COVID-19 Adaptive Treatment Study (ACTT-4) has been closed for registration because of the study met predefined futility criteria indicating that none of the treatment regimens studied is likely to be significantly better than the other.
The NIAID-sponsored study aimed to determine which of the two drug combinations – baricitinib plus remdesivir or dexamethasone plus remdesivir – among others, adults hospitalized with COVID-19 for supplemental oxygen, lead to mechanical ventilation or death could.
An independent data and safety monitoring body (DSMB) overseeing the study met on March 30, 2021 to conduct a planned preliminary efficacy analysis. The DSMB found that neither treatment regimen was significantly better than the other. The study continued and the DSMB met again on April 13, 2021 for a preplanned futility review. The DSMB found that the study is unlikely to show a significant difference between these two arms, even if the study continued to include 1,500 participants.
Therefore, NIAID completed registration on April 13, 2021 with only more than 1,000 participants. The DSMB found that there were no safety issues with either treatment regimen. The study will remain blinded and the investigators will continue to monitor and track those currently being treated according to the protocol.
ACTT-4 participants were randomly assigned to one of two equally sized treatment arms. One group received intravenous (IV) remdesivir, IV dexamethasone, and oral placebo tablets (to mimic baricitinib). The second group received IV remdesivir, baricitinib tablets and an IV placebo (to mimic dexamethasone).
The primary aim of the study is to assess the difference in the proportion of participants who survived without the need for invasive mechanical ventilation between the two treatment arms. The study also aims to compare the overall clinical status on day 15 in each group.
A more detailed report on the test results will be published shortly. For more information on the study, visit ClinicalTrials.gov and search for NCT04640168.
Edited by Gary Cramer