(Additional Data Sets Released December 2024) ACTIV-1 IM - Immune Modulators for Treating COVID-19

Additional Data Sets Released: The results for ACTIV-1 clinical trial were previously available as three separate STDM datasets, one for each sub-study included in the STDM and ADaM datasets. More data has now been made available for controlled access on accessclinicaldata@NIAID which includes three separate ADaM datasets, one for each sub-study, to allow for additional analysis. With the provision of the ADaM datasets, the final results for this study are now organized between the initial STDM datasets and new ADaM datasets as six separate datasets, two for each sub-study.

The ACTIV-1 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) clinical trial enrolled 1971 patients at 85 sites in the US and Latin America between October 2020 and December 2021. Subjects were randomized to one of the substudies currently active in the study, and then to either the investigational agent (abatacept, infliximab, cenicriviroc) or its matching placebo. The study analyses compared each active therapy against a pooled placebo population consisting of placebo recipients from all three sub-studies (those accrued during the time the sub-study was actively enrolling). The efficacy of each therapeutic agent as add-on therapy to standard of care was evaluated based on the primary endpoint of time to recovery by Day 29. Key secondary objectives of this study were mortality and clinical improvement. Comparisons of the agents among themselves was not a research objective. The cenicriviroc (CVC) sub-study was closed to enrollment on September 3, 2021, due to futility. Evaluations of efficacy also included 8-point Ordinal Scale, incidence, and duration of new oxygen use, and (as an exploratory assessment) National Early Warning Score (NEWS). Safety was evaluated with laboratory and adverse event assessments, as well as evaluations of extrapulmonary manifestations. Blood was collected at select sites for future secondary research. Trial participants were assessed daily while hospitalized through Day 29 or discharge. Outpatient follow-up study visits occurred on Days 8, 11, 15 and 29. Follow up assessments by phone occurred at Days 22 and 60 to assess clinical status and adverse events. The results for this study are available as six separate datasets, two for each sub-study. Enrollment numbers for each sub-study, including the randomization within each sub-study (active vs. matched placebo) and the pooled placebo population for analysis, are as follows: For Abatacept: Active Drug: 524; Matched Placebo: 214; Pooled Placebo (across all sub-studies): 525. For Infliximab: Active Drug: 531; Matched Placebo: 215; Pooled Placebo (across all sub-studies): 530. For CVC: Active Drug: 360; Matched Placebo: 127; Pooled Placebo (across all sub-studies): 363.

ACTIV-1 biospecimen samples may be requested via the ACTIV virtual biorepository page. This is a central web-based virtual biorepository portal that provides a readily searchable systematic inventory of the samples available.