STRIVE Trial 2: Immune Modulation Strategy Trial (IM Strategy)
COVID-19 continues to pose significant health challenges, particularly for hospitalised patients. Current guidelines recommend the standard of care (SOC) use of a single immune modulator (IM) in patients who are hospitalised and on low-flow oxygen. Guidelines recommend intensification of immune modulation if a patient has a rapidly progressing need for oxygen support. It is unclear if the use of a second immune modulator early in the disease course for hospitalised patients is beneficial.
This phase IV strategy trial explores the early use of a second immune modulator, abatacept, in hospitalised COVID-19 patients on low-flow oxygen to improve recovery outcomes. By targeting immune dysregulation early, we aim to prevent disease progression and reduce mortality. Our focus is on early intervention with a second immune modulator, differing from current practices that intensify treatment only upon severe progression. The trial aims to recruit 1,500 participants from over 250 participating sites across more than 30 countries.
This is a randomised, double-blinded, placebo-controlled, multi-centre international clinical trial to evaluate the early addition of a second immunomodulator, abatacept, in hospitalised COVID-19 patients on low-flow oxygen.
Participants will be randomly assigned to receive either abatacept plus standard of care or a placebo plus standard of care. The project will evaluate the clinical recovery within 60 days, the occurrence of clinically relevant infections through Day 120, and all-cause mortality through Day 60. An independent data and safety monitoring board will review the trial.
The STRIVE Trial 2 enrolled 285 participants across an international network of clinical sites. The study was stopped early following an administrative funding decision before the planned enrolment target was reached. Results suggested a possible small benefit of abatacept on recovery, but the study was too small to determine this with certainty.
No new or unexpected safety concerns were identified. Study findings have been reported on ClinicalTrials.gov, with publication in a peer-reviewed journal anticipated.
The STRIVE Trial 2 generated valuable international data on the use of abatacept in adults hospitalised with COVID-19. Although the study was unable to provide a definitive answer because it closed early, the findings contribute to the global evidence base on immune modulation strategies for COVID-19 and support the design of future clinical trials for severe respiratory viral infections.
- International Network for Strategic Initiatives in Global HIV Trials
(INSIGHT) - University of Minnesota – Clinical and Translational Science Institute – Minnesota, USA
- Copenhagen HIV Program (CHIP) – Copenhagen, Denmark
- Medical Research Council (MRC) CTU at University College London (UCL) – London, United Kingdom
- The Institute for Clinical Research at the Veterans Affairs Medical Center – Washington, D.C, USA
- Hennepin Medical Center – Minneapolis, Minnesota, USA
- Mount Sinai Medical Center, New York – New York, USA
- Vanderbilt University Medical Center – Nashville, Tennessee, USA
- US Department of Veterans Affairs, USA
- Inserm-ANRS, France
National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
