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.
We expect that early immunomodulator intensification with abatacept will improve recovery outcomes, reduce mortality, shorten the time to recovery, and decrease the need for intensive care for hospitalized COVID-19 patients on low-flow oxygen. The trial will provide comprehensive data on the efficacy and safety of early use of a second immune modulator in this patient population.
This project aims to enhance COVID-19 treatment by showing that early use of abatacept improves recovery and reduces mortality. This strategy could change
COVID-19 treatment guidelines, offering timely and effective management, and providing crucial insights into the clinical management of immunocompromised patients.
- 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)
