STRIVE Trial 1: Shionogi Protease Inhibitor (S-217622)
Outcomes among hospitalised patients infected with SARS-CoV-2, including and especially those with critical disease, remain poor. Given the ongoing clinical need for improved treatments for hospitalised patients and the evidence for ongoing viral replication in this cohort, new antiviral agents, including direct-acting antivirals (DAA), are an important priority for additional investigation.
This COVID-19 treatment study is designed to evaluate the safety and efficacy of S-217622, an anti-SARS-CoV-2 3C-like protease inhibitor developed by Shionogi & Co. Ltd. S-217622 (ensitrelvir), when given in addition to standard of care in patients hospitalised for the medical management of COVID-19. By potentially reducing mortality and recovery times, the project aims to offer a new, effective treatment option, significantly impacting patient outcomes for hospitalised patients with COVID-19 symptoms. This large-scale study plans to recruit 1,500 participants at over 250 sites across more than 30 countries.
This is a phase III, randomised, double-blinded, placebo-controlled, multi-centre international clinical trial. Randomisation to S-217622 plus SOC or matched placebo plus SOC will be in a 1:1 allocation. The study investigational agent/placebo will be administered as oral tablets for five days. All participants will receive the full 5-day course, including those who are discharged from hospitalisation prior to Day 4. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomisation. An independent data and safety monitoring board will regularly review interim safety and efficacy data of this trial.
This study aims to demonstrate the effectiveness of S-217622 in treating hospitalised COVID-19 patients. Key expected outcomes include faster recovery times and reduced mortality rates. The trial is designed to assess the drug's ability to decrease the severity of illness by Day 60. Interim analyses at various stages will provide insights into the drug's efficacy and safety, guiding further clinical decision-making.
The anticipated impact of S-217622 includes providing a new therapeutic option that significantly improves outcomes for hospitalised COVID-19 patients. If successful, this treatment could reduce mortality rates, shorten hospital stays, and lessen the need for intensive medical interventions.
- 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
National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)
