- STRIVE (ClinicalTrials.gov Identifier: NCT05605093): Today, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced the first patient was enrolled in a global multi-site clinical trial evaluating ensitrelvir in patients who are hospitalized for the management of COVID-19 as part of the new Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) platform protocol.3 STRIVE was developed under the auspices of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. Ensitrelvir is the first drug to be evaluated in the STRIVE program, a new agile research approach set up to rapidly assess interventions during epidemics adversely affecting public health. It will evaluate the safety and efficacy of a five-day course of ensitrelvir, given in addition to standard of care, for hospitalized patients with COVID-19, when compared to placebo. The study will recruit 1,500 patients across sites worldwide and is expected to be complete in early 2024.
- SCORPIO-HR (ClinicalTrials.gov Identifier: NCT05305547): The global Phase 3 trial (SCORPIO-HR study) in non-hospitalized symptomatic SARS-CoV-2 infected patients is ongoing and includes outpatient adults who have tested positive for COVID-19, including patients regardless of risk factors or vaccination status. This NIH-supported study, also part of ACTIV, is being conducted by the AIDS Clinical Trials Group (ACTG), the largest global HIV research network which expanded its focus to include evaluating outpatient treatments for COVID-19. This study will recruit approximately 1,500 patients in Europe, South America, North America, Africa, and Asia and is expected to be complete in the second half of 2023. For information on eligibility for this study, please visit www.treatcovidearlystudy.com
- SCORPIO-PEP: Shionogi plans to initiate a post-exposure prevention global Phase 3 trial, SCORPIO-PEP. This trial will evaluate the safety and efficacy of ensitrelvir in the prevention of symptomatic SARS-CoV-2 infection from household contacts of people who tested positive for COVID-19, when compared to placebo. It will recruit more than 1,800 participants in Europe, South America, North America, Africa, and Asia, starting in early 2023.
- Pediatric Trial: Shionogi plans to initiate a Phase 3 pediatric study evaluating the safety and effectiveness of ensitrelvir for children ages 6-12 in Japan, starting in early 2023.
For Further Information, Contact:
1. Committee regarding the coronavirus disease pandemic. World Health Organization Website. Accessed January 31, 2023. Available at: https://www.who.int/news/item/30-01-2023-statement-on-the-fourteenth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic.
2. Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor. ClinicalTrials.gov Website. Accessed February 15, 2023. Available at https://clinicaltrials.gov/ct2/show/NCT05605093?term=S-217622&draw=2&rank=4.
3. NIH trial to evaluate Shionogi antiviral in adults hospitalized with COVID-19 press release page. National Institutes of Health Website. Accessed February 15, 2023. Available at https://www.nih.gov/news-events/news-releases/nih-trial-evaluate-shionogi-antiviral-adults-hospitalized-covid-19.