(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.