The National Institutes of Health has presented a multi-site clinical trial comparing an investigational antiviral for the treatment of COVID-19. The healing agent, known as S-217622 or fumaric acid ensitrelvir, was discovered by Hokkaido University, Sapporo, Japan; and shionogi
The National Institute of Allergy and Infectious Diseases (NIAID), a component of NIH, is investing in the trial and is being run in collaboration with NIH’s National Center for the Advancement of Translational Sciences (NCATS). Developed under the auspices of NIH’s COVID-19 Acceleration Therapeutics Intervention and Vaccines (ACTIV), a public-private component, STRIVE can be adapted to compare multiple healing interventions during respiratory disease outbreaks, such as COVID-19 or influenza.
We hope that the effects of this test can be implemented to improve the popularity of care for others with COVID-19, which still causes many deaths every day in the United States, as well as our pandemic preparedness. The STRIVE protocol and clinical study infrastructure can be adapted to compare other agents for COVID-19, as well as remedies for other respiratory pathogens. “
Results from the ACTIV-3 trials, which evaluated remedies for hospitalized adults with COVID-19, indicated that ongoing viral replication would possibly play a role in disease progression to severe disease. The study team hypothesized that a significant number of hospitalized patients with COVID-19 19 may also benefit from antiviral treatment.
S-217622 suppresses SARS-CoV-2 replication by inhibiting the function of a key viral protein known as protease 3CL. The antiviral reduced COVID-19 symptoms in other people with mild to moderate COVID-19, regardless of risk points or vaccination status, based on effects shared through Shionogi from a phase 3 clinical trial conducted primarily in Japan. S-217622 was well tolerated and there were no serious adverse events or treatment-related deaths in the study. In November 2022, the drug obtained emergency regulatory approval in Japan, where it is known through the logo called Xocova. The ongoing ACTIV-2 SCORPIO-HR clinical trial, also funded through NIAID, is comparing antiviral in the outpatient population.
Jason Baker, M. D. , lead infectious disease officer at Hennepin Healthcare and associate professor of medicine at the University of Minnesota, Minneapolis, serves as chair of the trial. The trial co-chairs come with Marcelo Losso, M. D. , principal investigator at J. M. Hospital. Ramos Mejía in Buenos Aires, Argentina, and Director of the University Clinical Research Coordination in Latin America, Buenos Aires; and Shikha Vasudeva, M. D. , Assistant Professor of Medicine, Virginia Tech Carilion School of Medicine, Roanoke, and Infectious Disease Specialist, Department of Veterans Affairs Medical Center, Salem, Virginia.
Participants will be randomly assigned to obtain S-217622 or placebo. Neither researchers nor participants will know who is receiving the investigational drug. S-217622 is taken by mouth once for five days. The dose of the first day is 3 tablets of 125 milligrams (mg) in total 375 mg, followed by a tablet of 125 mg for the next 4 days. All participants will receive the popular COVID-19 care venue, which will likely differ by location, and will possibly come with other antiviral and immunomodulatory medications. , corticosteroids and/or anticoagulants.
Researchers will monitor and record participants’ physical prestige each and every day during the first week and then on predefined days over a 60-day period. Participants will also be asked to provide blood samples and nasal swabs for laboratory testing.
The research team will carry out analyses to detect any statistically significant differences, i. e. those that are unlikely due to the possibility, between the organization of the remedy and the organization of the placebo. The key measure they will focus on is whether other people receive S-217622. recover (defined as returning home and staying alive until day 60) faster than those of the placebo organization.
Participant protection will be closely monitored throughout the trial. An NIAID medical monitor will review any potential safety issues in real time, and an independent Data and Safety Monitoring Board (DSMB) will review safety and efficacy data.
The speed of enrollment and, ultimately, the time it takes to complete the trial will depend on the trajectory of COVID-19 cases in parts of the world. For more information about the trial, visit the Clinicaltrials. gov online page and search for identifier NCT05605093.
STRIVE is part of the public-private component of NIH ACTIV, which was introduced in April 2020 to expand a strategy of coordinated studies to prioritize and drive the progression of the most promising COVID-19 remedies and vaccines. STRIVE builds on ACTIV’s previous master protocols efforts that evaluated remedies for other people hospitalized with COVID-19. The STREVE Scientific Committee, chaired by Professor Jens Lundgren, M. D. , University of Copenhagen, is composed of experts in clinical trials from various medical specialties, in addition to infectious diseases, pulmonology, intensive care and emergency medicine. STRIVE is also overseen through a Steering Committee and a Community Advisory Board.
The Center for Statistics and Data Management at the University of Minnesota, led by James Neaton, Ph. D. , manages STRIVE in collaboration with 8 foreign focal points, combining the former ACTIV-1, ACTIV-3 and ACTIV-5. clinical trials sites. In total, STRIVE can register participants at more than two hundred sites on six inhabited continents.
National Institutes of Health
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