Data Safety Monitoring Board update on U.S. National Institutes of Health (NIH) study of Zyesami in COVID-19 Respiratory Failure.- NRx Pharma
NRx Pharmaceuticals, Inc. announced results of a review conducted by the Data Safety and Monitoring Board (DSMB) on May 25, 2022. The DSMB reviewed data of approximately 460 patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial, most of which had reached the 90-day endpoint.
The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The DSMB recommended stopping further randomization to aviptadil (Zyesami) due to aviptadil not meeting the futility guidelines outlined by the pre-approved analytical plan. The primary endpoint (90 day 6-category ordinal score) was not supportive (OR 1.10; 0.79 – 1.54; p=0.56), and 90-day mortality secondary endpoint was also not supportive with 37% mortality in the aviptadil group vs 36% in the placebo group; HR 1.04 (0.77-1.41); p=0.79.There were no safety concerns, the known side effects of aviptadil (principally diarrhea and hypotension) were managed well with the protocols in place.
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