eClinical Technology and Industy News

NeuroRx Initiates Phase 2/3 Study of Inhaled ZYESAMI™ for Severe COVID-19 with UCI Health

Excerpt from the Press Release:

RADNOR, Pa. and IRVINE, Calif., Feb. 3, 2021 /PRNewswire/ — NeuroRx, Inc. today announced initiation of a Phase 2/3 clinical trial investigating the role of inhaled ZYESAMI™ (aviptadil) for the treatment of patients with Severe COVID-19 in partnership with UCI Health of the University of California, Irvine. UCI Health was also a key site in the recently-completed study of ZYESAMI™1 for intravenous administration in patients with Critical COVID-19 Respiratory Failure.  The objective of the current study is to determine whether aviptadil, administered at the earlier (Severe) stage of COVID-19 can reduce the likelihood of progression to Critical COVID-19 with respiratory failure: the predominant cause of death in COVID.

ZYESAMI™ is a synthetic form of human Vasoactive Intestinal Peptide (VIP). Emerging data indicate that the drug protects the alveolar type II cells upon which the lung depends for production of surfactant and which are the primary target of the SARS-CoV-2 Coronavirus. Loss of surfactant causes the alveolar collapse that is the hallmark of radiographic change in COVID-19. VIP blocks replication of the Coronavirus, increases production of pulmonary surfactant, and blocks the virus-induced production of inflammatory cytokines in laboratory experiments.

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