NeuroRx, Inc. has announced initiation of a Phase 2/3 clinical trial investigating the role of inhaled ZYESAMI (aviptadil).
The trial is being done for the treatment of patients with Severe COVID-19 in partnership with UCI Health of the University of California, Irvine.
UCI Health was also an important site in the recently-completed study of ZYESAMI for intravenous administration in patients with Critical COVID-19 Respiratory Failure.
The aim of the present 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.
Dr. Richard Lee, Interim Chief of UCI Health’s Division of Pulmonary Diseases and Critical Care Medicine and the Principal Investigator for the clinical trial, said, “We are excited to be the first clinical site for this crucial study, which aims to prevent patients from progressing to respiratory failure and being admitted into the ICU.”
He added: “We have seen the devastation of COVID-19 firsthand and recognize the importance of investigating all potential therapeutics, especially one like ZYESAMI”.
Dr. Lee further stated that its mechanism holds promise as a treatment for patients in the ICU with Critical COVID-19 and possibly also in the earlier stage of the disease, to reduce disease progression and respiratory failure.
What data says
ZYESAMI is a synthetic form of human Vasoactive Intestinal Peptide (VIP). As per emerging data, 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 leads to the alveolar collapse that is the hallmark of radiographic change in COVID-19. VIP blocks replication of the Coronavirus ups production of pulmonary surfactant, and blocks the virus-induced production of inflammatory cytokines in lab studies.
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(With inputs from The OnLook News Research Bureau)
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