A new Phase 3 trial to test the safety and efficacy of therapeutics for COVID-19 has begun enrolling patients hospitalized with life-threatening cases of COVID-19, including those with acute respiratory failure.

The trial is supported by two components of the National Institutes of Health, the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung and Blood Institute (NHLBI), and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership.

The randomized, blinded, placebo-controlled clinical trial is called ACTIV-3 Critical Care.

It will begin by testing Zyesami, a formulation of aviptadil acetate, produced by NeuroRx, Wilmington, Delaware, and the antiviral remdesivir (Veklury), developed by Gilead, Foster City, California. Aviptadil is a synthetic version of Vasoactive Intestinal Peptide or VIP, which is made naturally in the human body and appears to have lung-protective antiviral and anti-inflammatory effects.

During the trial, an independent Data and Safety Monitoring Board (DSMB) will review the data on an ongoing basis.

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