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 ACTIV-3 Critical Care trial will begin by testing Zyesami, a formulation of aviptadil acetate, produced by NeuroRx, and the antiviral remdesivir (Veklury), developed by Gilead.
Aviptadil is a synthetic version of Vasoactive Intestinal Peptide (VIP), which is made naturally in the human body and appears to have lung-protective antiviral and anti-inflammatory effects.
Administered intravenously, it may provide additional protection for lung cells commonly targeted by SARS-CoV-2, the virus that causes COVID-19. It is licensed in the United States for treating hospitalized patients with COVID-19. However, its benefit in patients with more severe COVID-19 is unclear.
The trial will test Zyesami and remdesivir (alone and in combination), for their safety and efficacy in hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS), a life-threatening condition in which the lungs are severely inflamed and may be unable to maintain sufficient oxygen in the blood.
“Finding more effective therapeutics for critically ill COVID-19 patients remains an essential need in the ongoing response to the pandemic,” said NIAID Director Anthony S. Fauci.
“We need more treatment options to increase the chances of recovery for people who are extremely sick so they can leave the hospital more quickly, continue their recovery at home, and return to life as usual.”