LOUISVILLE, Ky. — The University of Louisville is conducting clinical trials on a potential new treatment for COVID-19’s deadlier and more severe respiratory effects.
The treatment combats “cytokine storm,” an unchecked overreaction of the body’s immune system which can cause severe lung damage and make it difficult, if not impossible, for patients to breathe on their own. The treament is a new formulation of Aviptadil (RLF-100), produced by NeuroRx of Pennsylvania and Relief Therapeutics Holding, SA, of Geneva.
“We want to mitigate these storms,” said Rainer Lenhardt, M.D., the clinical trial lead and associate professor of anesthesiology and critical care in the UofL School of Medicine. “We’re doing anything we can to improve outcomes.”
While most coronavirus cases are mild, the lungs can swell and fill with fluid in severe and critical cases. This is a major cause of COVID-19 related deaths.
“These patients are terribly ill,” said Forest W. Arnold, D.O., M.Sc., an investigator on the clinical trial and an associate professor in the UofL Division of Infectious Diseases. “And because this virus is so novel, options for treatment are just now being developed. This gives us another option.”
UofL and other sites will treat at least 144 patients in this Phase 2b/3 trial. Participtants must be patients at UofL Hospital with COVID-19-induced severe respiratory failure which requires intubation and mechanical ventilation. These phases of the trial determine effectiveness while monitoring for adverse reactions.
The drug in this formulation acts as an anti-inflammatory agent, believed to protect alveolar type-2 cells in the lungs. These cells are essential to oxygen exchange and are thought to be a major target of the SARS-CoV-2 virus.
During the treatment’s Phase 1 trial which assessed safety and dosage, seven of eight patients with acute respiratory distress caused by sepsis were taken off breathing machines after receiving the drug. Six eventually left the hospital.
“Our No. 1 goal is to provide a potentially life-saving therapy to critically ill patients with COVID-19. The FDA has granted fast-track designation for RLF-100 underscoring the urgent need for new treatment options,” said Jonathan Javitt, M.D., M.P.H., CEO and chairman of NeuroRx. “We are excited to work with UofL and leverage its clinical research and infectious disease expertise to advance research in COVID-19.”