Vanderbilt University Medical Center is evaluating razuprotafib, a drug being investigated for the treatment of glaucoma, in a new randomized, investigational trial for the prevention and treatment of acute respiratory distress syndrome (ARDS) in adult patients with moderate to severe COVID-19.
“We urgently need to find effective treatments for COVID-19, especially for patients who develop severe lung injury from the virus,” said co-principal investigator Wesley Self, MD, an emergency medicine physician at Vanderbilt University Medical Center.
“Razuprotafib is a medication that is very different from many of the medications that are being tested as COVID-19 treatments. It works on the blood vessels in the lung to prevent fluid from building up, which is one of the main complications of severe COVID-19 infection. We will be testing if this medication prevents patients with COVID-19 from getting the most severe forms of lung injury and dying,” he said.
ARDS is a life-threatening complication where fluid leaks into the lungs, often triggered by injury to the lungs. In the case of COVID-19 infections, it is triggered by inflammation reacting to the SARS-CoV-2 virus responsible for the infections. The fluid build-up makes breathing difficult and adequate oxygen does not get to the body, resulting in patients needing supplemental oxygen or mechanical ventilation for weeks at a time in some cases.
“We think the drug will prevent the development of edema (swelling) in the lungs in response to COVID-19. We are doing this trial to test that hypothesis — that this drug prevents patients with COVID-19 from getting worse with lung injury,” said Self, who is vice chair of Research in the Department of Emergency Medicine.
This study is funded through an agreement with Aerpio Pharmaceuticals and Medical Technology Enterprise Consortium (MTEC), which is part of the Military Infectious Disease Research Program’s (MIDRP) initiative to find treatments for COVID-19.
MTEC, a 501(c)3 organization primarily funded by the U.S. Army Medical Research and Development Command, will provide up to $5.1 million in funding toward the clinical trial. Aerpio will support the trial with “in kind” spending in the amount of $3.1 million.
The trial’s other co-principal investigator is Samir Parikh, MD, professor of Medicine, director, Center for Vascular Biology Research, and associate vice chair for Research, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School.
