University of Buffalo Prepares Melatonin Trial Targeting Mild to Moderate COVID-19

University of Buffalo Prepares Melatonin Trial Targeting Mild to Moderate COVID-19 TrialsiteN

Could the natural sleep aid melatonin serve as a treatment for patients with mild and moderate COVID-19? Apparently, researchers at the University at Buffalo seek to find out, and the university Institutional Review Board granted approval to proceed. The U.S. Food and Drug Administration (FDA) already granted approval of the Investigational New Drug (IND) Application.

Any Evidence?

That melatonin would be considered for a clinical trial caught TrialSite’s attention. Hence a brief literature review.  A recent study out of Iran summarized existing evidence on melatonin therapy for viral infections with focus on underlying mechanisms of melatonin actions. In another study, a group based out of China and UT San Antonio proposes that melatonin should be included in adjuvant treatment for COVID-19 as it has proven mechanisms to target inflammasomes that trigger cytokine storms and acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2. 

The Study

Led by Sanjay Sethi, MD, director of UB’s Clinical Research Office and Deputy Director of the university’s Clinical and Translational Institute, UB’s randomized, double-blind, placebo-controlled pilot clinical trial (NCT04474483) testing melatonin actually is one of a very few worldwide to look at this common over-the-counter supplement. Enrolling 30 patients, 20 will be treated with melatonin and 10 will receive the placebo treatment. Seeking to determine safety, this pilot study will contribute to determine whether more studies should proceed.

Dr. Sethi offers, “current proven treatments for COVID-19 are for patients severe enough to be hospitalized.” He continued, “It would be a major advance to have a treatment that is effective in milder disease. The infrastructure and collaborations fostered by the CTSI over the past few years at UB are why the team that is putting this trial in motion was able to come together so quickly.”

The trial itself will actually be led by Margarita Dubocovich, PhD, SUNY Distinguished Professor in the Department of Pharmacology and Toxicology in the Jacobs School of Medicine and Biomedical Sciences at UB.

Lead Research/Investigator

Margarita Dubocovich, PhD, SUNY Distinguished Professor in the Department of Pharmacology and Toxicology in the Jacobs School of Medicine and Biomedical Sciences at UB.

Sanjay Sethi, MD, director of UB’s Clinical Research Office and deputy director of the university’s Clinical and Translational Institute