Patients With Mild COVID-19 Being Treated With Melatonin

The Institutional Review Board at UB has granted approval to the researchers — who have complementary expertise in the brain hormone melatonin, lung disease and infectious diseases — to use melatonin to treat COVID-19 patients under an Investigational New Drug approval provisionally granted by the Food and Drug Administration.

UB’s randomized, double-blind, placebo-controlled clinical trial on melatonin is one of the few being conducted around the world, and the only one in New York State. This pilot trial is currently enrolling 30 patients, of which 20 are being treated with melatonin and 10 are receiving placebo. 

The pilot study will inform the researchers on whether the dose of melatonin that will be used in the study is safe for COVID-19 patients. The findings will also provide the basis for more definitive studies.

Sanjay Sethi, MD, professor of medicine and chief of the Division of Pulmonary, Critical Care and Sleep Medicine, is clinical co-principal investigator on the trial. 

“Current proven treatments for COVID-19 are for patients severe enough to be hospitalized,” says Sethi, who is director of UB’s Clinical Research Office and deputy director of UB’s Clinical and Translational Science Institute. “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 rapidly.”

Outpatients who have tested positive for COVID-19 and whose disease is mild enough that they can be treated at home are potentially eligible for this trial. Subjects are screened for eligibility by phone first. 

The trial is being led by Margarita L. Dubocovich, PhD, SUNY Distinguished Professor of pharmacology and toxicology and senior associate dean for diversity and inclusion. Over the past several decades, she has made major contributions to the scientific understanding of how melatonin impacts circadian rhythms, sleep disorders, drug addiction and depression.

“Given what research has shown about melatonin’s anti-inflammatory, anti-oxidation and immune-enhancing properties in other diseases, it is critical that we investigate whether it can be of use in treating mild or moderate cases of COVID-19,” Dubocovich says.

“In multiple animal models of acute lung injury, melatonin has decreased pro-inflammatory molecules, such as cytokines, levels of which are known to contribute to the severity of COVID-19,” says Jessica L. Reynolds, PhD, associate professor of medicine in the Division of Allergy, Immunology and Rheumatology and a co-investigator on the trial.

Reynolds, whose research includes investigating the relationship between neuroimmune mechanisms of HIV/AIDS/tuberculosis infectivity, will assess the effectiveness of melatonin in mitigating the detrimental effects of cytokines on COVID-19 patients.

Dubocovich notes that the disproportionate burden of adverse outcomes related to COVID-19 that affect African Americans, Latinx populations and the elderly makes it critical to find an inexpensive, widely available treatment for the novel coronavirus. 

“The value of a low-cost, widely available and effective treatment that could attenuate the detrimental effects of COVID-19 — especially in underserved populations — cannot be overstated,” she says.

In addition to Dubocovich, Sethi and Reynolds, Gregory Wilding, PhD, professor and chair of biostatistics in the School of Public Health and Health Professions, is also leading the clinical trial. All are key members or leaders of UB’s CTSI, which is funded by the National Center for Advancing Translational Sciences of the National Institutes of Health. The goal of the CTSI is to help speed development of new treatments from the lab bench to patients, in large part by getting more patients to participate in and benefit from clinical trials. 

Additional investigators from the Jacobs School are:

• Alberto F. Monegro, MD, assistant professor of medicine in the Division of Pulmonary, Critical Care and Sleep Medicine
• Rajesh Kunadharaju, MD, a trainee in the pulmonary disease and critical care fellowship program
• Daniel Zinkovsky, a third-year medical student