Release Date: September 14, 2020
BUFFALO, N.Y. — A team of internationally recognized scientists at the University at Buffalo with complementary expertise in the brain hormone melatonin, lung disease and infectious disease, are testing melatonin as a treatment for patients with mild and moderate COVID-19.
The Institutional Review Board at UB has granted approval to the researchers to use melatonin to treat COVID-19 patients under an Investigational New Drug Approval provisionally granted by the Food and the 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 will enroll 30 patients, of which 20 will be treated with melatonin and 10 will receive placebo.
The pilot study will inform the researchers 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, director of UB’s Clinical Research Office and deputy director of the university’s Clinical and Translational Science Institute (CTSI), is clinical co-principal investigator on the trial.
“Current proven treatments for COVID-19 are for patients severe enough to be hospitalized,” he said. “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 are eligible
The UB researchers plan to begin recruiting on or before Oct. 1. Outpatients who have tested positive for COVID-19 and whose disease is mild enough that they can be treated at home will be potentially eligible for this trial. Subjects will be screened for eligibility by phone first.
The trial is 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. 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 said.
“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,” said Jessica Reynolds, PhD, a co-investigator on the trial and associate professor of medicine in the Jacobs School.
Reynolds, whose research includes investigating the relationship between neuroimmune mechanisms of HIV/AIDS/TB infectivity, will assess the effectiveness of melatonin in mitigating the detrimental effects of cytokines on COVID-19 patients.
Assisting underserved populations
Dubocovich, who is also senior associate dean for diversity and inclusion in the Jacobs School, noted that the disproportionate burden of adverse outcomes related to COVID-19 that affect African Americans, Latinx populations and the elderly makes critical the identification of 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 said.
Information for individuals interested in participating will be posted at https://www.research.buffalo.edu/portal/clinicaltrial/ when the trial opens to enrollment.
In addition to Dubocovich, Sethi and Reynolds, Gregory Wilding, PhD, professor and chair of the Department of Biostatistics in the School of Public Health and Health Professions, is also leading this 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 are Alberto Monegro, MD, clinical assistant professor of medicine in the Division of Pulmonary and Critical Care Medicine of the Department of Medicine; Rajesh Kunadharaju, MD, a fellow in the Division of Pulmonary and Critical Care Medicine; and Daniel Zinkovsky, PharmD, a third-year student in the Jacobs School.