Posted November 25, 2020
A team of internationally renowned scientists from the Jacobs School of Medicine and Biomedical Sciences are testing melatonin as a treatment for patients with mild and moderate COVID-19.
30 patients will be enrolled in a pilot study
The UB Institutional Review Board has cleared researchers – who have complementary expertise in the brain hormone melatonin, lung disease, and infectious disease – to use melatonin to treat COVID-19 patients in the context of ” an approval of a new investigational drug granted provisionally by the Food and Drug Administration.
UB’s randomized, double-blind, placebo-controlled melatonin clinical trial is one of the few to be conducted worldwide and the only one in New York State. This pilot trial is currently recruiting 30 patients, of whom 20 are receiving melatonin and 10 are receiving a placebo.
The pilot study will educate researchers on whether the dose of melatonin that will be used in the study is safe for patients with COVID-19. The results will also serve as a basis for more definitive studies.
Major breakthrough in the treatment of out-of-hospital patients
Sanjay Sethi, MD, professor of medicine and head of the Division of Pulmonary Medicine, Critical Care and Sleep, is the clinical principal co-investigator of the trial.
“The currently proven treatments for COVID-19 are for patients severe enough to be hospitalized,” says Sethi, director of UB Clinical Research Office and deputy director of UB Institute of Clinical and Translational Sciences. “It would be a major breakthrough to have effective treatment for milder diseases. The infrastructure and collaborations CTSI has fostered over the past few years at UB is why the team implementing this trial was able to come together so quickly.
Cuts inflammation, improves immunity
Outpatients who have tested positive for COVID-19 and whose illness is mild enough to be treated at home are potentially eligible for this trial. The eligibility of subjects is first reviewed by telephone.
The trial is led by Margarita L. Dubocovich, PhD, SUNY Emeritus Professor of Pharmacology and Toxicology and Senior Associate Dean for Diversity and Inclusion. Over the past decades, she has made a major contribution to the scientific understanding of the impact of melatonin on circadian rhythms, sleep disturbances, substance abuse and depression.
“Given what research has shown on the anti-inflammatory, anti-oxidant and immune properties of melatonin in other diseases, it is essential that we investigate whether it may be useful in treating mild cases or moderates of COVID-19, ”Dubocovich says.
“In several animal models of acute lung injury, melatonin decreased pro-inflammatory molecules, such as cytokines, whose levels 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 co-investigator on the trial.
Reynolds, whose research includes studying the relationship between the neuro-immune mechanisms of HIV / AIDS / tuberculosis infectivity, will assess the effectiveness of melatonin in mitigating the damaging effects of cytokines in COVID-19 patients.
Help underserved populations
Dubocovich notes that the disproportionate burden of COVID-19-related adverse reactions affecting African Americans, Latinx populations and the elderly makes it essential to find inexpensive and widely available treatment for the novel coronavirus.
“The value of an inexpensive, widely available, and effective treatment that could mitigate the damaging effects of COVID-19 – especially in underserved populations – cannot be overstated,” she says.
Besides Dubocovich, Sethi and Reynolds, Gregory Wilding, PhD, professor and chair of biostatistics at 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 accelerate the development of new treatments from the laboratory to the patients, in large part by attracting more patients to participate and benefit from clinical trials.
Additional investigators from the Jacobs School are: