Funded Projects

Overproduction of cytokines and chemokines is believed to contribute to the development in COVID-19 disease. Melatonin, a pineal hormone, has been shown to have anti-inflammation, anti-oxidation and immune enhancing features. Melatonin supplementation has been shown to decrease the number of inflammatory cells, reduce the levels of the cytokines IL-4, IL-5, IL-13 and TNF-∝ and reduce nitric oxide and hydroxyl radical concentrations. We propose to conduct a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in 30 outpatient adult patients afflicted with COVID-19, with a 2:1 randomization to melatonin:placebo. Melatonin will be dosed at 10mg PO tid for 14 days. The primary objective is to evaluate the safety of the intervention through 42 days as assessed by cumulative incidence of serious adverse events, cumulative incidence of Grade 3 and 4 adverse events, discontinuation or temporary suspension of the investigational medication (for any reason). Secondary objectives include evaluating the clinical efficacy of Melatonin as compared to placebo as assessed by hospitalization, COVID-19 related symptoms and mortality. The exploratory objective will evaluate the effect of Melatonin on virologic parameters and cytokine production compared to placebo. Melatonin is readily available, is inexpensive and amenable to treat large populations if proven to attenuate the effects of the COVID-19. A Pre-Investigational New Drug Application (PIND-150700) was filed with the FDA; based on their positive response we are now preparing the full IND application. This pilot project will generate feasibility data for submission of extramural federal (e.g., R01, R21, P01, BARDA and/or NCATS grant mechanisms) and foundation research grant award applications. We have received $7,500 in support of this project from SUNY SEED grants for COVID-19. With the Blue Sky support we will be able to commence the study.