AMCOVID

Inspiration: The continued lack of a specific COVID treatment, determined us to explore alternate strategies, such as adjuvant treatments - treatments able to make a positive difference on treatment outcomes when added to other ongoing treatment approaches that may not be easily changed. We identified an adjuvant treatment capable to attenuate and mitigate viral-induced damage, like acute lung injury, pneumonia or acute respiratory distress syndrome. In addition to being reported by a network proximity analysis of drug targets as a potential anti-COVID repurposable drug, melatonin (MLT) offers unquestionable documented evidence.

What it does: A natural occurring sleep-inducing hormone with numerous pleiotropic properties, including free radical scavenging and anti-inflammatory actions, MLT distinguishes itself as an uniquely suited adjuvant treatment for COVID-19. MLT can attenuate the effects associated with viral inoculation in animals, including including the encephalo-myocarditis virus, the Semliki Forest virus, the West Nile virus, and the Venezuelan equine encephalitis virus. MLT prevented inflammation-induced lung injury in animals and has also an unsurpassed track of safety in humans. MLT was reported to prevent progression of radiation-induced oral mucositis, as well as decrease discomfort and pain in human subjects. According to a 21 clinical trials meta-analysis, the use of oral melatonin was associated with longer survival and decreased chemo-induced toxicity in cancer patients.

How we built it: MLT is approved for over-the-counter use throughout the globe. We currentky have discussions ongoing with one of the European MLT manufacturers to supply the drug for this study.

Challenges we ran into: We have no current funding to hire a contract research organization to intermediate the application for this clinical trial with the regulatory agency(ies). One of us can handle the process to apply with the FDA, but not with the local regulatory agency in Europe.

Accomplishments that we're proud of: We have a very solid study design and interested clinical sites to carry out the study at no cost.

What we learned: All we need to bring amazing people together is the right cause. If we find 1-2 motivated individuals to navigate the regulatory process, we are ready to submit the clinical study for approval.

What's next for AMCOVID: Regulatory approval for the clinical trial.