The Efficacy of Nitric Oxide-Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patients of African American and Hispanic Origin.

"Declaration of Competing Interest Thank you for consideration of our paper for publication in American Journal of Medicine. This letter should confirm that I serve as Founder and CEO of Nitric Oxide Innovations, the company that develops and markets nitric oxide-based therapeutics, including Noviricid. Please let me know if you need any additional information."

"Funding This trial was sponsored by Nitric Oxide Innovations, LCC with an unrestricted grant."

"This study was a randomized, double blinded, prospective, placebo controlled clinical trial conducted under an Investigational New Drug Application (IND# 150758). The Study was approved by Solution IRB (Yarnell, AZ) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT04601077). The study was performed in the United States and involved 30 screening centers that initially screened the patients and then the patients were followed by a Central Coordinating Center which contacted the patients 2 to 3 times a week for 30 days. The objective of the study was to determine the safety and efficacy of NOviricid™, an orally disintegrating sodium nitrite lozenge (30 mg) that generates NO in patients (not hospitalized) with a diagnosis of COVID-19. The study drug and placebo were provided by the sponsor, Nitric Oxide Innovations, LLC."