The Study to Reinforce Immunity (STRI) Phase 2 Clinical Trial is a randomized, double-blind, placebo-controlled clinical trial protocol assessing the safety and efficacy of STRI Formula in non-hospitalized participants with COVID-19. STRI Formula is a combination of food-based substances designed specifically to combat SARS-CoV-2, the coronavirus that causes COVID-19.~The primary objective of the Study is to assess the efficacy of STRI Formula in reduction of time from treatment initiation to initial meaningful clinical improvement in COVID-19 symptoms. Additional secondary objectives are as follows:~To assess the safety of STRI Formula~To assess the efficacy of STRI Formula in reduction of time to COVID-19 sustained symptom improvement~To assess the efficacy of STRI Formula in reduction of time to COVID-19 initial symptom resolution~To assess the efficacy of STRI Formula in reduction of time to COVID-19 sustained symptom resolution~To assess the efficacy of STRI Formula in reduction in need for hospitalization~To assess the efficacy of STRI Formula in reduction in rates of fever~To assess the efficacy of STRI Formula in reduction in rates of hypoxia
Protocol STRI12 - Study to Reinforce Immunity (STRI) - A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of STRI Formula in Non-Hospitalized Participants with COVID-19 (the Study)