Covid19 Clinical Trial
Official title:
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
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)
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: 1. To assess the safety of STRI Formula 2. To assess the efficacy of STRI Formula in reduction of time to COVID-19 sustained symptom improvement 3. To assess the efficacy of STRI Formula in reduction of time to COVID-19 initial symptom resolution 4. To assess the efficacy of STRI Formula in reduction of time to COVID-19 sustained symptom resolution 5. To assess the efficacy of STRI Formula in reduction in need for hospitalization 6. To assess the efficacy of STRI Formula in reduction in rates of fever 7. To assess the efficacy of STRI Formula in reduction in rates of hypoxia ;
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