NCT05046561

Study to Reinforce Immunity (STRI) Phase 2 Clinical Trial

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 598 (estimated)
• Sponsor: Eyecheck, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	STRI Formula	STRI Formula is a combination of food based substances (botanicals, vitamins, minerals, and protein) with multiple, distinct, synergistic, direct and indirect antiviral effects against SARS-CoV-2
DRUG	Placebo	Placebo oral capsule

Timeline

• Start date: 2021-11-04
• Primary completion: 2022-12-01
• Completion: 2023-08-01
• First posted: 2021-09-16
• Last updated: 2022-09-09

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study