Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-28 @ 12:56 PM
Study NCT ID:
NCT05046561
Status:
UNKNOWN
Last Update Posted:
2022-09-09
First Post:
2021-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Reinforce Immunity (STRI) Phase 2 Clinical Trial
Sponsor:
Eyecheck, Inc.
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: