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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
598
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
Placebo oral capsule
Luna Research
Coral Gables, Florida, United States
RECRUITINGProhealth Research Center
Doral, Florida, United States
NOT_YET_RECRUITINGLength of time from treatment initiation to initial meaningful clinical improvement as measured over 30 days.
Time frame: 30 days
Proportion of participants with any recorded serious adverse events
Time frame: 30 days
Proportion of participants with any new comprehensive metabolic panel abnormalities (including electrolyte levels, glucose levels, renal and liver function testing) related to STRI Intervention Product between baseline and 30 days.
Time frame: 30 days
Proportion of participants with any new complete blood count abnormalities (including white blood cell, red blood cell, hemoglobin, and platelets) related to STRI Intervention Product between baseline and 30 days.
Time frame: 30 days
Proportion of participants that develop fever (measured as body temperature of more than 100.4 degrees F using a participant self-recorded thermometer).
Time frame: 30 days
Proportion of participants that develop hypoxia (measured as peripheral oxygen saturation of less than 93% using a participant self-recorded pulse oximeter).
Time frame: 30 days
Length of time from treatment initiation to sustained meaningful clinical improvement.
Time frame: 30 days
Length of time from treatment initiation to initial clinical recovery.
Time frame: 30 days
Length of time from treatment initiation to sustained clinical recovery.
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Solution Clinical Research
Doral, Florida, United States
RECRUITINGSouth Florida Research
Medley, Florida, United States
RECRUITINGG+C Research Group
Miami, Florida, United States
RECRUITINGDynamic Medical Research
Miami, Florida, United States
RECRUITINGVista Health
Miami, Florida, United States
RECRUITINGDavila Medical Research
Miami, Florida, United States
RECRUITINGA&A Research Group
Miami, Florida, United States
RECRUITINGThe Miami Research Group
Miami, Florida, United States
NOT_YET_RECRUITING...and 3 more locations
Time frame: 30 days
Proportion of participants requiring hospitalization.
Time frame: 30 days
Proportion of participants with COVID-19 signs/symptoms.
Time frame: 30 days
Proportion of participants with COVID-19 signs/symptoms
Time frame: 60 days
Proportion of participants who have expired.
Time frame: 30 days
Proportion of participants who have expired.
Time frame: 60 days