Study to Reinforce Immunity (STRI) Phase 2 Clinical Trial

Last updated: September 8, 2022
Sponsor: Eyecheck, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05046561
STRI12
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults residing in the United States aged 18 years or older.
  2. Provision of documentation of positive SARS-CoV-2 testing (via RT-PCR, rapid antigentesting) performed less than 7 days before screening, either via direct upload orconfirmation from PCP.
  3. electronic secure document upload;
  4. allowing STRI Personnel to contact the PCP to confirm diagnosis; or
  5. allowing STRI Personnel to contact the laboratory where the RT-PCR analysis wasperformed
  6. Initial date of onset of COVID-19 signs/symptoms 7 days or less from date of STRIScreening and Randomization (i.e., Day 0).
  7. During screening (Day 0):
  8. participant-reported response of "Mild" or "Moderate" in response to the question "Overall, how severe were your infection symptoms today?" (FLU-PRO Plus GlobalAdditional Daily Diary Items Question 1)
  9. During prescreening, participant self-reported response of "A little worse" or "Somewhat worse" or "Much worse" or "About the same" in response to the question "Overall, how were your infection symptoms today compared to yesterday?" (FLU-PROPlus Global Additional Daily Diary Items Question 2)
  10. During prescreening, participant-reported response of "No" in response to thequestion "Have you returned to your usual health today?" (FLU-PRO Plus GlobalAdditional Daily Diary Items Question 6)
  11. At least TWO participant self-reported responses of "Somewhat," "Quite A Bit," or "Very Much" in any FLU-PRO Plus domain other than smell and taste (i.e., nose,throat, eyes, chest/respiratory, head, gastrointestinal, or body/systemicdomains)
  12. Ability to self-measure and self-report body temperature, and peripheral oxygensaturation (with STRI provided thermometer and STRI provided pulse oximeter).
  13. Provision of signed and dated electronic informed consent form (via 21 CFR Part 11compliant platform).
  14. Provision of participant's primary care physician (PCP) name and phone number.
  15. Consent to allow STRI Personnel to contact PCP for any reason and discussparticipant's medical history and/or obtain participant's medical records.
  16. Stated willingness to comply with all study procedures and availability for theduration of the study, including intent to comply with lifestyle considerationsthroughout Study duration.
  17. Ability to take oral medication and be willing to adhere to the STRI InterventionProduct (STRI Formula or placebo as capsules) regimen.
  18. Ability to use the internet daily and check email daily.
  19. Ability and consent to send and receive SMS text messages via cellular phone.
  20. Provision of information (name, email address, and cellular phone number) of anemergency contact (e.g., family member/friend/colleague) willing to communicate withSTRI Personnel in case the participant deteriorates.
  21. Willingness to discontinue any dietary supplement that contains any active ingredientin STRI Formula (ascorbic acid, cholecalciferol, zinc, copper, quercetin, hesperidin,caffeic acid, epigallocatechin gallate, bovine lactoferrin) for the duration of theStudy.
  22. For men and women with child-bearing potential (as defined below), willingness to useadequate contraception for at least 100 days after beginning the Study.

Exclusion

Exclusion Criteria:

  1. Inability to comply with study or follow-up procedures, or provide regular updates totheir health status when contacted by the STRI Personnel via email, SMS, or phone.
  2. Any prior or current hospitalization for COVID-19 or any need for hospitalization forany reason.
  3. Any prior or current treatment with any agent for COVID-19.
  4. Any known allergies or known toxicities to any of the specific ingredients in STRIFormula (including ascorbic acid, vitamin D, zinc, copper, amla, caffeic acid, coffee,bovine lactoferrin, milk, quercetin, hesperidin, oranges, citrus fruits, and/or greentea)
  5. Body Mass Index > 40 based on participant-reported weight and participant-reportedheight.
  6. Participant-reported weight of less than 35kg.
  7. Any history of radiation or chemotherapy for cancer within the last 3 months.
  8. Any history of cardiac arrythmias, hemochromatosis, renal (including any known GFR < 60mL/min) or hepatic disease (including chronic liver disease).
  9. Any history of chronic pulmonary disorders
  10. Any history of any gastrointestinal surgery or disease (including bariatric surgery orgastrointestinal resection, inflammatory bowel disease, or chronic intestinaldiseases, such as (but not limited to) eosinophilic enteritis or autoimmuneenteritis).
  11. Any history of mineral or vitamin overload or deficiency (including chronic ironoverload states, copper overload states, or ascorbic acid, vitamin D, zinc, or copperdeficiencies).
  12. Any history of any adverse event to green tea extract or any herbal products.
  13. Prescreening Alcohol Use Disorders Identification Test (AUDIT) score of 8 or moreindicating hazardous or harmful alcohol consumption, or alcohol dependence.
  14. Pregnant or nursing/breastfeeding participants or participants intending to becomepregnant within the next 24 months.
  15. Men or premenopausal women not using adequate contraception.
  16. Any other factors as judged by the principal investigator that would cause harm orincreased risk to the participant or preclude the participant's full adherence with orcompletion of the study.

Study Design

Total Participants: 598
Study Start date:
November 04, 2021
Estimated Completion Date:
August 31, 2023

Study 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

Connect with a study center

  • Xera Med Research

    Boca Raton, Florida 33487
    United States

    Site Not Available

  • Luna Research

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Prohealth Research Center

    Doral, Florida 33166
    United States

    Site Not Available

  • Solution Clinical Research

    Doral, Florida 33178
    United States

    Active - Recruiting

  • South Florida Research

    Medley, Florida 33166
    United States

    Active - Recruiting

  • A&A Research Group

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Davila Medical Research

    Miami, Florida 33184
    United States

    Active - Recruiting

  • Dynamic Medical Research

    Miami, Florida 33144
    United States

    Active - Recruiting

  • G+C Research Group

    Miami, Florida 33126
    United States

    Active - Recruiting

  • The Miami Research Group

    Miami, Florida 33186
    United States

    Site Not Available

  • Vista Health

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Affinity Clinical Research

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Beat COVID

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Dorisca Research Consulting

    Houston, Texas 77090
    United States

    Active - Recruiting

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