Recruiting
Phase 2

STRI Formula

Sponsor:

Eyecheck, Inc.

Code:

NCT05046561

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STRI Formula

Placebo

Study Details

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)

Conditions

Covid19

Study ID

NCT05046561

Start date

Nov 4, 2021

Status verified date

Sep, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 antigen testing) performed less than 7 days before screening, either via direct upload or confirmation from PCP.

1. electronic secure document upload;
2. allowing STRI Personnel to contact the PCP to confirm diagnosis; or
3. allowing STRI Personnel to contact the laboratory where the RT-PCR analysis was performed
3. Initial date of onset of COVID-19 signs/symptoms 7 days or less from date of STRI Screening and Randomization (i.e., Day 0).
4. During screening (Day 0):

1. participant-reported response of "Mild" or "Moderate" in response to the question "Overall, how severe were your infection symptoms today?" (FLU-PRO Plus Global Additional Daily Diary Items Question 1)
2. 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-PRO Plus Global Additional Daily Diary Items Question 2)
3. During prescreening, participant-reported response of "No" in response to the question "Have you returned to your usual health today?" (FLU-PRO Plus Global Additional Daily Diary Items Question 6)
4. 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/systemic domains)
5. Ability to self-measure and self-report body temperature, and peripheral oxygen saturation (with STRI provided thermometer and STRI provided pulse oximeter).
6. Provision of signed and dated electronic informed consent form (via 21 CFR Part 11 compliant platform).
7. Provision of participant's primary care physician (PCP) name and phone number.
8. Consent to allow STRI Personnel to contact PCP for any reason and discuss participant's medical history and/or obtain participant's medical records.
9. Stated willingness to comply with all study procedures and availability for the duration of the study, including intent to comply with lifestyle considerations throughout Study duration.
10. Ability to take oral medication and be willing to adhere to the STRI Intervention Product (STRI Formula or placebo as capsules) regimen.
11. Ability to use the internet daily and check email daily.
12. Ability and consent to send and receive SMS text messages via cellular phone.
13. Provision of information (name, email address, and cellular phone number) of an emergency contact (e.g., family member/friend/colleague) willing to communicate with STRI Personnel in case the participant deteriorates.
14. Willingness to discontinue any dietary supplement that contains any active ingredient in STRI Formula (ascorbic acid, cholecalciferol, zinc, copper, quercetin, hesperidin, caffeic acid, epigallocatechin gallate, bovine lactoferrin) for the duration of the Study.
15. For men and women with child-bearing potential (as defined below), willingness to use adequate contraception for at least 100 days after beginning the Study.

Exclusion Criteria:

1. Inability to comply with study or follow-up procedures, or provide regular updates to their 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 for any 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 STRI Formula (including ascorbic acid, vitamin D, zinc, copper, amla, caffeic acid, coffee, bovine lactoferrin, milk, quercetin, hesperidin, oranges, citrus fruits, and/or green tea)
5. Body Mass Index > 40 based on participant-reported weight and participant-reported height.
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 or gastrointestinal resection, inflammatory bowel disease, or chronic intestinal diseases, such as (but not limited to) eosinophilic enteritis or autoimmune enteritis).
11. Any history of mineral or vitamin overload or deficiency (including chronic iron overload states, copper overload states, or ascorbic acid, vitamin D, zinc, or copper deficiencies).
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 more indicating hazardous or harmful alcohol consumption, or alcohol dependence.
14. Pregnant or nursing/breastfeeding participants or participants intending to become pregnant 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 or increased risk to the participant or preclude the participant's full adherence with or completion of the study.

Study Design

Enrollment

598 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: STRI Formula

STRI Formula 3 capsules by mouth twice daily for 10 days

placebo comparator: Placebo

Placebo 3 capsules by mouth twice daily for 10 days

Interventions

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

Placebo

Placebo oral capsule

Primary outcome measure

  • Length of time from treatment initiation to initial meaningful clinical improvement as measured over 30 days. [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Luna Research

Recruiting

Coral Gables, Florida, United States, 33134

Contacts

Principal Investigator:

Carlos Bello

Solution Clinical Research

Recruiting

Doral, Florida, United States, 33178

Contacts

Principal Investigator:

Santos Reyes

South Florida Research

Recruiting

Medley, Florida, United States, 33166

Contacts

Yanis Castro

sfro2121@gmail.com

Principal Investigator:

Giralt Yanez

G+C Research Group

Recruiting

Miami, Florida, United States, 33126

Contacts

Principal Investigator:

Alina Alvarez

Dynamic Medical Research

Recruiting

Miami, Florida, United States, 33144

Contacts

Principal Investigator:

Reinaldo Hernandez-Loy

Vista Health

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

Antonio Blanco, E

Davila Medical Research

Recruiting

Miami, Florida, United States, 33184

Contacts

Principal Investigator:

Dieguez

A&A Research Group

Recruiting

Miami, Florida, United States, 33186

Contacts

Principal Investigator:

Nelson Sanchez

Affinity Clinical Research

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Cecilio Hernandez

Beat COVID

Recruiting

Oak Forest, Illinois, United States, 60452

Contacts

Principal Investigator:

Rama D Jager, MD

Dorisca Research Consulting

Recruiting

Houston, Texas, United States, 77090

Contacts

Principal Investigator:

Anand Balasubramanian

More Information

Sponsor

Eyecheck, Inc.

Last update posted

Sep 9, 2022

Last verified

Sep, 2022

Keywords

  • Covid-19 symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eyecheck, Inc. on 2022-09-09.