Study to Reinforce Immunity (STRI) Phase 2 Clinical Trial
1 other identifier
interventional
598
1 country
13
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Nov 2021
Longer than P75 for phase_2 covid19
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedStudy Start
First participant enrolled
November 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedSeptember 9, 2022
September 1, 2022
1.1 years
September 8, 2021
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of time from treatment initiation to initial meaningful clinical improvement as measured over 30 days.
30 days
Secondary Outcomes (13)
Proportion of participants with any recorded serious adverse events
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.
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.
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).
30 days
Proportion of participants that develop hypoxia (measured as peripheral oxygen saturation of less than 93% using a participant self-recorded pulse oximeter).
30 days
- +8 more secondary outcomes
Other Outcomes (1)
Proportion of participants with PCR positivity for SARS-CoV-2 at 5, 10, 15, and 30 in saliva samples (first-stage only) compared to Day 1 (before treatment initiation)
30 days
Study Arms (2)
STRI Formula
ACTIVE COMPARATORSTRI Formula 3 capsules by mouth twice daily for 10 days
Placebo
PLACEBO COMPARATORPlacebo 3 capsules by mouth twice daily for 10 days
Interventions
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
Eligibility Criteria
You may qualify if:
- Adults residing in the United States aged 18 years or older.
- 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.
- electronic secure document upload;
- allowing STRI Personnel to contact the PCP to confirm diagnosis; or
- allowing STRI Personnel to contact the laboratory where the RT-PCR analysis was performed
- Initial date of onset of COVID-19 signs/symptoms 7 days or less from date of STRI Screening and Randomization (i.e., Day 0).
- During screening (Day 0):
- 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)
- 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)
- 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)
- 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)
- Ability to self-measure and self-report body temperature, and peripheral oxygen saturation (with STRI provided thermometer and STRI provided pulse oximeter).
- Provision of signed and dated electronic informed consent form (via 21 CFR Part 11 compliant platform).
- Provision of participant's primary care physician (PCP) name and phone number.
- Consent to allow STRI Personnel to contact PCP for any reason and discuss participant's medical history and/or obtain participant's medical records.
- +7 more criteria
You may not qualify if:
- 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.
- Any prior or current hospitalization for COVID-19 or any need for hospitalization for any reason.
- Any prior or current treatment with any agent for COVID-19.
- 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)
- Body Mass Index \> 40 based on participant-reported weight and participant-reported height.
- Participant-reported weight of less than 35kg.
- Any history of radiation or chemotherapy for cancer within the last 3 months.
- Any history of cardiac arrythmias, hemochromatosis, renal (including any known GFR \< 60mL/min) or hepatic disease (including chronic liver disease).
- Any history of chronic pulmonary disorders
- 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).
- 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).
- Any history of any adverse event to green tea extract or any herbal products.
- Prescreening Alcohol Use Disorders Identification Test (AUDIT) score of 8 or more indicating hazardous or harmful alcohol consumption, or alcohol dependence.
- Pregnant or nursing/breastfeeding participants or participants intending to become pregnant within the next 24 months.
- Men or premenopausal women not using adequate contraception.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyecheck, Inc.lead
Study Sites (13)
Luna Research
Coral Gables, Florida, 33134, United States
Prohealth Research Center
Doral, Florida, 33166, United States
Solution Clinical Research
Doral, Florida, 33178, United States
South Florida Research
Medley, Florida, 33166, United States
G+C Research Group
Miami, Florida, 33126, United States
Dynamic Medical Research
Miami, Florida, 33144, United States
Vista Health
Miami, Florida, 33176, United States
Davila Medical Research
Miami, Florida, 33184, United States
A&A Research Group
Miami, Florida, 33186, United States
The Miami Research Group
Miami, Florida, 33186, United States
Affinity Clinical Research
Tampa, Florida, 33612, United States
Beat COVID
Oak Forest, Illinois, 60452, United States
Dorisca Research Consulting
Houston, Texas, 77090, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rama D Jager, MD
Eyecheck, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2021
First Posted
September 16, 2021
Study Start
November 4, 2021
Primary Completion
December 1, 2022
Study Completion
August 1, 2023
Last Updated
September 9, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Data from this study may be requested from other researchers 3 years after the completion of the primary endpoint by contacting the PI.
- Access Criteria
- Users of the STRI Dataset will be required to agree to terms that prohibit unlawful uses and intentional violations of privacy and require attribution.
After the study is completed, the de-identified, archived data may be transmitted to and stored for use by other researchers including those outside of the study. Permission to transmit de-identified data to other researchers has been included in the informed consent. Data from this study may be requested from other researchers 3 years after the completion of the primary endpoint by contacting the PI.