Covid19Phase 2NCT05046561
Study to Reinforce Immunity (STRI) Phase 2 Clinical Trial
A Phase 2 study testing STRI Formula in people with Covid19, run by Eyecheck, Inc. at 13 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- STRI Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 598 participants
- Where
- 13 sitesUnited States
- Study dates
- 4 Nov 2021to Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
- 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.
- Ability to take oral medication and be willing to adhere to the STRI Intervention Product (STRI Formula or placebo as capsules) regimen.
- Ability to use the internet daily and check email daily.
- Ability and consent to send and receive SMS text messages via cellular phone.
- 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.
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Luna Research
Coral Gables, Florida, 33134
Simon Gomez, 305-363-7761, sglunaresearch@gmail.com
Carlos Bello
- Not yet recruiting
Prohealth Research Center
Doral, Florida, 33166
Andrea Padro, regulatory@prohealthresearch.com
David Jativa
- Recruiting
Solution Clinical Research
Doral, Florida, 33178
Maria Isesalaya, misesalaya@solutionclinicalresearch.com
Santos Reyes
- Recruiting
Dorisca Research Consulting
Houston, Texas, 77090
Ashley Carter, 407-694-2116, acarter@researchdrc.com
Anand Balasubramanian
- Recruiting
South Florida Research
Medley, Florida, 33166
Yanis Castro, sfro2121@gmail.com
Giralt Yanez
- Recruiting
G+C Research Group
Miami, Florida, 33126
Jacqueline Garcia, 305-283-6254, Jg.gcgroup@gmail.com
Alina Alvarez
- Recruiting
Dynamic Medical Research
Miami, Florida, 33144
Annialin Mederos, 888-367-2155, mederos.dmr@gmail.com
Reinaldo Hernandez-Loy
- Recruiting
Vista Health
Miami, Florida, 33176
Janell Miron, 786-636-6695, jmiron@vista-health.com
Antonio Blanco, E
- Recruiting
Davila Medical Research
Miami, Florida, 33184
Norma Prado, 786-631-4972, davilaresearch@gmail.com
Dieguez
- Recruiting
A&A Research Group
Miami, Florida, 33186
Belkis Barbon, 786-539-8927, misesalaya@solutionclinicalresearch.com
Nelson Sanchez
- Not yet recruiting
The Miami Research Group
Miami, Florida, 33186
Meunix Otero, motero@miamiresearchgroup.com
Manuel Franco
- Recruiting
Beat COVID
Oak Forest, Illinois, 60452
Taron Asatryan, BSLAS, 708-620-4608, tasatryan@beatcovidtrial.com
Melissa Ruelas, BS, 7086204608, mruelas@beatcovidtrial.com
- Recruiting
Affinity Clinical Research
Tampa, Florida, 33612
Carlos Mujica, 813-930-8424, affinityclinicalr@gmail.com
Cecilio Hernandez
About this study
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
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)
Read the 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:
- To assess the safety of STRI Formula
- To assess the efficacy of STRI Formula in reduction of time to COVID-19 sustained symptom improvement
- To assess the efficacy of STRI Formula in reduction of time to COVID-19 initial symptom resolution
- To assess the efficacy of STRI Formula in reduction of time to COVID-19 sustained symptom resolution
- To assess the efficacy of STRI Formula in reduction in need for hospitalization
- To assess the efficacy of STRI Formula in reduction in rates of fever
- To assess the efficacy of STRI Formula in reduction in rates of hypoxia
- Conditions
- Covid19
- Being tested
- STRI Formula, Placebo
- Keywords
- Covid-19 symptoms
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRI FormulaDrug
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
PlaceboDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| STRI Formula | Active comparator | STRI Formula 3 capsules by mouth twice daily for 10 days Receives: Drug: STRI Formula |
| Placebo | Placebo comparator | Placebo 3 capsules by mouth twice daily for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time from treatment initiation to initial meaningful clinical improvement as measured over 30 days.
Measured: 30 days
Secondary outcomes (13)
Proportion of participants with any recorded serious adverse events
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 30 days
Proportion of participants that develop hypoxia (measured as peripheral oxygen saturation of less than 93% using a participant self-recorded pulse oximeter).
Measured: 30 days
Length of time from treatment initiation to sustained meaningful clinical improvement.
Measured: 30 days
Length of time from treatment initiation to initial clinical recovery.
Measured: 30 days
Length of time from treatment initiation to sustained clinical recovery.
Measured: 30 days
Proportion of participants requiring hospitalization.
Measured: 30 days
Proportion of participants with COVID-19 signs/symptoms.
Measured: 30 days
Proportion of participants with COVID-19 signs/symptoms
Measured: 60 days
Proportion of participants who have expired.
Measured: 30 days
Proportion of participants who have expired.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start4 Nov 2021
- Primary completionDec 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 598 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eyecheck, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rama D Jager, MD, Principal investigator, Eyecheck, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046561
- Sponsor's protocol ID
- STRI12
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2021
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05046561
- Acronym / sponsor ID
- STRI12
- Conditions
- Covid19
- Keywords
- Covid-19 symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 598 participants (estimated)
- Lead sponsor
- Eyecheck, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the safety of STRI Formula
- To assess the efficacy of STRI Formula in reduction of time to COVID-19 sustained symptom improvement
- To assess the efficacy of STRI Formula in reduction of time to COVID-19 initial symptom resolution
- To assess the efficacy of STRI Formula in reduction of time to COVID-19 sustained symptom resolution
- To assess the efficacy of STRI Formula in reduction in need for hospitalization
- To assess the efficacy of STRI Formula in reduction in rates of fever
- To assess the efficacy of STRI Formula in reduction in rates of hypoxia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STRI Formula | Active comparator | Drug: STRI FormulaSTRI Formula 3 capsules by mouth twice daily for 10 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 3 capsules by mouth twice daily for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
- 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):
- Ability to self-measure and self-report body temperature, and peripheral oxygen saturation (with STRI provided thermometer and STRI provided pulse oximeter).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRI FormulaSTRI 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 | Drug | STRI Formula |
| PlaceboPlacebo oral capsule | Drug | Placebo |
Primary outcome
Length of time from treatment initiation to initial meaningful clinical improvement as measured over 30 days.
Time frame: 30 days
13 secondary outcomes
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rama D Jager, MD principal investigator
Eyecheck, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STRI Formula in people with Covid19, run by Eyecheck, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rama D Jager, MD (7086204608, rama.jager@eyecheck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time from treatment initiation to initial meaningful clinical improvement as measured over 30 days. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.