Status:
UNKNOWN
QuadraMune(TM) for Prevention of COVID-19
Lead Sponsor:
Therapeutic Solutions International
Conditions:
Covid19
Coronavirus
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
QuadraMune(TM) is a nutritional supplement which has previously been demonstrated to possess antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies. The current cl...
Detailed Description
QuadraMune(TM) is composed of 4 natural ingredients. Pterostilbene is an analogue of resveratrol, and has been shown to possess antiinflammatory activity. Additionally, this compound suppresses macro...
Eligibility Criteria
Inclusion
- Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study Male or female patients 18 years of age or older that are considered to be high-risk individuals.
- High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities.
- Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
Exclusion
- Refusal to provide informed consent Any previous positive test for COVID-19 by RT-PCR Symptomatic for COVID-19 Diarrhea prior to the start of treatment Type I or II diabetes Atherosclerotic Coronary Artery Disease
- Any contraindication for treatment with hydroxychloroquine including:
- Hypoglycemia G6PD deficiency Porphyria Anemia Neutropenia Alcoholism Myasthenia Gravis Skeletal muscle disorder Maculopathy Changes in the visual field Liver disease, with ALT/AST \> 2.5 upper limit normal and total bilirubin \>2.5 upper limit normal Psoriasis Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 8 2020
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04421391
Start Date
June 8 2020
End Date
November 8 2020
Last Update
June 9 2020
Active Locations (1)
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1
Therapeutic Solutions International
Oceanside, California, United States, 92056