QuadraMune(TM) for Prevention of COVID-19

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    Therapeutic Solutions International
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Updated on 19 February 2024
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covid-19
oral contraceptives

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 clinical trial aims to assess in a 500 volunteer trial the efficacy of QuadraMune(TM) in reducing infection in individuals at high risk of COVID-19.

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 macrophage activation while enhancing NK activity.

Epigallocatechin gallate (EGCG) is one of the active ingredients in green tea and has been shown to act as an activator of T cells, and a suppressor of neutrophil mediated inflammation.

Sulforaphane is derived from broccoli and studies have shown that it protects lungs from inflammatory pathology.

Thymoquinone, which is chemically related to hydroxychloroquine, possessing antiviral effects and increases NK activity.

QuadraMune is a combination of these ingredients and is believed to possess superior in vitro and in vivo therapeutic properties as compared to when the ingredients are administered individually.

The study aims to assess preventative effects of QuadraMune(TM) administration for 12 weeks.

Details
Condition Coronavirus, COVID19, SARS-CoV 2
Age 18years - 120years
Treatment QuadraMune(TM)
Clinical Study IdentifierNCT04421391
SponsorTherapeutic Solutions International
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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