QuadraMune(TM) for Prevention of COVID-19

Last updated: June 5, 2020
Sponsor: Therapeutic Solutions International
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronavirus

Treatment

N/A

Clinical Study ID

NCT04421391
QuadraMune002
  • Ages 18-120
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent, provided electronically via the EDC, demonstrating the subjectunderstands the procedures required for the study and the purpose of the study Male orfemale patients 18 years of age or older that are considered to be high-riskindividuals.

  • 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 controlfor the duration of the study This includes condoms with spermicide, oral birthcontrol pills, contraceptive implants, intra-uterine devices, or diaphragms. At leastone of these must be a barrier method. Subjects not of reproductive potential will beexempt (e.g. post-menopausal, surgically sterilized)

Exclusion

Exclusion Criteria:

  • Refusal to provide informed consent Any previous positive test for COVID-19 by RT-PCRSymptomatic for COVID-19 Diarrhea prior to the start of treatment Type I or IIdiabetes Atherosclerotic Coronary Artery Disease Any contraindication for treatment with hydroxychloroquine including: Hypoglycemia G6PD deficiency Porphyria Anemia Neutropenia Alcoholism Myasthenia GravisSkeletal muscle disorder Maculopathy Changes in the visual field Liver disease, withALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal Psoriasis Anycomorbidities which, in the opinion of the investigator, constitute health risk for thesubject.

Study Design

Total Participants: 500
Study Start date:
June 08, 2020
Estimated Completion Date:
November 08, 2020

Study 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.

Connect with a study center

  • Therapeutic Solutions International

    Oceanside, California 92056
    United States

    Active - Recruiting

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