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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04421391
Other study ID # QuadraMune002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 8, 2020
Est. completion date November 8, 2020

Study information

Verified date June 2020
Source Therapeutic Solutions International
Contact Thomas E Ichim, Ph.D
Phone 18583534303
Email thomas.ichim@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date November 8, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
QuadraMune(TM)
QuadraMune(TM) is a commercially available nutritional supplement

Locations

Country Name City State
United States Therapeutic Solutions International Oceanside California

Sponsors (1)

Lead Sponsor Collaborator
Therapeutic Solutions International

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevention of COVID-19 Prevention of COVID-19 symptoms as recorded in a daily diary 12 Weeks
Secondary Safety as determined by presence or absence of Adverse Events and Serious Adverse Events Assessment of adverse events and serious adverse events will be performed. 12 Weeks
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