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QuadraMune(TM) for Prevention of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421391
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Therapeutic Solutions International

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Covid19 Coronavirus SARS-CoV 2 Dietary Supplement: QuadraMune(TM) Not Applicable

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of QuadraMune(TM) for Prevention of COVID-19 in High Risk Populations
Estimated Study Start Date : June 8, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 8, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks
 Dietary Supplement: QuadraMune(TM)
QuadraMune(TM) is a commercially available nutritional supplement


Outcome Measures
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Primary Outcome Measures :
  1. Prevention of COVID-19 [ Time Frame: 12 Weeks ]
    Prevention of COVID-19 symptoms as recorded in a daily diary


Secondary Outcome Measures :
  1. Safety as determined by presence or absence of Adverse Events and Serious Adverse Events [ Time Frame: 12 Weeks ]
    Assessment of adverse events and serious adverse events will be performed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421391


Contacts
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Contact: Thomas E Ichim, Ph.D 18583534303 thomas.ichim@gmail.com

Locations
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United States, California
Therapeutic Solutions International Recruiting
Oceanside, California, United States, 92056
Contact: Thomas E Ichim    858-353-4303    thomas.ichim@gmail.com   
Sponsors and Collaborators
Therapeutic Solutions International
Investigators
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Principal Investigator: James Veltmeyer, MD Therapeutic Solutions International
More Information
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Responsible Party: Therapeutic Solutions International
ClinicalTrials.gov Identifier: NCT04421391    
Other Study ID Numbers: QuadraMune002
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Therapeutic Solutions International:
Immunology
Innate Immune System
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases