Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2020-06-08
2020-11-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks
QuadraMune(TM)
QuadraMune(TM) is a commercially available nutritional supplement
Interventions
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QuadraMune(TM)
QuadraMune(TM) is a commercially available nutritional supplement
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
120 Years
ALL
Yes
Sponsors
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Therapeutic Solutions International
INDUSTRY
Responsible Party
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Principal Investigators
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James Veltmeyer, MD
Role: PRINCIPAL_INVESTIGATOR
Therapeutic Solutions International
Locations
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Therapeutic Solutions International
Oceanside, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QuadraMune002
Identifier Type: -
Identifier Source: org_study_id
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