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.
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.
Dietary Supplement: QuadraMune(TM)
QuadraMune(TM) is a commercially available nutritional supplement
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.
Therapeutic Solutions International
Oceanside, California, United States
Investigator: Thomas E Ichim
Contact: 858-353-4303
thomas.ichim@gmail.com
Thomas E Ichim, Ph.D
18583534303
thomas.ichim@gmail.com
James Veltmeyer, MD, Principal Investigator
Therapeutic Solutions International