QuadraMune(TM) for Prevention of COVID-19
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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
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Condition or disease | Intervention/treatment | Phase |
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Covid19 Coronavirus SARS-CoV 2 | Dietary Supplement: QuadraMune(TM) | Not Applicable |
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 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 |

Arm | Intervention/treatment |
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Experimental: Treatment Arm
Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks
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Dietary Supplement: QuadraMune(TM)
QuadraMune(TM) is a commercially available nutritional supplement |
- Prevention of COVID-19 [ Time Frame: 12 Weeks ]Prevention of COVID-19 symptoms as recorded in a daily diary
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Contact: Thomas E Ichim, Ph.D | 18583534303 | thomas.ichim@gmail.com |
United States, California | |
Therapeutic Solutions International | Recruiting |
Oceanside, California, United States, 92056 | |
Contact: Thomas E Ichim 858-353-4303 thomas.ichim@gmail.com |
Principal Investigator: | James Veltmeyer, MD | Therapeutic Solutions International |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Immunology Innate Immune System |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |