Back to resultsQuadraMune(TM) for Prevention of COVID-19
Primary Purpose
Covid19, Coronavirus, SARS-CoV 2
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
QuadraMune(TM)
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Immunology, Innate Immune System
Eligibility 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.
Sites / Locations
- Therapeutic Solutions InternationalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks
Outcomes
Primary Outcome Measures
Prevention of COVID-19
Prevention of COVID-19 symptoms as recorded in a daily diary
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04421391
First Posted
June 4, 2020
Last Updated
June 5, 2020
Sponsor
Therapeutic Solutions International
1. Study Identification
Unique Protocol Identification Number
NCT04421391
Brief Title
QuadraMune(TM) for Prevention of COVID-19
Official Title
Phase II Study of QuadraMune(TM) for Prevention of COVID-19 in High Risk Populations
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2020 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 8, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutic Solutions International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Coronavirus, SARS-CoV 2
Keywords
Immunology, Innate Immune System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
QuadraMune(TM)
Intervention Description
QuadraMune(TM) is a commercially available nutritional supplement
Primary Outcome Measure Information:
Title
Prevention of COVID-19
Description
Prevention of COVID-19 symptoms as recorded in a daily diary
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Safety as determined by presence or absence of Adverse Events and Serious Adverse Events
Description
Assessment of adverse events and serious adverse events will be performed.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas E Ichim, Ph.D
Phone
18583534303
Email
thomas.ichim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Veltmeyer, MD
Organizational Affiliation
Therapeutic Solutions International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Therapeutic Solutions International
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas E Ichim
Phone
858-353-4303
Email
thomas.ichim@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
QuadraMune(TM) for Prevention of COVID-19
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