Covid19 Clinical Trial
Official title:
Phase II Study of QuadraMune(TM) for Prevention of COVID-19 in High Risk Populations
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | November 8, 2020 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Therapeutic Solutions International | Oceanside | California |
Lead Sponsor | Collaborator |
---|---|
Therapeutic Solutions International |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevention of COVID-19 | Prevention of COVID-19 symptoms as recorded in a daily diary | 12 Weeks | |
Secondary | 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. | 12 Weeks |
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