Status:
COMPLETED
A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
Lead Sponsor:
ProgenaBiome
Collaborating Sponsors:
DSCS CRO
Conditions:
COVID-19
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
Detailed Description
In this study, subjects will take a regimen of hydroxychloroquine, vitamin C, vitamin D, and Zinc to test if this combination can prevent COVID-19. Treatment with hydroxychlorquine will last 1 day. Tr...
Eligibility Criteria
Inclusion
- 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.
- a. 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
- 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 contraindicated medications found in Appendix 2
- Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.
- Vaccination for SARS-CoV-2
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04335084
Start Date
June 22 2020
End Date
April 11 2024
Last Update
June 5 2025
Active Locations (1)
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1
ProgenaBiome
Ventura, California, United States, 93003