A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
Overview
- Phase
- Phase 2
- Intervention
- Hydroxychloroquine
- Conditions
- COVID-19
- Sponsor
- ProgenaBiome
- Enrollment
- 254
- Locations
- 1
- Primary Endpoint
- Safety as determined by presence or absence of Adverse Events and Serious Adverse Events
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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. Treatment with vitamin C, vitamin D, and and zinc will last 12 weeks. The study will last 12 weeks.
Investigators
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.
- •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 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
- •Neutropenia
Arms & Interventions
Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Intervention: Hydroxychloroquine
Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Intervention: Vitamin C
Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Intervention: Vitamin D
Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Intervention: Zinc
Placebo
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
Intervention: Vitamin C
Placebo
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
Intervention: Vitamin D
Placebo
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
Intervention: Zinc
Outcomes
Primary Outcomes
Safety as determined by presence or absence of Adverse Events and Serious Adverse Events
Time Frame: 24 weeks
To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.
Prevention of COVID-19 symptoms as recorded in a daily diary
Time Frame: 24 weeks
Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.