A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

Conditions
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COVID-19, Coronavirus Infection, Sars-CoV2, Corona Virus Infection, COVID, Coronavirus, Coronavirus-19, Coronavirus 19

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Dietary Supplement: Vitamin C
* Dietary Supplement: Vitamin D
* Dietary Supplement: Zinc


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This study will focus on medical workers who at elevated risk of COVID-19 due to exposure to positive patients in the Emergency Department or Intensive Care Unit
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Workers<br>Medical workers who are exposed to COVID-19 and as such are at higher risk for infection. | Drug: Hydroxychloroquine<br>* Prophylaxis treatment for COVID-19<br>* Other names: Plaquenil;Dietary Supplement: Vitamin C<br>* Prophylaxis treatment for COVID-19<br>Dietary Supplement: Vitamin D<br>* Prophylaxis treatment for COVID-19<br>Dietary Supplement: Zinc<br>* Prophylaxis treatment for COVID-19<br>|
| Placebo Comparator: Placebo<br>Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection | Dietary Supplement: Vitamin C<br>* Prophylaxis treatment for COVID-19<br>Dietary Supplement: Vitamin D<br>* Prophylaxis treatment for COVID-19<br>Dietary Supplement: Zinc<br>* Prophylaxis treatment for COVID-19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of COVID-19 symptoms as recorded in a daily diary | 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. | 24 weeks | 
| Safety as determined by presence or absence of Adverse Events and Serious Adverse Events | 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. | 24 weeks |