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

ProgenaBiome254 enrolled

Overview

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

254

Conditions

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

Interventions

HydroxychloroquineDRUG

Prophylaxis treatment for COVID-19

Vitamin CDIETARY_SUPPLEMENT

Prophylaxis treatment for COVID-19

Vitamin DDIETARY_SUPPLEMENT

Prophylaxis treatment for COVID-19

Zinc

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study 2. 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. 3. 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: 1. Refusal to provide informed consent 2. Any previous positive test for COVID-19 by RT-PCR 3. Symptomatic for COVID-19 4. Diarrhea prior to the start of treatment 5. Type I or II diabetes 6. Atherosclerotic Coronary Artery Disease 7. Any contraindication for treatment with hydroxychloroquine including: 1. Hypoglycemia 2. G6PD deficiency 3. Porphyria 4. Anemia 5. Neutropenia 6. Alcoholism 7. Myasthenia Gravis 8. Skeletal muscle disorder 9. Maculopathy 10. Changes in the visual field 11. Liver disease, with ALT/AST \> 2.5 upper limit normal and total bilirubin \>2.5 upper limit normal 12. Psoriasis 13. Any contraindicated medications found in Appendix 2 8. Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject. 9. Vaccination for SARS-CoV-2

Locations (1)

ProgenaBiome

Ventura, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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