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

Phase 2

Recruiting

• Conditions: COVID-19; Sars-CoV2; Corona Virus Infection; Coronavirus Infection; Coronavirus 19; COVID; Coronavirus; Coronavirus-19
• Interventions: Drug: Hydroxychloroquine; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc

• Registration Number: NCT04335084
• Lead Sponsor: ProgenaBiome

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.

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Study Start: 2020-06-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-21
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medical Workers	Hydroxychloroquine	Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Medical Workers	Vitamin C	Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Medical Workers	Vitamin D	Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Medical Workers	Zinc	Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Placebo	Vitamin C	Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
Placebo	Vitamin D	Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
Placebo	Zinc	Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection

Primary Outcome Measures

Name	Time	Method
Safety as determined by presence or absence of Adverse Events and Serious Adverse Events	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	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.

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States