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

Recruiting
COVID-19
Coronavirus Infection
SARS-COV2
Corona Virus Infection
COVID
Coronavirus
Coronavirus-19
Coronavirus 19

Drug: Hydroxychloroquine

Prophylaxis treatment for COVID-19
Other Name: Plaquenil

Dietary Supplement: Vitamin C

Prophylaxis treatment for COVID-19

Dietary Supplement: Vitamin D

Prophylaxis treatment for COVID-19

Dietary Supplement: Zinc

Prophylaxis treatment for COVID-19

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

ProgenaBiome
Ventura, California, United States

Investigator: Sabine Hazan, MD
Contact: 805-339-0549
drsabinehazan@progenabiome.com

Investigator: Sabine Hazan, MD

Contacts

Sabine Hazan, MD
805-339-0549
drsabinehazan@progenabiome.com

Jordan Daniels, MS
217-494-6692
jordan@progenabiome.com

Sabine Hazan, MD, Principal Investigator
ProgenaBiome

NCT Number
MeSH Terms
Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Vitamin D
Vitamins
Hydroxychloroquine