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.
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
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
ProgenaBiome
Ventura, California, United States
Investigator: Sabine Hazan, MD
Contact: 805-339-0549
drsabinehazan@progenabiome.com
Investigator: Sabine Hazan, MD
Sabine Hazan, MD
805-339-0549
drsabinehazan@progenabiome.com
Jordan Daniels, MS
217-494-6692
jordan@progenabiome.com
Sabine Hazan, MD, Principal Investigator
ProgenaBiome