Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ProgenaBiome
With
DSCS CRO
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.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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)
You may not be if
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.
