Coronavirus, Coronavirus 19, Coronavirus-19, Coronavirus Infection, Corona Virus Infection, COVID, COVID-19, Sars-CoV2
Conditions
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.
Interventions
DRUGHydroxychloroquine
Prophylaxis treatment for COVID-19
DIETARY_SUPPLEMENTVitamin C
Prophylaxis treatment for COVID-19
DIETARY_SUPPLEMENTVitamin D
Prophylaxis treatment for COVID-19
DIETARY_SUPPLEMENTZinc
Prophylaxis treatment for COVID-19
Sponsors
DSCS CRO
ProgenaBiome
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This study will focus on medical workers who at elevated risk of COVID-19 due to exposure to positive patients in the Emergency Department or Intensive Care Unit
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed