A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
| Registry | NCT04335084, acronym HELPCOVID-19 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, single group, masking: double, prevention |
| Enrollment | 254 (Actual) |
| Sponsor | ProgenaBiome (Other); collaborators: DSCS CRO |
| Conditions | COVID-19, Coronavirus Infection, Sars-CoV2, Corona Virus Infection, COVID, Coronavirus, Coronavirus-19, Coronavirus 19 |
| Interventions | Hydroxychloroquine, Vitamin C, Vitamin D, Zinc (Drug, dietary supplement) |
| Dates | start 2020-06-22, primary completion 2022-05-31, completion 2024-04-11, first posted 2020-04-06, last updated 2025-06-05 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for COVID-19 All trials for Coronavirus Infection All trials of Hydroxychloroquine All trials of Vitamin C
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Medical Workers | Experimental | Drug: Hydroxychloroquine; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc | Medical workers who are exposed to COVID-19 and as such are at higher risk for infection. |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc | Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| ProgenaBiome | Ventura, California | United States |