A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
NCT ID: NCT04335084
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2020-06-22
2024-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Hydroxychloroquine
Prophylaxis treatment for COVID-19
Vitamin C
Prophylaxis treatment for COVID-19
Vitamin D
Prophylaxis treatment for COVID-19
Zinc
Prophylaxis treatment for COVID-19
Placebo
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
Vitamin C
Prophylaxis treatment for COVID-19
Vitamin D
Prophylaxis treatment for COVID-19
Zinc
Prophylaxis treatment for COVID-19
Interventions
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Hydroxychloroquine
Prophylaxis treatment for COVID-19
Vitamin C
Prophylaxis treatment for COVID-19
Vitamin D
Prophylaxis treatment for COVID-19
Zinc
Prophylaxis treatment for COVID-19
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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DSCS CRO
INDUSTRY
ProgenaBiome
OTHER
Responsible Party
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Principal Investigators
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Sabine Hazan, MD
Role: PRINCIPAL_INVESTIGATOR
ProgenaBiome
Locations
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ProgenaBiome
Ventura, California, United States
Countries
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References
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Banjanac M, Munic Kos V, Nujic K, Vrancic M, Belamaric D, Crnkovic S, Hlevnjak M, Erakovic Haber V. Anti-inflammatory mechanism of action of azithromycin in LPS-stimulated J774A.1 cells. Pharmacol Res. 2012 Oct;66(4):357-62. doi: 10.1016/j.phrs.2012.06.011. Epub 2012 Jul 3.
Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.
Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.
Other Identifiers
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PRG-042
Identifier Type: -
Identifier Source: org_study_id
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