A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19, Coronavirus Infection, Sars-CoV2, Corona Virus Infection, COVID, Coronavirus, Coronavirus-19, Coronavirus 19

In brief

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

Key facts

Study ID

NCT04335084

Run by

ProgenaBiome

People needed

254

Starts

2020-06-22

Expected to finish

2024-04-11

Last updated by the study team

2025-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study
• 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.
• 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 qualify if…

• Refusal to provide informed consent
• Any previous positive test for COVID-19 by RT-PCR
• Symptomatic for COVID-19
• Diarrhea prior to the start of treatment
• Type I or II diabetes
• Atherosclerotic Coronary Artery Disease
• Any contraindication for treatment with hydroxychloroquine including:
• Hypoglycemia
• G6PD deficiency
• Porphyria
• Anemia
• Neutropenia
• Alcoholism
• Myasthenia Gravis
• Skeletal muscle disorder
• Maculopathy
• Changes in the visual field
• Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal
• Psoriasis
• Any contraindicated medications found in Appendix 2
• Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.
• Vaccination for SARS-CoV-2

Where it is running

• ProgenaBiome — Ventura, California, United States

Full record on ClinicalTrials.gov

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