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

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

Non Recruiting
18 years and older
All
Phase 2

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Overview

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

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.

Eligibility

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.
    1. 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

Study details
    COVID-19
    Coronavirus Infection
    Sars-CoV2
    Corona Virus Infection
    COVID
    Coronavirus
    Coronavirus-19
    Coronavirus 19

NCT04335084

ProgenaBiome

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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