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Completed

NCT Number: NCT04335084

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Hydroxychloroquine

Drug

Prophylaxis treatment for COVID-19

Other names: Plaquenil

Vitamin C

Dietary Supplement

Prophylaxis treatment for COVID-19

Vitamin D

Dietary Supplement

Prophylaxis treatment for COVID-19

Zinc

Dietary Supplement

Prophylaxis treatment for COVID-19

Primary outcomes

  1. Prevention of COVID-19 symptoms as recorded in a daily diary

    Time frame: 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.

  2. Safety as determined by presence or absence of Adverse Events and Serious Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ProgenaBiome

Other

Collaborators

  • DSCS CRO

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

Acronym: HELPCOVID-19

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Apr 6, 2020
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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