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

NCT04335084 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: PRG-042
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19; Coronavirus Infection; Sars-CoV2; Corona Virus Infection; COVID; Coronavirus; Coronavirus-19; Coronavirus 19

Outcome Measures

Primary Outcomes (2)

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

  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.

  24 weeks

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

  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.

  24 weeks

Study Arms (2)

Medical Workers

EXPERIMENTAL

Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.

Drug: Hydroxychloroquine; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc

Placebo

PLACEBO COMPARATOR

Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection

Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc

Interventions

Hydroxychloroquine DRUG

Prophylaxis treatment for COVID-19

Also known as: Plaquenil

Medical Workers

Vitamin C DIETARY_SUPPLEMENT

Prophylaxis treatment for COVID-19

Medical Workers; Placebo

Vitamin D DIETARY_SUPPLEMENT

Prophylaxis treatment for COVID-19

Medical Workers; Placebo

Zinc DIETARY_SUPPLEMENT

Prophylaxis treatment for COVID-19

Medical Workers; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ProgenaBiome: lead
• DSCS CRO: collaborator

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Related Publications (5)

• 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.

  PMID: 22766077 BACKGROUND

• 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.

  PMID: 32173110 BACKGROUND

• 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.

  PMID: 32074550 BACKGROUND

• 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.

  PMID: 32205204 BACKGROUND

• 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.

  PMID: 32052466 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine; Ascorbic Acid; Vitamin D; Zinc

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will focus on medical workers who at elevated risk of COVID-19 due to exposure to positive patients in the Emergency Department or Intensive Care Unit

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: June 22, 2020
• Primary Completion: May 31, 2022
• Study Completion: April 11, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)