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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335084
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : October 21, 2021
Sponsor:
Collaborator:
DSCS CRO
Information provided by (Responsible Party):
ProgenaBiome

Study Description
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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

Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus Infection Sars-CoV2 Corona Virus Infection COVID Coronavirus Coronavirus-19 Coronavirus 19 Drug: Hydroxychloroquine Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
 Drug: Hydroxychloroquine
Prophylaxis treatment for COVID-19
Other Name: Plaquenil

Dietary Supplement: Vitamin C
Prophylaxis treatment for COVID-19

Dietary Supplement: Vitamin D
Prophylaxis treatment for COVID-19

Dietary Supplement: Zinc
Prophylaxis treatment for COVID-19
Placebo Comparator: Placebo
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
 Dietary Supplement: Vitamin C
Prophylaxis treatment for COVID-19

Dietary Supplement: Vitamin D
Prophylaxis treatment for COVID-19

Dietary Supplement: Zinc
Prophylaxis treatment for COVID-19


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

    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:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335084


Contacts
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Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 217-494-6692 jordan@progenabiome.com

Locations
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United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
DSCS CRO
Investigators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome
More Information
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Publications:

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04335084    
Other Study ID Numbers: PRG-042
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Vitamin D
Vitamins
Hydroxychloroquine
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents