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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 : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Tracking Information
First Submitted Date  ICMJE April 2, 2020
First Posted Date  ICMJE April 6, 2020
Last Update Posted Date May 12, 2020
Estimated Study Start Date  ICMJE May 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • Prevention of COVID-19 measured by negative testing with RT-PCR [ Time Frame: 24 weeks ]
    To determine if treatment with these therapies in combination can prevent COVID-19
  • Safety as determined by blood pressure readings [ Time Frame: 24 weeks ]
    To determine the safety of these therapies in combination
  • Safety as determined by presence of side effects [ Time Frame: 24 weeks ]
    To assess the presence or absence of side effects, and whether they are tolerable.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • COVID-19
  • Coronavirus Infection
  • Sars-CoV2
  • Corona Virus Infection
  • COVID
  • Coronavirus
  • Coronavirus-19
  • Coronavirus 19
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Medical Workers
    Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
    Interventions:
    • Drug: Hydroxychloroquine
    • Dietary Supplement: Vitamin C
    • Dietary Supplement: Vitamin D
    • Dietary Supplement: Zinc
  • Placebo Comparator: Placebo
    Medical workers how are exposed to COVID-19 and as such are at a higher risk for infection
    Interventions:
    • Dietary Supplement: Vitamin C
    • Dietary Supplement: Vitamin D
    • Dietary Supplement: Zinc
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 217-494-6692 msjordandaniels@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04335084
Other Study ID Numbers  ICMJE PRG-042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ProgenaBiome
Study Sponsor  ICMJE ProgenaBiome
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sabine Hazan, MD ProgenaBiome
PRS Account ProgenaBiome
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP