search
Back to results

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

Primary Purpose

COVID-19, Coronavirus Infection, Sars-CoV2

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Vitamin C
Vitamin D
Zinc
Sponsored by
ProgenaBiome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ProgenaBiomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Medical Workers

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2020
Last Updated
October 19, 2021
Sponsor
ProgenaBiome
Collaborators
DSCS CRO
search

1. Study Identification

Unique Protocol Identification Number
NCT04335084
Brief Title
A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
Acronym
HELPCOVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProgenaBiome
Collaborators
DSCS CRO

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Coronavirus Infection, Sars-CoV2, Corona Virus Infection, COVID, Coronavirus, Coronavirus-19, Coronavirus 19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical Workers
Arm Type
Experimental
Arm Description
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Intervention Description
Prophylaxis treatment for COVID-19
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
Prophylaxis treatment for COVID-19
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Prophylaxis treatment for COVID-19
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
Prophylaxis treatment for COVID-19
Primary Outcome Measure Information:
Title
Prevention of COVID-19 symptoms as recorded in a daily diary
Description
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.
Time Frame
24 weeks
Title
Safety as determined by presence or absence of Adverse Events and Serious Adverse Events
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Hazan, MD
Phone
805-339-0549
Email
drsabinehazan@progenabiome.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Daniels, MS
Phone
217-494-6692
Email
jordan@progenabiome.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD
Organizational Affiliation
ProgenaBiome
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProgenaBiome
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD
Phone
805-339-0549
Email
drsabinehazan@progenabiome.com
First Name & Middle Initial & Last Name & Degree
Jordan Daniels, MS
Phone
805-339-0549
Email
jordan@progenabiome.com
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22766077
Citation
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.
Results Reference
background
PubMed Identifier
32173110
Citation
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.
Results Reference
background
PubMed Identifier
32074550
Citation
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.
Results Reference
background
PubMed Identifier
32205204
Citation
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. 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.
Results Reference
background
PubMed Identifier
32052466
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs