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

• Sponsor: ProgenaBiome (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04335084
• Collaborator: DSCS CRO (Industry)
• Enrollment: 600
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60.3
• Patients Per Site Per Month: 10

Study Details

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

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

• Study Type: Interventional
• Anticipated 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 UnitThis 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: Jun 22, 2020
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

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 Names: 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

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

1. High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities.

1. 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:

8. Hypoglycemia

9. G6PD deficiency

10. Porphyria

11. Anemia

12. Neutropenia

13. Alcoholism

14. Myasthenia Gravis

15. Skeletal muscle disorder

16. Maculopathy

17. Changes in the visual field

18. Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal

19. Psoriasis

20. Any contraindicated medications found in Appendix 2

21. Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.

22. Vaccination for SARS-CoV-2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProgenaBiome	Ventura	California	United States	93003

Sponsors and Collaborators

• ProgenaBiome
• DSCS CRO

Investigators

• Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

• Banjanac M, Munić Kos V, Nujić K, Vrančić M, Belamarić D, Crnković S, Hlevnjak M, Eraković 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.
• 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.
• 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.
• Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honoré S, Colson P, Chabrière 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.
• 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.

• Responsible Party: ProgenaBiome
• ClinicalTrials.gov Identifier: NCT04335084
• Other Study ID Numbers: PRG-042
• First Posted: Apr 6, 2020
• Last Update Posted: Oct 21, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Vitamin D; Vitamins; Ascorbic Acid; Hydroxychloroquine

Study Results

No Results Posted as of Oct 21, 2021