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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335084
• Other study ID #: PRG-042
• Status: Recruiting
• Phase: Phase 2
• Start date: June 22, 2020
• Est. completion date: July 2025

Study information

• Verified date: October 2021
• Source: ProgenaBiome
• Contact: Sabine Hazan, MD
• Phone: 805-339-0549
• Email: drsabinehazan[@]progenabiome.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus
• Coronavirus 19
• Coronavirus Infection
• Coronavirus Infections
• Coronavirus-19
• COVID
• COVID-19
• Infections
• Sars-CoV2

Intervention

Drug:
• Hydroxychloroquine
Prophylaxis treatment for COVID-19

Dietary Supplement:
• Vitamin C
Prophylaxis treatment for COVID-19
• Vitamin D
Prophylaxis treatment for COVID-19
• Zinc
Prophylaxis treatment for COVID-19

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
ProgenaBiome	DSCS CRO

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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