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

ProgenaBiome

Status and phase: Active, not recruiting; Phase 2

Conditions: Sars-CoV2; COVID-19; Corona Virus Infection; Coronavirus 19; COVID; Coronavirus-19; Coronavirus; Coronavirus Infection

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Vitamin C; Dietary Supplement: Zinc; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04335084

PRG-042

Details and patient eligibility

About

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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600 participants in 2 patient groups, including a placebo group

Medical Workers

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine

Dietary Supplement: Zinc

Dietary Supplement: Vitamin C

Dietary Supplement: Vitamin D

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Zinc

Dietary Supplement: Vitamin C

Dietary Supplement: Vitamin D