Vitamin C And Zinc Side Effects

Vitamin C And Zinc Side Effects

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.

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Study Type :	Interventional  (Clinical Trial)
Estimated 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 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 :	June 22, 2020
Estimated Primary Completion Date :	December 2024
Estimated Study Completion Date :	July 2025

Resource links provided by the National Library of Medicine

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 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
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

Primary Outcome Measures :

1. 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.

   
   
2. 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.

   
   

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335084

Contacts

Locations

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United States, California
ProgenaBiome	Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com
Principal Investigator: Sabine Hazan, MD

Sponsors and Collaborators

ProgenaBiome

DSCS CRO

Investigators

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Principal Investigator:	Sabine Hazan, MD	ProgenaBiome

Publications:

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.

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Responsible Party:	ProgenaBiome
ClinicalTrials.gov Identifier:	NCT04335084
Other Study ID Numbers:	PRG-042
First Posted:	April 6, 2020    Key Record Dates
Last Update Posted:	October 21, 2021
Last Verified:	October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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:

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Infections Communicable Diseases COVID-19 Coronavirus Infections Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases	Vitamin D Vitamins Ascorbic Acid Hydroxychloroquine Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Antioxidants

Vitamin C And Zinc Side Effects

Source: https://clinicaltrials.gov/ct2/show/NCT04335084