Vitamin C Drug Action
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 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 :
- 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.
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| 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
| 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.
| 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 |
| 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 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 |
Source: https://clinicaltrials.gov/ct2/show/NCT04335084
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