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

Launched by PROGENABIOME · Apr 2, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether a combination of hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can help prevent COVID-19 symptoms in high-risk individuals. The study is currently active, but it is not recruiting new participants. It is open to adults aged 18 and older who work in healthcare settings, such as hospitals and clinics, and are considered at higher risk of exposure to the virus. Participants must be willing to use effective birth control methods during the study.

If you qualify and choose to participate, you will receive the study treatments and will be monitored for any symptoms or side effects. It’s important to note that individuals who have previously tested positive for COVID-19 or who are showing symptoms cannot participate. Additionally, those with certain medical conditions or who are taking specific medications may also be excluded for safety reasons. This trial aims to find out if these treatments can effectively prevent COVID-19, which could be valuable in managing the pandemic.

Gender

ALL

Eligibility 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