Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Overview

Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.

Full Title of Study: “Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2021

Interventions

  • Drug: Hydroxychloroquine
    • Hydroxychloroquine
  • Dietary Supplement: Vitamins and Minerals
    • elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin
  • Drug: Azithromycin
    • Azithromycin

Arms, Groups and Cohorts

  • Experimental: Regimen
    • 0-400 mg Hydroxychloroquine 0-500 mg Azithromycin 0-50 mg elemental Zinc 0-3,000 mg Vitamin C 0-5,000 IU Vitamin D3 0-1200 mg N-acetylcysteine 0-600 mg Elderberry 0-600 mg Quercetin

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of individuals who develop COVID-19 symptoms
    • Time Frame: 6 months from study start
    • The investigators will compare what percentage of participants in this study go on to develop COVID-19 symptoms, as compared to individuals not on the medicational regimen in this study.

Participating in This Clinical Trial

Inclusion Criteria

1) Patients must have one or more of the following: 1. confirmed diagnosis of active SARS-CoV-2 infection, diagnosed with PCR 2. continued close contact with an individual with suspected SARS-CoV-2 infection 3. at risk for SARS-CoV-2 infection in the opinion of the treating physician or Principal Investigator. Exclusion Criteria:

1) Patients must not have any uncontrolled disease such as: 1. cardiovascular disease 2. hepatic disease 3. renal disease 4. metabolic disease 5. other diseases or insufficiencies

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • International Brain Research Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Philip DeFina, PhD, Chief Executive Officer – International Brain Research Foundation
  • Overall Official(s)
    • Philip DeFina, PhD, Principal Investigator, International Brain Research Foundation
  • Overall Contact(s)
    • Philip DeFina, PhD, 7324947600, pdefina@ibrfinc.org

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