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)

International Brain Research Foundation (Other)
Overall Status
Withdrawn ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Actual Enrollment :
0 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
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)
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Hydroxychloroquine

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

Drug: Azithromycin

Outcome Measures

Primary Outcome Measures

  1. Percentage of individuals who develop COVID-19 symptoms [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.

Eligibility Criteria


Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • International Brain Research Foundation


  • Principal Investigator: Philip DeFina, PhD, International Brain Research Foundation

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Philip DeFina, PhD, Chief Executive Officer, International Brain Research Foundation Identifier:
Other Study ID Numbers:
First Posted:
Oct 19, 2020
Last Update Posted:
Dec 7, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2021