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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04590274
Recruitment Status : Withdrawn (Investigative Team no longer interested)
First Posted : October 19, 2020
Last Update Posted : December 7, 2021
Information provided by (Responsible Party):
Philip DeFina, PhD, International Brain Research Foundation

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
Covid19 SARS (Severe Acute Respiratory Syndrome) Drug: Hydroxychloroquine Dietary Supplement: Vitamins and Minerals Drug: Azithromycin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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)
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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

Primary Outcome Measures :
  1. 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.

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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT04590274

Sponsors and Collaborators
International Brain Research Foundation
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Principal Investigator: Philip DeFina, PhD International Brain Research Foundation
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Responsible Party: Philip DeFina, PhD, Chief Executive Officer, International Brain Research Foundation Identifier: NCT04590274    
Other Study ID Numbers: CTP-HCQ-COVID19
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021

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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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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents