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)

NCT ID: NCT04590274

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19 SARS (Severe Acute Respiratory Syndrome)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine

Vitamins and Minerals

Intervention Type DIETARY_SUPPLEMENT

elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin

Azithromycin

Intervention Type DRUG

Azithromycin

Interventions

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Hydroxychloroquine

Hydroxychloroquine

Intervention Type DRUG

Vitamins and Minerals

elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin

Intervention Type DIETARY_SUPPLEMENT

Azithromycin

Azithromycin

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Brain Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Philip DeFina, PhD

Chief Executive Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip DeFina, PhD

Role: PRINCIPAL_INVESTIGATOR

International Brain Research Foundation

Other Identifiers

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CTP-HCQ-COVID19

Identifier Type: -

Identifier Source: org_study_id

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