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

Status and phase: Withdrawn; Phase 1

Conditions: SARS (Severe Acute Respiratory Syndrome); Covid19

Treatments: Dietary Supplement: Vitamins and Minerals; Drug: Azithromycin; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04590274

CTP-HCQ-COVID19

Details and patient eligibility

About

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.

Sex: All

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Regimen

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine

Drug: Azithromycin

Dietary Supplement: Vitamins and Minerals