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)

Sponsor

International Brain Research Foundation (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04590274

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

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

Study Design

Study Type:

Interventional

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)

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

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

Hydroxychloroquine

Dietary Supplement: Vitamins and Minerals

elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin

Drug: Azithromycin

Azithromycin

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients must have one or more of the following:

confirmed diagnosis of active SARS-CoV-2 infection, diagnosed with PCR
continued close contact with an individual with suspected SARS-CoV-2 infection
at risk for SARS-CoV-2 infection in the opinion of the treating physician or Principal Investigator.

Exclusion Criteria:

Patients must not have any uncontrolled disease such as:

cardiovascular disease
hepatic disease
renal disease
metabolic disease
other diseases or insufficiencies

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

International Brain Research Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philip DeFina, PhD, Chief Executive Officer, International Brain Research Foundation

ClinicalTrials.gov Identifier:

NCT04590274

Other Study ID Numbers:

CTP-HCQ-COVID19

First Posted:

Oct 19, 2020

Last Update Posted:

Dec 7, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Coronavirus Infections

Severe Acute Respiratory Syndrome

Syndrome

Azithromycin

Hydroxychloroquine

Study Results

No Results Posted as of Dec 7, 2021