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)

NCT04590274 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: CTP-HCQ-COVID19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19; SARS (Severe Acute Respiratory Syndrome)

Outcome Measures

Primary Outcomes (1)

• Percentage of individuals who develop COVID-19 symptoms

  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.

  6 months from study start

Study Arms (1)

Regimen

EXPERIMENTAL

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; Drug: Azithromycin

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine

Regimen

Vitamins and Minerals DIETARY_SUPPLEMENT

elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin

Regimen

Azithromycin DRUG

Azithromycin

Regimen

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) Patients must not have any uncontrolled disease such as:
• cardiovascular disease
• hepatic disease
• renal disease
• metabolic disease
• other diseases or insufficiencies

Sponsors & Collaborators

• International Brain Research Foundation: lead

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Hydroxychloroquine; Vitamins; Minerals; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Inorganic Chemicals; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Philip DeFina, PhD

  International Brain Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Executive Officer

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12