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)

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04590274
• Other study ID #: CTP-HCQ-COVID19
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 2020
• Est. completion date: December 2021

Study information

• Verified date: December 2021
• Source: International Brain Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Covid19
• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine

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

Drug:
• Azithromycin
Azithromycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
International Brain Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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