Back to resultsSafety 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)
Primary Purpose
Covid19, SARS (Severe Acute Respiratory Syndrome)
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hydroxychloroquine
Vitamins and Minerals
Azithromycin
Sponsored by
About this trial
This is an interventional prevention trial for Covid19
Eligibility Criteria
Inclusion Criteria:
1) 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:
1) Patients must not have any uncontrolled disease such as:
- cardiovascular disease
- hepatic disease
- renal disease
- metabolic disease
- other diseases or insufficiencies
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Regimen
Arm 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04590274
First Posted
October 7, 2020
Last Updated
December 5, 2021
Sponsor
International Brain Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04590274
Brief 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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Investigative Team no longer interested
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Brain Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS (Severe Acute Respiratory Syndrome)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regimen
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamins and Minerals
Intervention Description
elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin
Primary Outcome Measure Information:
Title
Percentage of individuals who develop COVID-19 symptoms
Description
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.
Time Frame
6 months from study start
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1) 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:
1) Patients must not have any uncontrolled disease such as:
cardiovascular disease
hepatic disease
renal disease
metabolic disease
other diseases or insufficiencies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip DeFina, PhD
Organizational Affiliation
International Brain Research Foundation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
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)
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