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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| ClinicalTrials.gov Identifier: NCT04590274 |
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Recruitment Status :
Withdrawn
(Investigative Team no longer interested)
First Posted : October 19, 2020
Last Update Posted : December 7, 2021
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Sponsor:
International Brain Research Foundation
Information provided by (Responsible Party):
Philip DeFina, PhD, International Brain Research Foundation
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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 Type : | Interventional (Clinical Trial) |
| 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) |
| Estimated Study Start Date : | November 2020 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Hydroxychloroquine
Hydroxychloroquine Dietary Supplement: Vitamins and Minerals elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin Drug: Azithromycin Azithromycin |
Primary Outcome Measures :
- Percentage of individuals who develop COVID-19 symptoms [ Time Frame: 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590274
Sponsors and Collaborators
International Brain Research Foundation
Investigators
| Principal Investigator: | Philip DeFina, PhD | International Brain Research Foundation |
| 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: | October 19, 2020 Key Record Dates |
| Last Update Posted: | December 7, 2021 |
| Last Verified: | December 2021 |
| 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 |
Additional relevant MeSH terms:
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COVID-19 Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome Disease Pathologic Processes Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Azithromycin Hydroxychloroquine Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |