Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
NCT ID: NCT04330144
Last Updated: 2021-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2020-04-01
2020-06-29
Brief Summary
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* Primary end point: comparison the rate of COVID-19 between PEP with HCQ and control group.
* Secondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment).
* Safety comparison: Safety verification by identifying major side effects in the HCQ group."
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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administration of hydroxychloroquine as PEP
Hydroxychloroquine as post exposure prophylaxis
1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po
control with no PEP
Others(No intervention)
No treatment. Close monitoring and quarantine.
Interventions
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Hydroxychloroquine as post exposure prophylaxis
1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po
Others(No intervention)
No treatment. Close monitoring and quarantine.
Eligibility Criteria
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Inclusion Criteria
* Medical staff exposed from confirmed case of SARS-CoV-2 infection in hospitals
* Persons exposed to SARS-CoV-2 in COVID-19 outbreak situation with certain workplaces, religious groups, and military, etc.
* Subjects of study include both symptomatic and asymptomatic contacts.
Exclusion Criteria
* Those who are contraindicated in Hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc.
* Human immunodeficiency virus (HIV) infected person
* Patients with autoimmune disease (Systemic lupus erythematosus, Mixed connective tissue disease)
* Patients with autoimmune rheumatoid inflammatory disease (AIIRD; Autoimmune inflammatory rheumatic diseases - Ankylosing spondylitis, Rheumatic arthritis, Psoriatic arthritis)
* Arrhythmia, liver cirrhosis of Child Pugh C, chronic renal failure with eGFR≤30mL / min / 1.73m2
* A person who is positive in the COVID-19 screening PCR test before starting PEP
18 Years
99 Years
ALL
Yes
Sponsors
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Gangnam Severance Hospital
OTHER
Responsible Party
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Young Goo Song
Professor, Department of Internal Medicine,
Principal Investigators
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Yong Goo Song, Professor
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Locations
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Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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3-2020-0036
Identifier Type: -
Identifier Source: org_study_id
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