Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)

NCT ID: NCT04330144

Last Updated: 2021-08-09

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-06-29

Brief Summary

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There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2.

* 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."

Detailed Description

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Conditions

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Contact Person From COVID-19 Confirmed Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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administration of hydroxychloroquine as PEP

Group Type EXPERIMENTAL

Hydroxychloroquine as post exposure prophylaxis

Intervention Type DRUG

1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po

control with no PEP

Group Type ACTIVE_COMPARATOR

Others(No intervention)

Intervention Type OTHER

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

Intervention Type DRUG

Others(No intervention)

No treatment. Close monitoring and quarantine.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A contact person from confirmed case of SARS-CoV-2 infection
* 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

* Hypersensitivity to Chloroquine or Hydroxychloroquine
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Goo Song

Professor, Department of Internal Medicine,

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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South Korea

Other Identifiers

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3-2020-0036

Identifier Type: -

Identifier Source: org_study_id

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