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

Gangnam Severance Hospital

Overview

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."

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Contact Person From COVID-19 Confirmed Patient

Interventions

Hydroxychloroquine as post exposure prophylaxisDRUG

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

Others(No intervention)OTHER

No treatment. Close monitoring and quarantine.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Gangnam Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

The rate of COVID-19

After postexposure prophylaxis, the rate of COVID-19 conversion between two groups

Time frame: PCR test of COVID-19 at 14 days after the contact from confirmed case

Data from ClinicalTrials.gov

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