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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)

Conditions
-----------------
Contact Person From COVID-19 Confirmed Patient

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine as post exposure prophylaxis
* Other: Others(No intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: administration of hydroxychloroquine as PEP<br> | Drug: Hydroxychloroquine as post exposure prophylaxis<br>* 1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po<br>|
| Active Comparator: control with no PEP<br> | Other: Others(No intervention)<br>* No treatment. Close monitoring and quarantine.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of COVID-19 | After postexposure prophylaxis, the rate of COVID-19 conversion between two groups | PCR test of COVID-19 at 14 days after the contact from confirmed case | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Postexposure prophylaxis, hydroxychloroquine, COVID-19