COVID-19: Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04330144

Collaborator

(none)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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."

Condition or Disease	Intervention/Treatment	Phase
Contact Person From COVID-19 Confirmed Patient	Drug: Hydroxychloroquine as post exposure prophylaxis Other: Others(No intervention)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Jun 29, 2020

Actual Study Completion Date :

Jun 29, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: administration of hydroxychloroquine as PEP

Drug: Hydroxychloroquine as post exposure prophylaxis

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

Active Comparator: control with no PEP

Other: Others(No intervention)

No treatment. Close monitoring and quarantine.

Outcome Measures

Primary Outcome Measures

The rate of COVID-19 [PCR test of COVID-19 at 14 days after the contact from confirmed case]
After postexposure prophylaxis, the rate of COVID-19 conversion between two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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