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

Phase 3

Withdrawn

• Conditions: Contact Person From COVID-19 Confirmed Patient
• Interventions: Other: Others(No intervention); Drug: Hydroxychloroquine as post exposure prophylaxis

• Registration Number: NCT04330144
• Lead Sponsor: Gangnam Severance Hospital

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."

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-31
• Study Start: 2020-04-01
• Study First Posted: 2020-04-01
• Primary Completion: 2020-06-29
• Study Completion: 2020-06-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control with no PEP	Others(No intervention)	-
administration of hydroxychloroquine as PEP	Hydroxychloroquine as post exposure prophylaxis	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of