Back to resultsHydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial) (COVID-19)
Primary Purpose
Contact Person From COVID-19 Confirmed Patient
Status
Withdrawn
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hydroxychloroquine as post exposure prophylaxis
Others(No intervention)
Sponsored by
About this trial
This is an interventional prevention trial for Contact Person From COVID-19 Confirmed Patient focused on measuring Postexposure prophylaxis, hydroxychloroquine, SARS-CoV-2, COVID-19
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
Sites / Locations
- Gangnam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
administration of hydroxychloroquine as PEP
control with no PEP
Arm Description
Outcomes
Primary Outcome Measures
The rate of COVID-19
After postexposure prophylaxis, the rate of COVID-19 conversion between two groups
Secondary Outcome Measures
Full Information
NCT ID
NCT04330144
First Posted
March 30, 2020
Last Updated
August 2, 2021
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04330144
Brief Title
Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
Acronym
COVID-19
Official Title
A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No Participants Enrolled
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
June 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Person From COVID-19 Confirmed Patient
Keywords
Postexposure prophylaxis, hydroxychloroquine, SARS-CoV-2, COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
administration of hydroxychloroquine as PEP
Arm Type
Experimental
Arm Title
control with no PEP
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine as post exposure prophylaxis
Intervention Description
1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po
Intervention Type
Other
Intervention Name(s)
Others(No intervention)
Intervention Description
No treatment. Close monitoring and quarantine.
Primary Outcome Measure Information:
Title
The rate of COVID-19
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Goo Song, Professor
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
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