Seroprevalence of MERS-CoV IgG in Healthcare Workers

NCT ID: NCT02497885

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

737 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-10-31

Brief Summary

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The investigators aim to do serosurvey of healthcare-personnel who had participated in treatment of confirmed patients of Middle-East respiratory syndrome. The investigators collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and will collect the post-exposure serum from about 25-30 centers in which confirmed MERS patients had been treated.

The investigators will deduct the seroprevalence of MERS-CoV IgG among the healthy healthcare-personnel, and calculate the sero-conversion rate if possible. The investigators will subdivided the seroprevalence according to the degree of exposure and preparedness of personal protective equipment.

Detailed Description

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We aim to deduct the seroprevalence of healthcare-personnel (HCP) who had participated in treatment of confirmed patients of Middle-East respiratory syndrome.

In first step, we collected the base-line (pre-exposure) serum from the HCP who worked in the hospitals in which confirmed MERS patients were treated. Pre-exposure serum was collected in a few centers. If the serum was drawn within 3 weeks from initial exposure, then the serum was considered adequate as pre-exposure. (Because, antibody against the MERS-CoV would be produced after more the 17-21 days of exposure). The serum was frozen.

In second step, we will collect the post-exposure serum from the HCP who worked in the hospitals in which confirmed MERS patients were treated or detected. We plan to include 25-30 centers. The timing of sample collection is 6-8 weeks after last contact with confirmed MERS patients. The serum will also freeze.

In third step, we will assay the presence of antibody in collected sample. We will use MERS-CoV ELISA kit (EUROIMMUNE co.) as screening test and MERS-CoV IFA kit (EUROIMMUNE co.) as confirm test.

Conditions

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Coronavirus Infections

Keywords

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MERS healthcare personnel

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthcare personnel group

healthcare worker who was exposed to confirmed MERS patients, irrespective of adequate personal protective equipment.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthcare-personnel who are working for hospitals in which confirmed MERS patients were treated or detected
* Close contact with confirmed patient(s).
* Agree to informed consent

Exclusion Criteria

* disagree to consent
* confirmed MERS patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee Jung Choi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Jung Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha womans university mokdong hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KMSG_HCW_IgG

Identifier Type: -

Identifier Source: org_study_id