Seroprevalence of MERS-CoV IgG in Healthcare Workers

Completed

• Conditions: Coronavirus Infections

• Registration Number: NCT02497885
• Lead Sponsor: Ewha Womans University Mokdong Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-12
• Study First Posted: 2015-07-15
• Study Start: 2015-08
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 737

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

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Exclusion Criteria

• disagree to consent
• confirmed MERS patient

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IgG(+)	up to 4-5 month	MERS-CoV IgG(+)

Trial Locations

Locations (1)

Ewha womans university mokdong hospital; 🇰🇷 Seoul, Korea, Republic of