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Seroprevalence of MERS-CoV IgG in Healthcare Workers

Sponsor
Ewha Womans University Mokdong Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02497885
Collaborator
(none)
737
Enrollment
1
Location
2
Duration (Months)
367.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    737 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Seroprevalence of IgG Antibodies to Middle East Respiratory Syndrome Coronavirus in Asymptomatic Healthcare Workers After Treatment of Confirmed MERS Patient
    Study Start Date :
    Aug 1, 2015
    Actual Primary Completion Date :
    Oct 1, 2015
    Actual Study Completion Date :
    Oct 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    healthcare personnel group

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

    Outcome Measures

    Primary Outcome Measures

    1. IgG(+) [up to 4-5 month]

      MERS-CoV IgG(+)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ewha womans university mokdong hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Ewha Womans University Mokdong Hospital

    Investigators

    • Principal Investigator: Hee Jung Choi, MD, PhD, Ewha Womans University Mokdong Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hee Jung Choi, Professor, Ewha Womans University Mokdong Hospital
    ClinicalTrials.gov Identifier:
    NCT02497885
    Other Study ID Numbers:
    • KMSG_HCW_IgG
    First Posted:
    Jul 15, 2015
    Last Update Posted:
    Oct 30, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Hee Jung Choi, Professor, Ewha Womans University Mokdong Hospital
    MERS
    healthcare personnel
    Additional relevant MeSH terms:
    Coronavirus Infections

    Study Results

    No Results Posted as of Oct 30, 2015