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Seroprevalence of MERS-CoV IgG in Healthcare Workers

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ClinicalTrials.gov Identifier: NCT02497885
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Hee Jung Choi, Ewha Womans University Mokdong Hospital

Tracking Information
First Submitted Date July 6, 2015
First Posted Date July 15, 2015
Last Update Posted Date October 30, 2015
Study Start Date August 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2015)
IgG(+) [ Time Frame: up to 4-5 month ]
MERS-CoV IgG(+)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Seroprevalence of MERS-CoV IgG in Healthcare Workers
Official Title Seroprevalence of IgG Antibodies to Middle East Respiratory Syndrome Coronavirus in Asymptomatic Healthcare Workers After Treatment of Confirmed MERS Patient
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum
Sampling Method Non-Probability Sample
Study Population 1. Healthcare-personnel
Condition Coronavirus Infections
Intervention Not Provided
Study Groups/Cohorts healthcare personnel group
healthcare worker who was exposed to confirmed MERS patients, irrespective of adequate personal protective equipment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 29, 2015)
737
Original Estimated Enrollment
 (submitted: July 12, 2015)
632
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02497885
Other Study ID Numbers KMSG_HCW_IgG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hee Jung Choi, Ewha Womans University Mokdong Hospital
Study Sponsor Ewha Womans University Mokdong Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Hee Jung Choi, MD, PhD Ewha Womans University Mokdong Hospital
PRS Account Ewha Womans University Mokdong Hospital
Verification Date October 2015