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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

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
Coronavirus Infections

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.

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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 : August 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


Group/Cohort
healthcare personnel group
healthcare worker who was exposed to confirmed MERS patients, irrespective of adequate personal protective equipment.



Primary Outcome Measures :
  1. IgG(+) [ Time Frame: up to 4-5 month ]
    MERS-CoV IgG(+)


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
1. Healthcare-personnel
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497885


Locations
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Korea, Republic of
Ewha womans university mokdong hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University Mokdong Hospital
Investigators
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Principal Investigator: Hee Jung Choi, MD, PhD Ewha Womans University Mokdong Hospital
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Responsible Party: Hee Jung Choi, Professor, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT02497885    
Other Study ID Numbers: KMSG_HCW_IgG
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Keywords provided by Hee Jung Choi, Ewha Womans University Mokdong Hospital:
MERS
healthcare personnel
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases