Coronavirus InfectionsNCT02497885
Seroprevalence of MERS-CoV IgG in Healthcare Workers
An observational study of Coronavirus Infections, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections
- How many people
- 737 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Healthcare-personnel
Who may be able to join
- 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
Who cannot join
- disagree to consent
- confirmed MERS patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of IgG Antibodies to Middle East Respiratory Syndrome Coronavirus in Asymptomatic Healthcare Workers After Treatment of Confirmed MERS Patient
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.
Read the 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.
- Conditions
- Coronavirus Infections
- Keywords
- MERS, healthcare personnel
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthcare personnel group | healthcare worker who was exposed to confirmed MERS patients, irrespective of adequate personal protective equipment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG(+)
MERS-CoV IgG(+)
Measured: up to 4-5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Jung Choi, Ewha Womans University Mokdong Hospital
- Investigators
- Hee Jung Choi, MD, PhD, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497885
- Sponsor's protocol ID
- KMSG_HCW_IgG
- Status last verified
- Oct 2015
- First submitted
- 6 Jul 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of IgG Antibodies to Middle East Respiratory Syndrome Coronavirus in Asymptomatic Healthcare Workers After Treatment of Confirmed MERS Patient
- ClinicalTrials.gov ID
- NCT02497885
- Acronym / sponsor ID
- KMSG_HCW_IgG
- Conditions
- Coronavirus Infections
- Keywords
- MERS, healthcare personnel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthcare personnel group | – | –healthcare worker who was exposed to confirmed MERS patients, irrespective of adequate personal protective equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Healthcare-personnel
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- disagree to consent
- confirmed MERS patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IgG(+)
Time frame: up to 4-5 month
MERS-CoV IgG(+)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Jung Choi, MD, PhD principal investigator
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG(+) (time frame: up to 4-5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.