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SARS Cov_2 Incidence of Healthy Health Workers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04845880
Recruitment Status : Completed
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborators:
Hikmet Eda Aliskan
Hatice Hale Gumus
Ilker Odemis
Zuhal Ekici Unsal
Information provided by (Responsible Party):
Hasan Yesilagac, Baskent University

Study Description
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Brief Summary:
Since the severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) first emerged in Wuhan, China, on 12 December 2019, it has spread rapidly across the world and developed into a pandemic. The pandemic has affected over 100 countries and regions, with over 132 million confirmed cases of COVID-19. The rapid spread of SARS-CoV-2 has caused considerable harm to public health and the economy. Alongside other laboratory tests and clinical findings of the COVID-19 infection, serological testing may be beneficial for epidemiological monitoring and outbreak control. The determination of antibodies enables confirmation of the SARS-CoV-2 infection in asymptomatic patients in addition to those with typical symptoms. In this study, we aimed to determine the SARS-CoV-2 seroprevalence and the IgG antibody levels among healthcare workers who frequently encountered COVID-19 patients in our hospital.

Condition or disease Intervention/treatment Phase
SARS COV-2 IgG Levels on Health Workers Diagnostic Test: Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 Patients in Our Hospital
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
SARS Cov_2 Incidence of Healthy Health Workers Diagnostic Test: Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
Blood level of spike protein (S) or the nucleocapsid (N) of SARS-CoV-2


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 patients in Our Hospital [ Time Frame: 6 months ]
    Determining antibody levels and seroprevalence of healthy healthcare workers


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy Health Workers - SARS COV-2 PCR (-)

Exclusion Criteria:

Health Workers - SARS COV-2 PCR (+) Pregnancy Autoimmune diseases Received immunosuppressive therapy

Contacts and Locations
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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): NCT04845880


Locations
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Turkey
Adana Dr. Turgut Noyan Application and Research Center
Adana, Turkey
Sponsors and Collaborators
Baskent University
Hikmet Eda Aliskan
Hatice Hale Gumus
Ilker Odemis
Zuhal Ekici Unsal
More Information
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Publications:

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Responsible Party: Hasan Yesilagac, Specialist Doctor, Baskent University
ClinicalTrials.gov Identifier: NCT04845880    
Other Study ID Numbers: KA20/449
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myeloma Proteins
Paraproteins
Immunologic Factors
Physiological Effects of Drugs