NCT04845880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 13, 2021

Last Update Submit

April 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 patients in Our Hospital

    Determining antibody levels and seroprevalence of healthy healthcare workers

    6 months

Study Arms (1)

SARS Cov_2 Incidence of Healthy Health Workers

OTHER
Diagnostic Test: Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2

Interventions

Blood level of spike protein (S) or the nucleocapsid (N) of SARS-CoV-2

SARS Cov_2 Incidence of Healthy Health Workers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana Dr. Turgut Noyan Application and Research Center

Adana, Turkey (Türkiye)

Location

Related Publications (2)

  • Yang W, Cao Q, Qin L, Wang X, Cheng Z, Pan A, Dai J, Sun Q, Zhao F, Qu J, Yan F. Clinical characteristics and imaging manifestations of the 2019 novel coronavirus disease (COVID-19):A multi-center study in Wenzhou city, Zhejiang, China. J Infect. 2020 Apr;80(4):388-393. doi: 10.1016/j.jinf.2020.02.016. Epub 2020 Feb 26.

    PMID: 32112884BACKGROUND
  • Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

    PMID: 31986261BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 15, 2021

Study Start

October 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations