Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers (SeCo)

University Medicine Greifswald

Status: Completed

Conditions: SARS-CoV-2

Treatments: Diagnostic Test: Serum testing; Diagnostic Test: Nasal swab

Study type: Observational

Funder types: Other

Identifiers

NCT04370119

BB 068/20

Details and patient eligibility

About

The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccination effects

Full description

This study aims to collect information on staff working at the Greifswald University hospital.

Over a 5 year period, a maximum of 12 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) and/or blood samples (to assess immunological responses, e.g. for SARS-CoV-2 antibody testing) will be collected. This will help to gain a better understanding of viral load and immunological responses, e.g. antibody development and their effects over time.

At study visit 2 - 12, participants will also be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, impact of the pandemic on their quality of life, their interest in getting a SARS-CoV-2 vaccine/their SARS-CoV-2 vaccination status and vaccination side effects).

The remaining blood samples will be stored in a repository for future research.

The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.

Enrollment: 1,092 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. >= 18 years of age
2. Willing and able to complete a written consent form
3. Willing to have blood samples stored for future research
4. Healthcare worker employed at Greifswald University Hospital

Exclusion criteria

1. < 18 years of age
2. Decline to participate

Trial design

1,092 participants in 3 patient groups

(1) Healthcare workers

Description:

All healthcare workers at University Medicine Greifswald who were enrolled in the study between 04/2020-08/2020

Treatment:

Diagnostic Test: Nasal swab

Diagnostic Test: Serum testing

(2) Healthcare workers in high-risk areas of the hospital (intensive care, emergency medicine)

Description:

Healthcare workers at University Medicine Greifswald who were enrolled in the study between 01/2021-03/2021

Treatment:

Diagnostic Test: Nasal swab

Diagnostic Test: Serum testing

(3) Healthcare workers after SARS-CoV-2 vaccination

Description:

Healthcare workers at University Medicine Greifswald who received a SARS-CoV-2 vaccination within the last 7-21 days

Treatment:

Diagnostic Test: Nasal swab

Diagnostic Test: Serum testing