NCT04370119

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

Screening for SARS-CoV-2-Infections and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,092 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Nasal swab	SARS-CoV-2 PCR
DIAGNOSTIC_TEST	Serum testing	Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination

Timeline

• Start date: 2020-04-27
• Primary completion: 2021-04-23
• Completion: 2025-04-27
• First posted: 2020-04-30
• Last updated: 2025-11-20

Locations

1 site across 1 country: Germany