Clinical trial NCT04370119: Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers
Official title: Screening for SARS-CoV-2-Infections and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: SARS-CoV-2
Keywords: Serology
antibody formation
epidemiology
immunity
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Friedrich Loefler Institute for Animal Health
name: EUROIMMUN AG
First posted: 2020-04-30
Enrollment: 1092
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health Care Worker

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of people with detectable antibodies to SARS-CoV-2
timeFrame: 1 year
Secondary outcomes:
measure: Number of people with detectable SARS-CoV-2 nucleic acid
timeFrame: First study visit (baseline)
Other outcomes:
measure: Number of people with detectable antibodies to SARS-CoV-2
timeFrame: First study visit (baseline)
measure: Number of people with detectable antibodies to SARS-CoV-2
timeFrame: 2 years
measure: Number of people with detectable antibodies to SARS-CoV-2
timeFrame: 3 years
measure: Number of people with detectable antibodies to SARS-CoV-2
timeFrame: 4 years
measure: Number of people with detectable antibodies to SARS-CoV-2
timeFrame: 5 years
measure: Number of people with detectable SARS-CoV-2 nucleic acid
timeFrame: 2 years
measure: Number of people with detectable SARS-CoV-2 nucleic acid
timeFrame: 3 years
measure: Number of people with detectable SARS-CoV-2 nucleic acid
timeFrame: 4 years
measure: Number of people with detectable SARS-CoV-2 nucleic acid
timeFrame: 5 years
measure: SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects
timeFrame: 1 year
measure: SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects
timeFrame: 2 years
measure: SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects
timeFrame: 3 years
measure: SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects
timeFrame: 4 years
measure: SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects
timeFrame: 5 years
measure: Serological changes after SARS-CoV-2 vaccination
timeFrame: 7 days to 6 months after vaccination
Locations:
city: Greifswald
country: Germany
facility: Greifswald University Medicine
Study officials:
affiliation: University Medicine Greifswald
name: Nils-Olaf Hübner, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald
name: Karsten Becker, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handtke S, Wolff M, Zaninetti C, Wesche J, Schonborn L, Aurich K, Ulm L, Hubner NO, Becker K, Thiele T, Greinacher A. A flow cytometric assay to detect platelet-activating antibodies in VITT after ChAdOx1 nCov-19 vaccination. Blood. 2021 Jul 1;137(26):3656-3659. doi: 10.1182/blood.2021012064.