COVID-19 Among Healthcare Workers in Belgian Hospitals

NCT ID: NCT04373889

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 850 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-22
• Study Completion Date: 2021-04-30

Brief Summary

Due to the situation this study, originally planted until September 2020, was extended with 7 months until April 2021. This extension was approved by the ethical committee University hospital Ghent, Belgium.

The novel SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated Coronavirus type 2) is rapidly spreading over the world causing a condition called Coronavirus disease 2019 (COVID-19). Hospital health care workers (HCW) have received detailed instructions to protect themselves against this infection, but it is likely that at least some of the HCW will get infected either at their workplace or elsewhere. It would be useful to document prevalence and seroprevalence of SARS-CoV-2 and their monthly evolution among Belgian active hospital HCW during a period of 12 months starting beginning of April 2020 and the number of new cases (incidence) of COVID-19 and SARS-CoV-2 seroconversions among Belgian hospital HCW during a period of 12 months which are the primary objectives of this study.

Additionally the study will validate serological tests (subject to change/addition depending on the evolution of scientific research) against the plaque reduction neutralization test (PRNT) (gold standard); validate the saliva sample (sampling with Oracol or equivalent) against the standard naso/oro pharyngeal swabbing (NOPS) to perform RT-qPCR for SARS-CoV-2 diagnostic purposes, as well as against the standard serology (serum); validate the nasal swab against the standard (NOPS) to perform RT-qPCR for SARS-CoV-2 for diagnostic purposes; investigate potential risk factors for the infection; quantify the proportion of asymptomatic cases among new cases that develop during a period of 12 months.

To reach these primary and secondary objectives the researchers will conduct a prospective cohort study in which a random selection of HCW currently working in Belgian hospitals will be tested monthly (with for the first month an additional testing point at 14 days). The testing will include four kind of laboratory tests, being; a molecular (PCR) test on a nasopharyngeal, a saliva and nasal sample (for nasal and saliva sample only testing until 50 PCR positive and 50 PCR negative samples are collected) and a serological test for which a blood sample is needed. To asses risk factors, at each testing point a questionnaire providing basic socio-demographic and health characteristics of the HCW including presence of symptoms since the previous testing point and the HCW's involvement in caring for COVID-19 patients will be completed.

Laboratory data and epidemiological data (questionnaire) will be collected simultaneously. In each of the participating hospitals, one contact person will be designated to coordinate the study locally (ideally a staff member of the local infection and prevention control team) and communicate with the researchers. The sample size calculation indicated the inclusion of 17 randomly selected Belgian hospitals and in each hospital 50 randomly selected HCW. HCW can only be enrolled in the study after give a written informed consent.

Laboratory testing will be performed at the Virology Diseases and Immune Response services of Sciensano, Ukkel, and the Virology Laboratory of the Institute of Tropical Medicine, Antwerp. The laboratory test results will be communicated by the laboratory to each participant. Each participant and sample will have a unique code assigned. Data collected through the questionnaire will be send psuedonymised (using the unique code) to the epidemiologist at Sciensano. The laboratory will prepare a list of test results by unique code to be linked for further analysis with the questionnaire data. None of the researchers who will analyse the data will be involved in data collection, nor in the care of COVID-19 patients.

This study is a Belgian multicentric study executed by Sciensano, Brussels, in collaboration with the Institute of Tropical Medicine, Antwerp.

Conditions

SARS-CoV-2; COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Any permanent medical and paramedical staff working in the hospital who provided a signed informed consent to participate in the study.
• Participants must have a social security insurance (mandatory in Belgium).
• This study only include adults.

Exclusion Criteria

• Staff hired on a temporary (interim) basis will be excluded as follow-up over time will be compromised.
• Administrative staff or technical staff will also be excluded.
• HCW who were not active during the inclusion period will automatically be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: collaborator

Sciensano

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sciensano

Brussels, , Belgium

Countries

Belgium

References

Mortgat L, Verdonck K, Hutse V, Thomas I, Barbezange C, Heyndrickx L, Fischer N, Vuylsteke B, Kabouche I, Arien KK, Desombere I, Duysburgh E. Prevalence and incidence of anti-SARS-CoV-2 antibodies among healthcare workers in Belgian hospitals before vaccination: a prospective cohort study. BMJ Open. 2021 Jun 29;11(6):e050824. doi: 10.1136/bmjopen-2021-050824.

Reference Type: DERIVED

PMID: 34187832 (View on PubMed)

Other Identifiers

Sciensano

Identifier Type: -

Identifier Source: org_study_id