COVID-19 Among Healthcare Workers in Belgian Hospitals

NCT04373889 | Completed

• 1 other identifier: Sciensano
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

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

Keywords

SARS-CoV-2; COVID-19; Hospital healthcare workers; Belgium; Pandemic 2020; Hospital

Outcome Measures

Primary Outcomes (8)

• Change of prevalence of COVID-19 infection among Belgian active hospital healthcare workers (HCW)

  Change in the percentage of HCW with positive RT-qPCR test on nasopharyngeal swabs among all HCW tested

  "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"

• Change of prevalence of COVID-19 infection among Belgian active hospital healthcare workers (HCW)

  Change in the absolute number of HCW with positive RT-qPCR test on nasopharyngeal swabs among the total number of all HCW tested

  "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"

• Change of seroprevalence of SARS-CoV-2 among Belgian active hospital HCW

  Change in percentage of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among all HCW tested

  "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"

• Change of seroprevalence of SARS-CoV-2 among Belgian active hospital HCW

  Change in the absolute number of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among the total number of all HCW tested

  "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"

• Change in new cases (incidence) of COVID-19 among Belgian hospital HCW

  Change in the percentage of HCW with positive RT-qPCR test on nasopharyngeal swabs among all HCW tested detected at each of the study follow-up testing points that did not have a positive RT-qPCR test before.

  "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"

• Change in new cases (incidence) of COVID-19 among Belgian hospital HCW

  Change in absolute number of HCW with positive RT-qPCR test on nasopharyngeal swabs among the total number of HCW tested detected at each of the study follow-up testing points that did not have a positive RT-qPCR test before.

  "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"

• Change in SARS-CoV-2 seroconversion among Belgian hospital HCW

  Change in the percentage of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among all HCW tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.

  "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"

• Change in SARS-CoV-2 seroconversion among Belgian hospital HCW

  Change in the absolute number of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among the total number of HCW tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.

  "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"

Secondary Outcomes (6)

• Sensitivity and specificity of serological tests

  "Month 3"

• Sensitivity and specificity of saliva sampling method (sampling with Oracol or equivalent)

  "Month 3"

• Validate the nasal swab against the standard

  "Month 3"

• Potential risk factors for the infection

  "Month 5" and "Month 12"

• The proportion of asymptomatic cases among new cases that develop during a period of 12 months

  "Month 5" and "Month 12"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population include health care workers currently working in Belgian hospitals. According to current national guidelines, HCW in contact with persons at risk for COVID-19 experiencing mild respiratory symptoms without fever are allowed to work if clinical condition permits, while wearing a mask and observing usual hygiene measures. Healthcare workers experiencing respiratory symptoms and fever are systematically tested and if positive, isolated at home, if negative, eventually working wearing a mask if the clinical state allows it. Those who recovered from a documented infection are also allowed to work. HCW who are not in contact with persons at risk for COVID-19 are not tested and systematically isolated in case of any unusual respiratory symptom. This implies that at baseline, the study population will only include asymptomatic or paucisymptomatic HCW applying proper infection prevention measures.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sciensano: lead
• Institute of Tropical Medicine, Belgium: collaborator

Study Sites (1)

Sciensano

Brussels, 1050, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34187832 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: May 5, 2020
• Study Start: April 22, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)