COVID-19, Espiratory Tract Infections, Influenza, Human, SARS Virus
Conditions
Brief summary
Background: Each Belgian winter season is characterized by a wave of influenza like and respiratory symptoms. Especially, the elderly people are more vulnerable to be infected by influenza, but also RSV. The recent COVID-19 pandemic and eventually a next wave, will increase the prevalence of influenza like and respiratory symptoms. Method: A multicentre non-commercial cohort study will be conducted in nursing home staff and residents during the Winter season 2020-2021. Objectives: Primary objective is the difference in incidence of influenza like and respiratory symptoms between cases (cases have evidence of past infection with SARS-CoV-2, referred to as Covid +) and controls (controls have no evidence of previous infection and are referred to as Covid -). The primary outcome analysis as well as the secondary outcome analyses will use two strata: nursing home staff and nursing home residents. The secondary objectives are the difference in incidence of COVID-19, influenza, RSV infections confirmed by PCR between cases and controls, to define a correlate of protection in the covid + group against re-infection with SARS-CoV-2 based on the study of the pre-existing antibody profile (antigen specificity, antibody type and antibody level) at the time of re-exposure. A multiplex assay will be used to assess the antibody profile. Finally, to study the COVID-19 disease severity (7 point WHO ordinal scale, this includes a.o. hospitalisation, mechanical ventilation need and ICU admission, mortality) based on the presence/absence of pre-existing antibodies and the pre-existing antibody profile. For other respiratory infections we will study the need for hospitalization and mortality.
Interventions
DIAGNOSTIC_TESTqRT-PCR and serology
qRT-PCR and serology
Sponsors
Mensura EDPB
Institute of Tropical Medicine, Belgium
Université Libre de Bruxelles
Sciensano
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Being a staff member or resident from te participating nursing homes * The subject should be aged 18 years or older, have a Belgian National Number and be insured by a Belgian sickness fund. * All subjects that are cognitively capable to give consent themselves to participate in the study.
Exclusion criteria
* Insufficient knowledge of the Dutch or French language. * Residents with a previous diagnosis of dementia having a mini-mental state examination (MMSE) below 18/30. * Participants which life-expectancy is less than the time of the study. * Staff members not expected to continue working at the nursing home during the winter season. * Participants for whom veins are not accessible for simple periphery blood puncture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls | up to 8 months | This study will assess the time to the occurrence of influenza-like illness (ILI) or acute respiratory infection (ARI) in subjects previously COVID+ compared to subjects known as COVID- (controls), more specifically subjects will belong to two subgroups: nursing home residents (65+) and nursing home staff (18-65y). COVID+ is defined as a past SARS-CoV-2 infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV | up to 8 months | — |
| Validation of (SimplySpiro) to replace nasopharyngeal swabs | up to 8 months | — |
| Identify the antibody characteristics in participants with reinfection with SARS-CoV-2 | up to 8 months | — |
| Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity. | up to 8 months | Disease severity will be measured by hospitalization and mortality |
| Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection | up to 8 months | — |
Countries
Belgium
Outcome results
None listed