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| Name | Class |
|---|---|
| Mensura EDPB | UNKNOWN |
| Institute of Tropical Medicine, Belgium | OTHER |
| Université Libre de Bruxelles | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID+ | Other | Participants with a previous SARS-CoV-2 infection |
|
| COVID- | Other | Participants without a previous SARS-CoV-2 infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| qRT-PCR and serology | Diagnostic Test | qRT-PCR and serology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls | 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. | up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sciensano | Brussels | 1050 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36997386 | Derived | Pannus P, Depickere S, Kemlin D, Georges D, Houben S, Olislagers V, Waegemans A, De Craeye S, Francotte A, Chaumont F, Van Oostveldt C, Heyndrickx L, Michiels J, Willems E, Dhondt E, Krauchuk M, Schmickler MN, Verbrugghe M, Van Loon N, Dierick K, Matagne A, Desombere I, Arien KK, Marchant A, Goossens ME. Third dose of COVID-19 mRNA vaccine closes the gap in immune response between naive nursing home residents and healthy adults. Vaccine. 2023 Apr 24;41(17):2829-2836. doi: 10.1016/j.vaccine.2023.03.047. Epub 2023 Mar 27. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| 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. | Disease severity will be measured by hospitalization and mortality | up to 8 months |
| Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection | up to 8 months |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |