Clinical trial NCT04527614: Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
Official title: Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection (PICOV) A Multicentre Academic Prospective Cohort Study in Nursing Home During the Winter Season 2020-2021
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
SARS Virus
COVID-19
Espiratory Tract Infections
Lead sponsor: Sciensano
Sponsor class: OTHER_GOV
Collaborators: name: Mensura EDPB
name: Institute of Tropical Medicine, Belgium
name: Université Libre de Bruxelles
First posted: 2020-08-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls
timeFrame: up to 8 months
Secondary outcomes:
measure: Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV
timeFrame: up to 8 months
measure: Validation of (SimplySpiro) to replace nasopharyngeal swabs
timeFrame: up to 8 months
measure: Identify the antibody characteristics in participants with reinfection with SARS-CoV-2
timeFrame: up to 8 months
measure: Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.
timeFrame: up to 8 months
measure: Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sciensano
Study officials:
References: