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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sciensano
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/
- •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.
Arms & Interventions
COVID+
Participants with a previous SARS-CoV-2 infection
Intervention: qRT-PCR and serology (Diagnostic Test)
COVID-
Participants without a previous SARS-CoV-2 infection
Intervention: qRT-PCR and serology (Diagnostic Test)
Outcomes
Primary Outcomes
Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls
Time Frame: 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 Outcomes
- Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.(up to 8 months)
- Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection(up to 8 months)
- Validation of (SimplySpiro) to replace nasopharyngeal swabs(up to 8 months)
- Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV(up to 8 months)
- Identify the antibody characteristics in participants with reinfection with SARS-CoV-2(up to 8 months)
Investigators
Maria Goossens
MD, PhD
Sciensano