Trials / Completed
CompletedNCT04527614
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (actual)
- Sponsor
- Sciensano · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | qRT-PCR and serology | qRT-PCR and serology |
Timeline
- Start date
- 2020-09-24
- Primary completion
- 2022-11-30
- Completion
- 2022-12-31
- First posted
- 2020-08-26
- Last updated
- 2023-03-30
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04527614. Inclusion in this directory is not an endorsement.