Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection (PICOV)
Primary Purpose
Influenza, Human, SARS Virus, COVID-19
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
qRT-PCR and serology
Sponsored by
About this trial
This is an interventional diagnostic trial for Influenza, Human
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.
Sites / Locations
- Sciensano
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
COVID+
COVID-
Arm Description
Participants with a previous SARS-CoV-2 infection
Participants without a previous SARS-CoV-2 infection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV
Validation of (SimplySpiro) to replace nasopharyngeal swabs
Identify the antibody characteristics in participants with reinfection with SARS-CoV-2
Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.
Disease severity will be measured by hospitalization and mortality
Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection
Full Information
NCT ID
NCT04527614
First Posted
August 18, 2020
Last Updated
March 27, 2023
Sponsor
Sciensano
Collaborators
Mensura EDPB, Institute of Tropical Medicine, Belgium, Université Libre de Bruxelles
1. Study Identification
Unique Protocol Identification Number
NCT04527614
Brief Title
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
Acronym
PICOV
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sciensano
Collaborators
Mensura EDPB, Institute of Tropical Medicine, Belgium, Université Libre de Bruxelles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, SARS Virus, COVID-19, Espiratory Tract Infections
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID+
Arm Type
Other
Arm Description
Participants with a previous SARS-CoV-2 infection
Arm Title
COVID-
Arm Type
Other
Arm Description
Participants without a previous SARS-CoV-2 infection
Intervention Type
Diagnostic Test
Intervention Name(s)
qRT-PCR and serology
Intervention Description
qRT-PCR and serology
Primary Outcome Measure Information:
Title
Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls
Description
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.
Time Frame
up to 8 months
Secondary Outcome Measure Information:
Title
Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV
Time Frame
up to 8 months
Title
Validation of (SimplySpiro) to replace nasopharyngeal swabs
Time Frame
up to 8 months
Title
Identify the antibody characteristics in participants with reinfection with SARS-CoV-2
Time Frame
up to 8 months
Title
Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.
Description
Disease severity will be measured by hospitalization and mortality
Time Frame
up to 8 months
Title
Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection
Time Frame
up to 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Sciensano
City
Brussels
ZIP/Postal Code
1050
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
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