Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection

NCT04527614 | Completed DMC

• 1 other identifier: PICOV2021
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human; SARS Virus; COVID-19; Espiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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.

  up to 8 months

• Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection

  up to 8 months

Study Arms (2)

COVID+

OTHER

Participants with a previous SARS-CoV-2 infection

Diagnostic Test: qRT-PCR and serology

COVID-

OTHER

Participants without a previous SARS-CoV-2 infection

Diagnostic Test: qRT-PCR and serology

Interventions

qRT-PCR and serology DIAGNOSTIC_TEST

qRT-PCR and serology

COVID+; COVID-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sciensano: lead
• Mensura EDPB: collaborator
• Institute of Tropical Medicine, Belgium: collaborator
• Université Libre de Bruxelles: collaborator

Study Sites (1)

Sciensano

Brussels, 1050, Belgium

Location

Related Publications (1)

• 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.

  PMID: 36997386 DERIVED

MeSH Terms

Conditions

Influenza, Human; Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 26, 2020
• Study Start: September 24, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

BE (1)