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

NCT ID: NCT04527614

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

COVID+

Participants with a previous SARS-CoV-2 infection

Group Type: OTHER

qRT-PCR and serology

Intervention Type: DIAGNOSTIC_TEST

qRT-PCR and serology

COVID-

Participants without a previous SARS-CoV-2 infection

Group Type: OTHER

qRT-PCR and serology

Intervention Type: DIAGNOSTIC_TEST

qRT-PCR and serology

Interventions

qRT-PCR and serology

qRT-PCR and serology

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mensura EDPB

UNKNOWN

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: collaborator

Université Libre de Bruxelles

OTHER

Sponsor Role: collaborator

Sciensano

OTHER_GOV

Sponsor Role: lead

Responsible Party

Maria Goossens

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sciensano

Brussels, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 36997386 (View on PubMed)

Other Identifiers

PICOV2021

Identifier Type: -

Identifier Source: org_study_id