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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04527614
Recruitment Status : Enrolling by invitation
First Posted : August 26, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Mensura EDPB
Institute of Tropical Medicine, Belgium
Université Libre de Bruxelles
Information provided by (Responsible Party):
Maria Gpossens, Sciensano

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.


Condition or disease Intervention/treatment Phase
Influenza, Human SARS Virus COVID-19 Espiratory Tract Infections Diagnostic Test: qRT-PCR and serology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
COVID+
Participants with a previous SARS-CoV-2 infection
Diagnostic Test: qRT-PCR and serology
qRT-PCR and serology

COVID-
Participants without a previous SARS-CoV-2 infection
Diagnostic Test: qRT-PCR and serology
qRT-PCR and serology




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV [ Time Frame: up to 8 months ]
  2. Validation of (SimplySpiro) to replace nasopharyngeal swabs [ Time Frame: up to 8 months ]
  3. Identify the antibody characteristics in participants with reinfection with SARS-CoV-2 [ Time Frame: up to 8 months ]
  4. Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity. [ Time Frame: up to 8 months ]
    Disease severity will be measured by hospitalization and mortality

  5. Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection [ Time Frame: up to 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527614


Locations
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Belgium
Sciensano
Brussels, Belgium, 1050
Sponsors and Collaborators
Sciensano
Mensura EDPB
Institute of Tropical Medicine, Belgium
Université Libre de Bruxelles
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Responsible Party: Maria Gpossens, MD, PhD, Sciensano
ClinicalTrials.gov Identifier: NCT04527614    
Other Study ID Numbers: PICOV2021
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases