Influenza, HumanPICOVNCT04527614
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
A study testing qRT-PCR and serology in people with Influenza, Human and SARS Virus, run by Sciensano at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, SARS Virus, COVID-19
- What is being tested?
- qRT-PCR and serology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Sep 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- qRT-PCR and serology
- Medical subject headings
- Influenza, Human, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qRT-PCR and serologyDiagnostic test
qRT-PCR and serology
| Study group | Role | What they receive |
|---|---|---|
| COVID+ | Other | Participants with a previous SARS-CoV-2 infection Receives: Diagnostic Test: qRT-PCR and serology |
| COVID- | Other | Participants without a previous SARS-CoV-2 infection Receives: Diagnostic Test: qRT-PCR and serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 months
Secondary outcomes (5)
Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV
Measured: up to 8 months
Validation of (SimplySpiro) to replace nasopharyngeal swabs
Measured: up to 8 months
Identify the antibody characteristics in participants with reinfection with SARS-CoV-2
Measured: up to 8 months
Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.
Disease severity will be measured by hospitalization and mortality
Measured: up to 8 months
Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start24 Sep 2020
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciensano
- Sponsor type
- Other government
- Collaborators
- Mensura EDPB, Institute of Tropical Medicine, Belgium, Université Libre de Bruxelles
- Responsible party
- Principal investigator, Maria Goossens, Sciensano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527614
- Sponsor's protocol ID
- PICOV2021
- Acronym
- PICOV
- Status last verified
- Mar 2023
- First submitted
- 18 Aug 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36997386
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04527614
- Acronym / sponsor ID
- PICOV / PICOV2021
- Conditions
- Influenza, Human, SARS Virus, COVID-19, Espiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- SciensanoOther government
- Collaborators
- Mensura EDPB, Institute of Tropical Medicine, Belgium, Université Libre de Bruxelles
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID+ | Other | Diagnostic Test: qRT-PCR and serologyParticipants with a previous SARS-CoV-2 infection |
| COVID- | Other | Diagnostic Test: qRT-PCR and serologyParticipants without a previous SARS-CoV-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qRT-PCR and serologyqRT-PCR and serology | Diagnostic test | COVID+, COVID- |
Primary outcome
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.
5 secondary outcomes
Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV
Time frame: up to 8 months
Validation of (SimplySpiro) to replace nasopharyngeal swabs
Time frame: up to 8 months
Identify the antibody characteristics in participants with reinfection with SARS-CoV-2
Time frame: up to 8 months
Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.
Time frame: up to 8 months
Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection
Time frame: up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 36997386Pannus 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qRT-PCR and serology in people with Influenza, Human and SARS Virus, run by Sciensano at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.