Severe COVID-19CoVAPid2NCT05256511
COVID-19 and VA-LRTI: Second Versus First Wave of the Pandemic
An observational study of Severe COVID-19, run by University Hospital, Lille at 1 site in France.
Trial summary
Multicenter observational retrospective cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients from the first and the second wave of the pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe COVID-19
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2021to 1 Dec 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed SARS-CoV-2 community-acquired pneumonia and receiving invasive mechanical ventilation for more than 48h in the participating ICUs from the start of COVID pandemic are eligible for this study.
Who may be able to join
- Major (18 years and older)
- Admitted to the ICU
- Intubated and mechanically ventilated for more than 48 hours
- With a confirmed community-acquired SARS-CoV2 pneumonia
Who cannot join
- Refusal to participate
- Lack of social security coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Ventilator-associated Lower Respiratory Tract Infections Among Patients With SARS-CoV-2 Infection Throughout the First and the Second Wave of the Pandemic: a European Comparative Cohort Study
Multicenter observational retrospective cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients from the first and the second wave of the pandemic.
Read the detailed description
CoVAPid2 is a multicenter retrospective observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients from the first and the second wave of the pandemic. Patients with confirmed SARS-CoV-2 community-acquired pneumonia and receiving invasive mechanical ventilation for more than 48h in the participating ICUs from the start of COVID pandemic are eligible for this study. Consecutive patients will be included from the beginning of the first wave (starting on 01-01-2020, data already collected in the CoVAPid1 study) and the second wave (starting on 10-01-2020). 10-20 patients per wave will be included in each center. VAT and VAP are defined using clinical, radiological and quantitative microbiological criteria.
- Conditions
- Severe COVID-19
- Keywords
- SARS-CoV-2, ventilator-associated tracheobronchitis, ventilator-associated pneumonia, bacterial co-infection, COVID-associated pulmonary aspergillosis
- Medical subject headings
- COVID-19, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 first wave | Patients with confirmed SARS-CoV-2 infection and receiving invasive mechanical ventilation for more than 48h, in the first wave of the pandemic, starting on 01-01-2020 | |
| SARS-CoV-2 second wave | Patients with confirmed SARS-CoV-2 infection and receiving invasive mechanical ventilation for more than 48h, in the second wave of the pandemic, starting on 10-01-2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis)
Measured: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
Secondary outcomes (8)
Cumulative incidence of ventilator-associated tracheobronchitis
Measured: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
Cumulative incidence of ventilator-associated pneumonia
Measured: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
Prevalence of early bacterial coinfection
Measured: from day 0 to day 2 of mechanical ventilation
Cumulative incidence of COVID-associated pulmonary aspergillosis
Measured: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
ICU mortality
Measured: at day 28
Mortality
Measured: at day 28
Duration of mechanical ventilation (number of days under mechanical ventilation)
Measured: from the start of mechanical ventilation to extubation or day 28 after intubation
Duration of ICU stay (number of days in the ICU)
Measured: from the ICU admission to discharge or day 28 after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start15 Nov 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Why it stopped: end of COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad NSEIR, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256511
- Sponsor's protocol ID
- HLJ_2022_01
- Acronym
- CoVAPid2
- Status last verified
- May 2026
- First submitted
- 24 Feb 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Ventilator-associated Lower Respiratory Tract Infections Among Patients With SARS-CoV-2 Infection Throughout the First and the Second Wave of the Pandemic: a European Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT05256511
- Acronym / sponsor ID
- CoVAPid2 / HLJ_2022_01
- Conditions
- Severe COVID-19
- Keywords
- SARS-CoV-2, ventilator-associated tracheobronchitis, ventilator-associated pneumonia, bacterial co-infection, COVID-associated pulmonary aspergillosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: end of COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 25 Feb 2022 (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.
Multicenter observational retrospective cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients from the first and the second wave of the pandemic.
Detailed description
CoVAPid2 is a multicenter retrospective observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients from the first and the second wave of the pandemic. Patients with confirmed SARS-CoV-2 community-acquired pneumonia and receiving invasive mechanical ventilation for more than 48h in the participating ICUs from the start of COVID pandemic are eligible for this study. Consecutive patients will be included from the beginning of the first wave (starting on 01-01-2020, data already collected in the CoVAPid1 study) and the second wave (starting on 10-01-2020). 10-20 patients per wave will be included in each center. VAT and VAP are defined using clinical, radiological and quantitative microbiological criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 first wave | – | –Patients with confirmed SARS-CoV-2 infection and receiving invasive mechanical ventilation for more than 48h, in the first wave of the pandemic, starting on 01-01-2020 |
| SARS-CoV-2 second wave | – | –Patients with confirmed SARS-CoV-2 infection and receiving invasive mechanical ventilation for more than 48h, in the second wave of the pandemic, starting on 10-01-2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed SARS-CoV-2 community-acquired pneumonia and receiving invasive mechanical ventilation for more than 48h in the participating ICUs from the start of COVID pandemic are eligible for this study.
Key inclusion criteria (4 listed)
- Major (18 years and older)
- Admitted to the ICU
- Intubated and mechanically ventilated for more than 48 hours
- With a confirmed community-acquired SARS-CoV2 pneumonia
Key exclusion criteria (2 listed)
- Refusal to participate
- Lack of social security coverage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis)
Time frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
8 secondary outcomes
Cumulative incidence of ventilator-associated tracheobronchitis
Time frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
Cumulative incidence of ventilator-associated pneumonia
Time frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
Prevalence of early bacterial coinfection
Time frame: from day 0 to day 2 of mechanical ventilation
Cumulative incidence of COVID-associated pulmonary aspergillosis
Time frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
ICU mortality
Time frame: at day 28
Mortality
Time frame: at day 28
Duration of mechanical ventilation (number of days under mechanical ventilation)
Time frame: from the start of mechanical ventilation to extubation or day 28 after intubation
Duration of ICU stay (number of days in the ICU)
Time frame: from the ICU admission to discharge or day 28 after admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Saad NSEIR, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe COVID-19, run by University Hospital, Lille at 1 site in France.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 22 May 2026. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis) (time frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.