COVID-19 Respiratory InfectionCov- EvoLuTNCT06490744
Evolution of Respiratory Function in Lung Transplant Patients With Moderate to Severe Covid-19 Infection
An observational study of COVID-19 Respiratory Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The SARS-Cov-2 infection pandemic has caused a large number of acute respiratory failures and deaths across the world. Certain factors have been identified as associated with a higher risk of developing a severe form and dying. Immunosuppression has been identified as a risk factor for progressing to a severe form. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Respiratory Infection
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2023to 31 Dec 2024
- 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: Adult lung transplant patients who had a Covid-19 infection and were treated at the Strasbourg University Hospital during the period from March 1, 2020 to December 31, 2022.
Who may be able to join
- Adult patient
- Lung transplant patient (monopulmonary or bipulmonary)
- Covid diagnosed by RT-PCR between March 1, 2020 and December 31, 2022
- Hospitalization at the University Hospitals of Strasbourg for COVID-19
- Patient followed in the context of their lung transplant at the University Hospitals of Strasbourg
- Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie Réanimation - CHU de Strasbourg - France
Strasbourg, 67091
Charles Ambroise TACQUARD, MD, 33 3 69 55 16 08, charlesambroise.tacquard@chru-strasbourg.fr
Charles Ambroise TACQUARD, MD
About this study
Official title: Evolution of Respiratory Function in Lung Transplant Patients With Moderate to Severe SARS-Cov-2 Infection, Single-center Retrospective Study
The SARS-Cov-2 infection pandemic has caused a large number of acute respiratory failures and deaths across the world. Certain factors have been identified as associated with a higher risk of developing a severe form and dying. Immunosuppression has been identified as a risk factor for progressing to a severe form.
Lung transplant patients were particularly vulnerable during this period, with a high frequency of respiratory compromise, sometimes progressing towards acute respiratory distress syndrome and, at a later stage, towards fibrotic forms. The impact of the infection on the immunological status of the patient and on the tolerance of the transplant have been little studied. The various treatments implemented during the pandemic have rapidly evolved (immunotherapy, vaccination, convalescent plasma transfusion, etc.) which may have modulated this risk. The evolution of respiratory function may be linked to the respiratory infection itself, or to the severity of respiratory damage during the infection. It is therefore relevant to compare patients with a moderate form of COVID-19 (non-intubated patients) to patients with severe forms, requiring invasive ventilation in intensive care. The evolution of respiratory function after infection has not yet been studied.
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- Covid-19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, SARS-Cov-2
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the evolution of respiratory function in lung transplant recipients after moderate to severe Covid-19.
This retrospective study concerns lung transplant patients who had a Covid-19 infection and were treated at the Strasbourg University Hospital during the period from March 1, 2020 to December 31, 2022.
Measured: Files analyzed retrospectively cover the period from March 1, 2020 to December 31, 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start4 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490744
- Sponsor's protocol ID
- 9058
- Acronym
- Cov- EvoLuT
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Respiratory Function in Lung Transplant Patients With Moderate to Severe SARS-Cov-2 Infection, Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06490744
- Acronym / sponsor ID
- Cov- EvoLuT / 9058
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- Covid-19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, SARS-Cov-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jul 2024 (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.
The SARS-Cov-2 infection pandemic has caused a large number of acute respiratory failures and deaths across the world. Certain factors have been identified as associated with a higher risk of developing a severe form and dying. Immunosuppression has been identified as a risk factor for progressing to a severe form.
Lung transplant patients were particularly vulnerable during this period, with a high frequency of respiratory compromise, sometimes progressing towards acute respiratory distress syndrome and, at a later stage, towards fibrotic forms. The impact of the infection on the immunological status of the patient and on the tolerance of the transplant have been little studied. The various treatments implemented during the pandemic have rapidly evolved (immunotherapy, vaccination, convalescent plasma transfusion, etc.) which may have modulated this risk. The evolution of respiratory function may be linked to the respiratory infection itself, or to the severity of respiratory damage during the infection. It is therefore relevant to compare patients with a moderate form of COVID-19 (non-intubated patients) to patients with severe forms, requiring invasive ventilation in intensive care. The evolution of respiratory function after infection has not yet been studied.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult lung transplant patients who had a Covid-19 infection and were treated at the Strasbourg University Hospital during the period from March 1, 2020 to December 31, 2022.
Key inclusion criteria (6 listed)
- Adult patient
- Lung transplant patient (monopulmonary or bipulmonary)
- Covid diagnosed by RT-PCR between March 1, 2020 and December 31, 2022
- Hospitalization at the University Hospitals of Strasbourg for COVID-19
- Patient followed in the context of their lung transplant at the University Hospitals of Strasbourg
Key exclusion criteria (1 listed)
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
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
Retrospective description of the evolution of respiratory function in lung transplant recipients after moderate to severe Covid-19.
Time frame: Files analyzed retrospectively cover the period from March 1, 2020 to December 31, 2022.
This retrospective study concerns lung transplant patients who had a Covid-19 infection and were treated at the Strasbourg University Hospital during the period from March 1, 2020 to December 31, 2022.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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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.
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 COVID-19 Respiratory Infection, run by University Hospital, Strasbourg, France 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Ambroise TACQUARD, MD (33 3 69 55 16 08, charlesambroise.tacquard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the evolution of respiratory function in lung transplant recipients after moderate to severe Covid-19. (time frame: Files analyzed retrospectively cover the period from March 1, 2020 to December 31, 2022.). 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 8 Jul 2024.