Evolution of Respiratory Function in Lung Transplant Patients With Moderate to Severe Covid-19 Infection (Cov- EvoLuT)

July 4, 2024 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Anesthésie Réanimation - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Charles Ambroise TACQUARD, MD
        • Sub-Investigator:
          • Déborah DESSOLIN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subject having expressed his opposition to the reuse of his data for scientific research purposes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Files analyzed retrospectively cover the period from March 1, 2020 to December 31, 2022.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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