Follow-up of Respiratory Sequelae of Hospitalized Patients With COVID-19

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    100
  • sponsor
    Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Updated on 24 January 2021
pneumonia
SARS
chest ct

Summary

The objective of this multicenter observational study is to describe respiratory sequelae of COVID-19 patients hospitalized for severe pneumonia requiring oxygen supply.

Description

Main objective To assess respiratory sequelae after SARS-CoV-2 infection in hospitalized patients with severe pneumonia requiring oxygen supply and followed up for 6 months after hospital discharge (see primary and secondary outcomes).

Secondary objectives

To describe pulmonary sequelae according to :

  • the unit in which the patient was hospitalized,
  • the maximum oxygen flow rate required during hospitalization,
  • McCabe score,
  • age,
  • tobacco consumption,
  • biological data (e.g. blood count, CRP, fibrinogen, LDH, albumin, D-dimer, ferritin),
  • number of days from onset of symptoms to hospitalization,
  • co-morbidities (e.g. diabetes, hypertension, coronary artery disease/heart failure, mild to moderate COPD/respiratory failure, overweight),
  • concomitant treatments (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, ACE inhibitors)
  • specific drug treatments administered to treat COVID-19 infection,
  • non-drug treatments (invasive ventilation, non-invasive ventilation, postural treatment) to manage respiratory disorders of COVID-19 infection.

To assess the impact of factors of social inequality on the severity of COVID-19 infection.

Conduct of research Patients who have been hospitalized for severe pneumonia due to CoV-2 SARS infection will be seen in consultation at approximately 3 and 6 months after hospital discharge, as per standard practice.

Details
Condition Dyspnea, COVID19, breathlessness, shortness of breath, breathing difficulty, difficulty breathing, breathless, trouble breathing, respiratory difficulties, breathing difficulties
Clinical Study IdentifierNCT04505631
SponsorGroupe Hospitalier de la Region de Mulhouse et Sud Alsace
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Dyspnea or COVID19?
Do you have any of these conditions: trouble breathing or breathing difficulty or COVID19 or breathless or Dyspnea or breathlessness or breathing difficulties or difficulty breathing or r...?
Age 18 years old
SARS-CoV-2 infection proven by RT-PCR and/or retrospective serology and/or a COVID-19 syndrome with evocative chest CT scan
Hospitalized for severe pneumonia due to SARS-CoV-2 infection requiring oxygen supply

Exclusion Criteria

Not hospitalized for a severe COVID-19 infection
Absence of respiratory symptoms at V1 (3 months after hospital discharge), defined as: absence of residual exertional dyspnea and persistent pulmonary infiltrates on follow-up chest radiography at 1 month (if available), transcutaneous oxyhemoglobin saturation >94% and normal pulmonary auscultation
Patient with pre-existing chronic lung disease prior to the first episode of COVID-19: chronic obstructive pulmonary disease confirmed by respiratory function testing with a forced expiratory volume in one second (FEV1) < 50% and/or a diffusing capacity for carbon monoxide (DLCO) < 60%, fibrotic lung disease or chronic respiratory failure (on long-term oxygen therapy)
Opposition to participation in the study
Patient under legal protection
Patient not affiliated to/beneficiary of a social security scheme
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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