Follow-up of Respiratory Sequelae of Hospitalized Patients With COVID-19
NCT ID: NCT04505631
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
332 participants
OBSERVATIONAL
2020-06-10
2021-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
OTHER
Responsible Party
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Principal Investigators
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George-Daniel Calcaianu, MD
Role: PRINCIPAL_INVESTIGATOR
GHRMSA hospital
Locations
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Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace
Mulhouse, Alsace, France
Centre Hospitalier de la Côte Basque - Bayonne
Bayonne, , France
Centre Hospitalier Métropole Savoie
Chambéry, , France
Centre Hospitalier Colmar
Colmar, , France
Centre Hospitalier Douai
Douai, , France
Centre Hospitalier de Dunkerque
Dunkirk, , France
Centre Hospitalier Départemental Vendée - La Roche sur Yon
La Roche-sur-Yon, , France
Centre Hospitalier du Mans
Le Mans, , France
Centre Hospitalier Robert Boulin - Libourne
Libourne, , France
Centre Hospitalier Régional Metz-Thioville
Metz, , France
Centre Hospitalier Annecy Genevois
Metz-Tessy, , France
Centre Hospitalier Le Raincy Montfermeil
Montfermeil, , France
Centre Hospitalier Régional Orléans
Orléans, , France
Centre Hospitalier de Soissons
Soissons, , France
Countries
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Other Identifiers
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IDRCB 2020-A01089-30
Identifier Type: OTHER
Identifier Source: secondary_id
GHR 1052
Identifier Type: -
Identifier Source: org_study_id