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

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace332 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

332

Conditions

Covid19 Dyspnea

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * 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

Locations (14)

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

Outcomes

Primary Outcomes

Presence of respiratory sequelae

The presence of respiratory sequelae will be assessed by low dose thoracic tomodensitometry

Time frame: 6 months after hospital discharge

Secondary Outcomes

Presence of respiratory sequelae on low dose thoracic tomodensitometry

Time frame: 3 months after hospital discharge

Forced vital capacity (FVC, %)

Respiratory functional exploration

Time frame: 6 months after hospital discharge

Forced vital capacity (FVC, %)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

Forced expiratory volume in 1 second (FEV1, %)

Respiratory functional exploration

Time frame: 6 months after hospital discharge

Forced expiratory volume in 1 second (FEV1, %)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

Tiffeneau-Pinelli index (FEV1/FVC, %)

Respiratory functional exploration

Time frame: 6 months after hospital discharge

Tiffeneau-Pinelli index (FEV1/FVC, %)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

Total lung capacity (TLC, %)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 4 more locations

Respiratory functional exploration

Time frame: 6 months after hospital discharge

Total lung capacity (TLC, %)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

Residual volume (RV, %)

Respiratory functional exploration

Time frame: 6 months after hospital discharge

Residual volume (RV, %)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

RV/TLC ratio (%)

Respiratory functional exploration

Time frame: 6 months after hospital discharge

RV/TLC ratio (%)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

Maximal inspiratory pressure (MIP, %)

Respiratory functional exploration

Time frame: 6 months after hospital discharge

Maximal inspiratory pressure (MIP, %)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

Maximal expiratory pressure (MEP, %)

Respiratory functional exploration

Time frame: 6 months after hospital discharge

Maximal expiratory pressure (MEP, %)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

Diffusion capacity of the lungs for carbon monoxide (DLCO, %)

Respiratory functional exploration

Time frame: 6 months after hospital discharge

Diffusion capacity of the lungs for carbon monoxide (DLCO, %)

Respiratory functional exploration

Time frame: 3 months after hospital discharge

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 6 months after hospital discharge

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 3 months after hospital discharge

Arterial oxygen partial pressure (PaO2, mmHg)

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 6 months after hospital discharge

Arterial oxygen partial pressure (PaO2, mmHg)

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 3 months after hospital discharge

Arterial carbon dioxide partial pressure (PaCO2, mmHg)

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 6 months after hospital discharge

Arterial carbon dioxide partial pressure (PaCO2, mmHg)

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 3 months after hospital discharge

Bicarbonate concentration (mmol/L)

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 6 months after hospital discharge

Bicarbonate concentration (mmol/L)

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 3 months after hospital discharge

Arterial oxygen saturation (SaO2, %)

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 6 months after hospital discharge

Arterial oxygen saturation (SaO2, %)

Arterial gasometry will be performed under ambient air and under oxygen

Time frame: 3 months after hospital discharge

Six-minute walk test

Six-minute walk test will be performed under ambient air and under oxygen

Time frame: 6 months after hospital discharge

Six-minute walk test

Six-minute walk test will be performed under ambient air and under oxygen

Time frame: 3 months after hospital discharge