Clinical trial NCT04505631: Follow-up of Respiratory Sequelae of Hospitalized Patients With COVID-19
Official title: Follow-up of Respiratory Sequelae of Patients Hospitalized With SARS-CoV-2: a Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Dyspnea
Keywords: COVID19
PNEUMOPATHY
DYSPNEA
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been hospitalized for severe pneumonia due to SARS-CoV-2 infection will be seen in consultation at approximately 3 and 6 months after hospital discharge, as per standard practice.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of respiratory sequelae
timeFrame: 6 months after hospital discharge
Secondary outcomes:
measure: Presence of respiratory sequelae on low dose thoracic tomodensitometry
timeFrame: 3 months after hospital discharge
measure: Forced vital capacity (FVC, %)
timeFrame: 6 months after hospital discharge
measure: Forced vital capacity (FVC, %)
timeFrame: 3 months after hospital discharge
measure: Forced expiratory volume in 1 second (FEV1, %)
timeFrame: 6 months after hospital discharge
measure: Forced expiratory volume in 1 second (FEV1, %)
timeFrame: 3 months after hospital discharge
measure: Tiffeneau-Pinelli index (FEV1/FVC, %)
timeFrame: 6 months after hospital discharge
measure: Tiffeneau-Pinelli index (FEV1/FVC, %)
timeFrame: 3 months after hospital discharge
measure: Total lung capacity (TLC, %)
timeFrame: 6 months after hospital discharge
measure: Total lung capacity (TLC, %)
timeFrame: 3 months after hospital discharge
measure: Residual volume (RV, %)
timeFrame: 6 months after hospital discharge
measure: Residual volume (RV, %)
timeFrame: 3 months after hospital discharge
measure: RV/TLC ratio (%)
timeFrame: 6 months after hospital discharge
measure: RV/TLC ratio (%)
timeFrame: 3 months after hospital discharge
measure: Maximal inspiratory pressure (MIP, %)
timeFrame: 6 months after hospital discharge
measure: Maximal inspiratory pressure (MIP, %)
timeFrame: 3 months after hospital discharge
measure: Maximal expiratory pressure (MEP, %)
timeFrame: 6 months after hospital discharge
measure: Maximal expiratory pressure (MEP, %)
timeFrame: 3 months after hospital discharge
measure: Diffusion capacity of the lungs for carbon monoxide (DLCO, %)
timeFrame: 6 months after hospital discharge
measure: Diffusion capacity of the lungs for carbon monoxide (DLCO, %)
timeFrame: 3 months after hospital discharge
measure: pH
timeFrame: 6 months after hospital discharge
measure: pH
timeFrame: 3 months after hospital discharge
measure: Arterial oxygen partial pressure (PaO2, mmHg)
timeFrame: 6 months after hospital discharge
measure: Arterial oxygen partial pressure (PaO2, mmHg)
timeFrame: 3 months after hospital discharge
measure: Arterial carbon dioxide partial pressure (PaCO2, mmHg)
timeFrame: 6 months after hospital discharge
measure: Arterial carbon dioxide partial pressure (PaCO2, mmHg)
timeFrame: 3 months after hospital discharge
measure: Bicarbonate concentration (mmol/L)
timeFrame: 6 months after hospital discharge
measure: Bicarbonate concentration (mmol/L)
timeFrame: 3 months after hospital discharge
measure: Arterial oxygen saturation (SaO2, %)
timeFrame: 6 months after hospital discharge
measure: Arterial oxygen saturation (SaO2, %)
timeFrame: 3 months after hospital discharge
measure: Six-minute walk test
timeFrame: 6 months after hospital discharge
measure: Six-minute walk test
timeFrame: 3 months after hospital discharge
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace
state: Alsace
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque - Bayonne
city: Chambéry
country: France
facility: Centre Hospitalier Métropole Savoie
city: Colmar
country: France
facility: Centre Hospitalier Colmar
city: Douai
country: France
facility: Centre Hospitalier Douai
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée - La Roche sur Yon
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Libourne
country: France
facility: Centre Hospitalier Robert Boulin - Libourne
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Metz
country: France
facility: Centre Hospitalier Régional Metz-Thioville
city: Montfermeil
country: France
facility: Centre Hospitalier Le Raincy Montfermeil
city: Orléans
country: France
facility: Centre Hospitalier Régional Orléans
city: Soissons
country: France
facility: Centre Hospitalier de Soissons
Study officials:
affiliation: GHRMSA hospital
name: George-Daniel Calcaianu, MD
role: PRINCIPAL_INVESTIGATOR
References: