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

Completed

• Conditions: Dyspnea; Covid19

• Registration Number: NCT04505631
• Lead Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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.

Study Timeline

• Study Start: 2020-06-10
• Status Verified: 2020-08
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-10
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of respiratory sequelae	6 months after hospital discharge	The presence of respiratory sequelae will be assessed by low dose thoracic tomodensitometry

Secondary Outcome Measures

Name	Time	Method
RV/TLC ratio (%)	3 months after hospital discharge	Respiratory functional exploration
Arterial oxygen partial pressure (PaO2, mmHg)	3 months after hospital discharge	Arterial gasometry will be performed under ambient air and under oxygen
Forced vital capacity (FVC, %)	3 months after hospital discharge	Respiratory functional exploration
Forced expiratory volume in 1 second (FEV1, %)	3 months after hospital discharge	Respiratory functional exploration
Tiffeneau-Pinelli index (FEV1/FVC, %)	3 months after hospital discharge	Respiratory functional exploration
Diffusion capacity of the lungs for carbon monoxide (DLCO, %)	3 months after hospital discharge	Respiratory functional exploration
pH	3 months after hospital discharge	Arterial gasometry will be performed under ambient air and under oxygen
Bicarbonate concentration (mmol/L)	3 months after hospital discharge	Arterial gasometry will be performed under ambient air and under oxygen
Six-minute walk test	3 months after hospital discharge	Six-minute walk test will be performed under ambient air and under oxygen
Presence of respiratory sequelae on low dose thoracic tomodensitometry	3 months after hospital discharge
Total lung capacity (TLC, %)	3 months after hospital discharge	Respiratory functional exploration
Maximal expiratory pressure (MEP, %)	3 months after hospital discharge	Respiratory functional exploration
Arterial oxygen saturation (SaO2, %)	3 months after hospital discharge	Arterial gasometry will be performed under ambient air and under oxygen
Residual volume (RV, %)	3 months after hospital discharge	Respiratory functional exploration
Maximal inspiratory pressure (MIP, %)	3 months after hospital discharge	Respiratory functional exploration
Arterial carbon dioxide partial pressure (PaCO2, mmHg)	3 months after hospital discharge	Arterial gasometry will be performed under ambient air and under oxygen

Trial Locations

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

Centre Hospitalier Colmar; 🇫🇷 Colmar, France

Centre Hospitalier Douai; 🇫🇷 Douai, France

Centre Hospitalier du Mans; 🇫🇷 Le Mans, France

Centre Hospitalier de Dunkerque; 🇫🇷 Dunkerque, France

Centre Hospitalier Départemental Vendée - La Roche sur Yon; 🇫🇷 La Roche-sur-Yon, France

Centre Hospitalier Robert Boulin - Libourne; 🇫🇷 Libourne, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Metz-Tessy, France

Centre Hospitalier Régional Metz-Thioville; 🇫🇷 Metz, France

Centre Hospitalier Le Raincy Montfermeil; 🇫🇷 Montfermeil, France

Centre Hospitalier Régional Orléans; 🇫🇷 Orléans, France

Centre Hospitalier de Soissons; 🇫🇷 Soissons, France