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NCT04505631 Clinical Trial

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

Covid19 Clinical Trial

— SISCOVID  

Official title:
Follow-up of Respiratory Sequelae of Patients Hospitalized With SARS-CoV-2: a Prospective Multicenter Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04505631
Other study ID # GHR 1052
Secondary ID IDRCB 2020-A0108
Status Completed
Phase
First received
Last updated
Start date June 10, 2020
Est. completion date January 15, 2021

Study information
Verified date August 2020
Source Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 332
Est. completion date January 15, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
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 Dunkerque
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 Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace Mulhouse Alsace
France Centre Hospitalier Régional Orléans Orléans
France Centre Hospitalier de Soissons Soissons

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of respiratory sequelae The presence of respiratory sequelae will be assessed by low dose thoracic tomodensitometry 6 months after hospital discharge
Secondary Presence of respiratory sequelae on low dose thoracic tomodensitometry 3 months after hospital discharge
Secondary Forced vital capacity (FVC, %) Respiratory functional exploration 6 months after hospital discharge
Secondary Forced vital capacity (FVC, %) Respiratory functional exploration 3 months after hospital discharge
Secondary Forced expiratory volume in 1 second (FEV1, %) Respiratory functional exploration 6 months after hospital discharge
Secondary Forced expiratory volume in 1 second (FEV1, %) Respiratory functional exploration 3 months after hospital discharge
Secondary Tiffeneau-Pinelli index (FEV1/FVC, %) Respiratory functional exploration 6 months after hospital discharge
Secondary Tiffeneau-Pinelli index (FEV1/FVC, %) Respiratory functional exploration 3 months after hospital discharge
Secondary Total lung capacity (TLC, %) Respiratory functional exploration 6 months after hospital discharge
Secondary Total lung capacity (TLC, %) Respiratory functional exploration 3 months after hospital discharge
Secondary Residual volume (RV, %) Respiratory functional exploration 6 months after hospital discharge
Secondary Residual volume (RV, %) Respiratory functional exploration 3 months after hospital discharge
Secondary RV/TLC ratio (%) Respiratory functional exploration 6 months after hospital discharge
Secondary RV/TLC ratio (%) Respiratory functional exploration 3 months after hospital discharge
Secondary Maximal inspiratory pressure (MIP, %) Respiratory functional exploration 6 months after hospital discharge
Secondary Maximal inspiratory pressure (MIP, %) Respiratory functional exploration 3 months after hospital discharge
Secondary Maximal expiratory pressure (MEP, %) Respiratory functional exploration 6 months after hospital discharge
Secondary Maximal expiratory pressure (MEP, %) Respiratory functional exploration 3 months after hospital discharge
Secondary Diffusion capacity of the lungs for carbon monoxide (DLCO, %) Respiratory functional exploration 6 months after hospital discharge
Secondary Diffusion capacity of the lungs for carbon monoxide (DLCO, %) Respiratory functional exploration 3 months after hospital discharge
Secondary pH Arterial gasometry will be performed under ambient air and under oxygen 6 months after hospital discharge
Secondary pH Arterial gasometry will be performed under ambient air and under oxygen 3 months after hospital discharge
Secondary Arterial oxygen partial pressure (PaO2, mmHg) Arterial gasometry will be performed under ambient air and under oxygen 6 months after hospital discharge
Secondary Arterial oxygen partial pressure (PaO2, mmHg) Arterial gasometry will be performed under ambient air and under oxygen 3 months after hospital discharge
Secondary Arterial carbon dioxide partial pressure (PaCO2, mmHg) Arterial gasometry will be performed under ambient air and under oxygen 6 months after hospital discharge
Secondary Arterial carbon dioxide partial pressure (PaCO2, mmHg) Arterial gasometry will be performed under ambient air and under oxygen 3 months after hospital discharge
Secondary Bicarbonate concentration (mmol/L) Arterial gasometry will be performed under ambient air and under oxygen 6 months after hospital discharge
Secondary Bicarbonate concentration (mmol/L) Arterial gasometry will be performed under ambient air and under oxygen 3 months after hospital discharge
Secondary Arterial oxygen saturation (SaO2, %) Arterial gasometry will be performed under ambient air and under oxygen 6 months after hospital discharge
Secondary Arterial oxygen saturation (SaO2, %) Arterial gasometry will be performed under ambient air and under oxygen 3 months after hospital discharge
Secondary Six-minute walk test Six-minute walk test will be performed under ambient air and under oxygen 6 months after hospital discharge
Secondary Six-minute walk test Six-minute walk test will be performed under ambient air and under oxygen 3 months after hospital discharge
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