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
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Dyspnea

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