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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, Dyspnea

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of respiratory sequelae | The presence of respiratory sequelae will be assessed by low dose thoracic tomodensitometry | 6 months after hospital discharge | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID19, PNEUMOPATHY, DYSPNEA