Covid19, Dyspnea
Conditions
Keywords
COVID19, PNEUMOPATHY, DYSPNEA
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.
Interventions
None listed
Sponsors
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of respiratory sequelae | 6 months after hospital discharge | The presence of respiratory sequelae will be assessed by low dose thoracic tomodensitometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of respiratory sequelae on low dose thoracic tomodensitometry | 3 months after hospital discharge | — |
| Forced vital capacity (FVC, %) | 6 months after hospital discharge | Respiratory functional exploration |
| Forced expiratory volume in 1 second (FEV1, %) | 6 months after hospital discharge | Respiratory functional exploration |
| Tiffeneau-Pinelli index (FEV1/FVC, %) | 6 months after hospital discharge | Respiratory functional exploration |
| Residual volume (RV, %) | 6 months after hospital discharge | Respiratory functional exploration |
| RV/TLC ratio (%) | 6 months after hospital discharge | Respiratory functional exploration |
| Maximal inspiratory pressure (MIP, %) | 6 months after hospital discharge | Respiratory functional exploration |
| Total lung capacity (TLC, %) | 6 months after hospital discharge | Respiratory functional exploration |
| Diffusion capacity of the lungs for carbon monoxide (DLCO, %) | 6 months after hospital discharge | Respiratory functional exploration |
| pH | 6 months after hospital discharge | Arterial gasometry will be performed under ambient air and under oxygen |
| Arterial oxygen partial pressure (PaO2, mmHg) | 6 months after hospital discharge | Arterial gasometry will be performed under ambient air and under oxygen |
| Arterial carbon dioxide partial pressure (PaCO2, mmHg) | 6 months after hospital discharge | Arterial gasometry will be performed under ambient air and under oxygen |
| Arterial oxygen saturation (SaO2, %) | 6 months after hospital discharge | Arterial gasometry will be performed under ambient air and under oxygen |
| Bicarbonate concentration (mmol/L) | 6 months after hospital discharge | Arterial gasometry will be performed under ambient air and under oxygen |
| Six-minute walk test | 6 months after hospital discharge | Six-minute walk test will be performed under ambient air and under oxygen |
| Maximal expiratory pressure (MEP, %) | 6 months after hospital discharge | Respiratory functional exploration |
Countries
France
Outcome results
None listed