Sars-CoV2
Conditions
Brief summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of atypical emerging pneumonia. The clinical spectrum varies from an asymptomatic or mild illness to a serious illness with a high risk of mortality. The most severely affected patients (5%) present an acute respiratory distress syndrome (ARDS), requiring assistance with mechanical ventilation in intensive care. In 2003, persistent lung damage was observed in a third of patients in a Singaporean cohort one year after SARS-CoV infection. A Chinese study showed that 27.3% of their SARS-CoV patients presented a decreased carbon monoxide diffusion (DLCO) and 21.5% of pulmonary fibrosis lesions. Due to the very recent emergence of SARS-CoV-2, no data is currently available of long-term outcome of these patients. However, recent publications including short-term CT monitoring suggest the genesis of fibrotic pulmonary parenchymal sequelae. In view of these data, the investigators can fear the occurrence of pulmonary sequelae in patients infected with SARS-CoV-2. It is therefore essential to evaluate the evolution of the respiratory status of the most severe patients who have had a stay in intensive care with respiratory assistance.
Interventions
DIAGNOSTIC_TESTPulmonary function testing
D0: date of first symptoms of SARS-COV-2 M3: D0 + 3 months * Blood test * Blood gases * Clinical examination * CT Scan * Pulmonary function testing (PFT) * 6-minute walk test (6MWT) * MOS SF-36 Questionnaire * HADS scale * Ventilatory polygraphy M6: D0 + 6 months * Clinical examination * PFT * 6MWT * MOS SF-36 Questionnaire * HADS scale M12: D0 + 12 months * Blood test * Blood gases * Clinical examination * CT Scan (If anomaly found at M3) * PFT * Pulmonary Exercise Stress Test * 6MWT * MOS SF-36 Questionnaire * HADS scale Subsequent follow-up will be performed only in patients with an alteration defined by a DLCO \<LLN and / or an abnormality objectified at CT-Scan attributable to SARS-CoV-2. M24, M36, M48 and M60: D0 + 24, 36, 48, 60 months * Clinical examination * PFT * 6MWT * MOS SF-36 Questionnaire * HADS scale
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patient infected by SARS-CoV-2 (diagnosed by RT-PCR and / or typical CT imaging) * Patient hospitalized in the intensive care units of Besançon or Dijon hospitals for severe SARS-CoV-2 pneumonia * Postmenopausal woman for at least 24 months or surgically sterilized, or, for woman of childbearing age, use of an effective method of contraception * Signature of informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study. * Affiliation to a French social security system .
Exclusion criteria
* Chronic respiratory failure under long-term oxygen therapy * Known diffuse invasive pneumonia * Life expectancy estimated at less than one year by the doctor * Legal incapacity or limited legal capacity * History of psychiatric illness, intellectual disability, lack of motivation or other conditions that may limit the understanding of informed consent * Subject unlikely to cooperate in the study and / or weak cooperation anticipated by the investigator * Subject without health insurance * Pregnant and / or lactating woman * Subject being in the exclusion period of another study or foreseen by the national file of the volunteers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients with an alteration of the capillary alveolus barrier at 12 months of follow-up, characterized by a decreased of the diffusing capacity for carbon monoxide (DLCO) below the lower limit of normal | 12 months after the first symptoms of SARS-COV-2 | DLCO |
Countries
France
Outcome results
None listed