Official Title
Medium and Long Term Follow-up of SARS-COV-2 Infected Patients Treated at Besançon and Dijon Hospitals: Research and Characterization of Pulmonary Sequelae
Brief Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of atypicalemerging pneumonia. The clinical spectrum varies from an asymptomatic or mild illness toa serious illness with a high risk of mortality. The most severely affected patients (5%)present an acute respiratory distress syndrome (ARDS), requiring assistance withmechanical ventilation in intensive care.In 2003, persistent lung damage was observed in a third of patients in a Singaporeancohort one year after SARS-CoV infection. A Chinese study showed that 27.3% of theirSARS-CoV patients presented a decreased carbon monoxide diffusion (DLCO) and 21.5% ofpulmonary fibrosis lesions.Due to the very recent emergence of SARS-CoV-2, no data is currently available oflong-term outcome of these patients. However, recent publications including short-term CTmonitoring suggest the genesis of fibrotic pulmonary parenchymal sequelae.In view of these data, the investigators can fear the occurrence of pulmonary sequelae inpatients infected with SARS-CoV-2. It is therefore essential to evaluate the evolution ofthe respiratory status of the most severe patients who have had a stay in intensive carewith respiratory assistance.

Active, not recruiting
SARS-COV2

Diagnostic Test: Pulmonary 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

M24, M36, M48 and M60: D0 + 24, 36, 48, 60 months

- Clinical examination

- PFT

- 6MWT

- MOS SF-36 Questionnaire

- HADS scale
Other Name: CT Scan,Six minute walk test,Pulmonary Exercise Stress Test,Blood gases,Ventilatory polygraphy,Questionnaires: HADS and MOS SF-36,Blood Test

Eligibility Criteria

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".

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 79 Years
Countries
France
Locations

CHU Besançon
Besançon, Franche-Comté, France

Centre Hospitalier Universitaire de Besancon
NCT Number