Medium and Long Term Follow-up of COVID-19 Infected Patients: Research and Characterization of Pulmonary Sequelae (COV-RECUP)

Centre Hospitalier Universitaire de Besancon

Status

Active, not recruiting

Conditions

Sars-CoV2

Treatments

Diagnostic Test: Pulmonary function testing

Study type

Interventional

Funder types

Other

Identifiers

NCT04519320

2020/499

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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".