Medium and Long Term Follow-up of COVID-19 Infected Patients: Research and Characterization of Pulmonary Sequelae
- Conditions
- Sars-CoV2
- Interventions
- Diagnostic Test: Pulmonary function testing
- Registration Number
- NCT04519320
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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 .
- 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".
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SARS-COV 2 Patients Pulmonary function testing -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU Besançon
🇫🇷Besançon, Franche-Comté, France