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

Sars-CoV2 Clinical Trial

— COV-RECUP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04519320
• Other study ID #: 2020/499
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: August 18, 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: August 18, 2025
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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".

Related Conditions & MeSH terms

• Sars-CoV2

Intervention

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 <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

Locations

Country	Name	City	State
France	CHU Besançon	Besançon	Franche-Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	DLCO	12 months after the first symptoms of SARS-COV-2