Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia - COVID-19

Not Applicable

• Conditions: Severe SARS-CoV2 Pneumonia
• Interventions: Other: Blood sample and data record

• Registration Number: NCT04376840
• Lead Sponsor: CHU de Reims

Brief Summary

Studies performed after coronavirus epidemics (severe acute respiratory syndrome coronavirus, SARS-CoV and Middle East respiratory syndrome coronavirus, MERS-CoV) have shown a long-term impact on respiratory morbidity, musculoskeletal and psycho-social repercussions.

Patients with SARS-CoV pneumonia had fibrotic pulmonary sequelae at 45 days (lower DLCO in 27.3% of cases and radiological lesions in 21.5% of cases). In the MERS-CoV pneumonia study, patients had radiological sequelae in 33% of cases and the 12-month evaluation showed persistence of radiological abnormalities in 23.7% of the cases despite an improvement in respiratory function.

Clinical presentation and therapeutic management of severe SARS-CoV-2 infection are in part similar to those induced by SARS-CoV and MERS-CoV. Long-term respiratory complications are therefore expected.

Detailed Description

Objective is to evaluate prevalence of long-term respiratory complications after severe SARS-CoV2 pneumonia.

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-06
• Study Start: 2020-05-28
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30
• Primary Completion: 2022-01-28
• Study Completion: 2022-10-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Adult patient
• Patient with with severe SARS-CoV2 pneumonia
• Patient consenting to participate to the study
• Patient enrolled in the national healthcare insurance program

Exclusion Criteria

• Patient under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adults with severe SARS-CoV2 pneumonia	Blood sample and data record	adult with severe SARS-CoV2 pneumonia

Primary Outcome Measures

Name	Time	Method
medium-term respiratory complications	3 months	Interstitial lung disease diagnosed with a thoracic CT-scan

Secondary Outcome Measures

Name	Time	Method
long-term respiratory complications	12 months	Interstitial lung disease diagnosed with a thoracic CT-scan

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France