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

Severe SARS-CoV2 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376840
• Other study ID #: PO20066
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2020
• Est. completion date: October 28, 2022

Study information

• Verified date: November 2020
• Source: CHU de Reims
• Contact: Jeanne-Marie PEROTIN-COLLARD
• Phone: 03 10 73 67 63
• Email: jmperotin-collard[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: October 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Severe SARS-CoV2 Pneumonia

Intervention

Other:
• Blood sample and data record
Blood sample and data record

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	medium-term respiratory complications	Interstitial lung disease diagnosed with a thoracic CT-scan	3 months
Secondary	long-term respiratory complications	Interstitial lung disease diagnosed with a thoracic CT-scan	12 months