Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia - COVID-19
Primary Purpose
Severe SARS-CoV2 Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample and data record
Sponsored by
About this trial
This is an interventional diagnostic trial for Severe SARS-CoV2 Pneumonia focused on measuring SARS-CoV2, long term, complication, pneumonia
Eligibility Criteria
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
Sites / Locations
- Damien JOLLYRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adults with severe SARS-CoV2 pneumonia
Arm Description
adult with severe SARS-CoV2 pneumonia
Outcomes
Primary Outcome Measures
medium-term respiratory complications
Interstitial lung disease diagnosed with a thoracic CT-scan
Secondary Outcome Measures
long-term respiratory complications
Interstitial lung disease diagnosed with a thoracic CT-scan
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04376840
Brief Title
Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia - COVID-19
Official Title
Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
January 28, 2022 (Anticipated)
Study Completion Date
October 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe SARS-CoV2 Pneumonia
Keywords
SARS-CoV2, long term, complication, pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adults with severe SARS-CoV2 pneumonia
Arm Type
Experimental
Arm Description
adult with severe SARS-CoV2 pneumonia
Intervention Type
Other
Intervention Name(s)
Blood sample and data record
Intervention Description
Blood sample and data record
Primary Outcome Measure Information:
Title
medium-term respiratory complications
Description
Interstitial lung disease diagnosed with a thoracic CT-scan
Time Frame
3 months
Secondary Outcome Measure Information:
Title
long-term respiratory complications
Description
Interstitial lung disease diagnosed with a thoracic CT-scan
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne-Marie PEROTIN-COLLARD
Phone
03 10 73 67 63
Email
jmperotin-collard@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne-Marie PEROTIN-COLLARD
Phone
03 10 73 67 63
Ext
0033
Email
jmperotin-collard@chu-reims.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
35918719
Citation
Perotin JM, Gierski F, Bolko L, Dury S, Barriere S, Launois C, Dewolf M, Chouabe S, Bongrain E, Picard D, Tran E, N'Guyen Y, Mourvillier B, Servettaz A, Rapin A, Marcus C, Lebargy F, Kaladjian A, Salmon JH, Deslee G. Cluster analysis unveils a severe persistent respiratory impairment phenotype 3-months after severe COVID-19. Respir Res. 2022 Aug 2;23(1):199. doi: 10.1186/s12931-022-02111-9.
Results Reference
derived
Learn more about this trial
Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia - COVID-19
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