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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04376840
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Severe SARS-CoV2 Pneumonia Other: Blood sample and data record Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : January 28, 2022
Estimated Study Completion Date : October 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: adults with severe SARS-CoV2 pneumonia
adult with severe SARS-CoV2 pneumonia
Other: Blood sample and data record
Blood sample and data record




Primary Outcome Measures :
  1. medium-term respiratory complications [ Time Frame: 3 months ]
    Interstitial lung disease diagnosed with a thoracic CT-scan


Secondary Outcome Measures :
  1. long-term respiratory complications [ Time Frame: 12 months ]
    Interstitial lung disease diagnosed with a thoracic CT-scan



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376840


Contacts
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Contact: Jeanne-Marie PEROTIN-COLLARD 03 10 73 67 63 jmperotin-collard@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Jeanne-Marie PEROTIN-COLLARD    03 10 73 67 63 ext 0033    jmperotin-collard@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT04376840    
Other Study ID Numbers: PO20066
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
SARS-CoV2
long term
complication
pneumonia
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections