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Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care (COMEBAC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04704388
Recruitment Status : Completed
First Posted : January 11, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia

Condition or disease
Covid19

Study Design
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Study Type : Observational
Actual Enrollment : 478 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

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Groups and Cohorts
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Group/Cohort
patients hospitalized in intensive care units for SARS-CoV-2
patients hospitalized in intensive care units for SARS-CoV-2
patients hospitalized outside intensive care units
patients hospitalized outside intensive care units


Outcome Measures
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Primary Outcome Measures :
  1. post-intensive care syndrome (PICS) [ Time Frame: 3 month after hospitalisation ]
    To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia.


Secondary Outcome Measures :
  1. Evaluate the 3-month mortality of patients released alive from intensive care [ Time Frame: 3 month after end of hospitalisation ]
    Number of patient deceased

  2. Describe the overall state of health and the main organ sequelae of these patients [ Time Frame: 3 month after hospitalisation ]
    Description of the data collected

  3. functional respiratory sequelae [ Time Frame: 3 month after hospitalisation ]
    Compare the functional respiratory sequelae of these patients to those who were hospitalized outside of critical care for COVID-19 pneumonia requiring lower oxygen support.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Paitent admitted between March 1 and May 10, 2020 in Bicêtre hospital for an infection with SARS-CoV-2
Criteria

Inclusion Criteria:

-

Group 1: patients hospitalized in intensive care units for ARDS with SARS-CoV-2

  • Major
  • Admitted between March 1 and May 10, 2020 in one of the sectors of the Bicêtre hospital approved for critical care
  • proven SARS-CoV-2 infection
  • Treated by invasive mechanical ventilation or high flow humidified oxygen with FiO2 ≥50% for more than 48 hours.

Group 2: patients hospitalized outside intensive care units

  • Major
  • Admitted between March 1 and May 10, 2020 in an area of Bicêtre hospital having cared for patients infected with SARS-CoV-2 excluding critical care: pulmonology, internal medicine / orthopedics, infectious diseases, nephrology , acute geriatrics, neurology.

Exclusion Criteria:

  • Patients having refused the post consultation at 3 month
  • Without social security coverage
Contacts and Locations
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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): NCT04704388


Locations
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France
Bicêtre Hospital
Le Kremlin-Bicêtre, France, 94270
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Tài PHAM APHP
More Information
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Additional Information:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04704388    
Other Study ID Numbers: COMEBAC
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases