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

Covid19 Clinical Trial

— COMEBAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704388
• Other study ID #: COMEBAC
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: March 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection

Locations

Country	Name	City	State
France	Bicêtre Hospital	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-intensive care syndrome (PICS)	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.	3 month after hospitalisation
Secondary	Evaluate the 3-month mortality of patients released alive from intensive care	Number of patient deceased	3 month after end of hospitalisation
Secondary	Describe the overall state of health and the main organ sequelae of these patients	Description of the data collected	3 month after hospitalisation
Secondary	functional respiratory sequelae	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.	3 month after hospitalisation

External Links

•   publication