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

NCT04704388 | Completed

• 1 other identifier: COMEBAC
• Study Type: observational
• Target: 478
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate the 3-month mortality of patients released alive from intensive care

  3 month after end of hospitalisation

• Describe the overall state of health and the main organ sequelae of these patients

  3 month after hospitalisation

• functional respiratory sequelae

  3 month after hospitalisation

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patients having refused the post consultation at 3 month
• Without social security coverage

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

Related Publications (1)

• Pham T, Morin L, Savale L, Colle R, Figueiredo S, Harrois A, Gasnier M, Lecoq AL, Meyrignac O, Noel N, Abdo A, Baudry E, Bellin MF, Beurnier A, Choucha W, Corruble E, Dortet L, Gosset E, Hardy-Leger I, Quinque M, Radiguer F, Sportouch S, Verny C, Wyplosz B, Zaidan M, Becquemont L, Montani D, Monnet X. Four- and sixteen-month clinical status of a cohort of patients following hospitalization for COVID-19. Respir Med Res. 2024 Nov;86:101099. doi: 10.1016/j.resmer.2024.101099. Epub 2024 Mar 4.

  PMID: 38843604 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tài PHAM

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: June 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)