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

NCT ID: NCT04704388

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

478 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients hospitalized in intensive care units for SARS-CoV-2

patients hospitalized in intensive care units for SARS-CoV-2

No interventions assigned to this group

patients hospitalized outside intensive care units

patients hospitalized outside intensive care units

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tài PHAM

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38843604 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COMEBAC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CoV-PICS: A Virtual Post-ICU Clinic
NCT04490278 COMPLETED NA
SNUH MICU Cohort Study of PICS
NCT03216785 RECRUITING