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OpenTrials
Completed

NCT Number: NCT04704388

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: COMEBAC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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