One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia (CO-Qo-ICU)

NCT04401111 | Unknown

• 1 other identifier: 20reamedcovid04
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairment require prolonged intensive care that can be complicated in the short term, In the medium and long term, physical and psychological sequelae can affect patients' quality of life and prevent a return to normal working life. To date, there is little data on the fate of patients treated in Resuscitation for a severe form of COVID-19, both in terms of respiratory sequelae, as well as in terms of psychological sequelae and their quality of life. The objective of this study is to be able to describe and evaluate the possible physical and psychological sequelae and quality of life of patients hospitalized in Resuscitation for a severe form of COVID-19 in the short (3 and 6 months), medium (1 year) and long (5 years) End of their stay in ICU. To do this, we want to carry out a prospective, observational and monocentric study in the consultation department of the Nice CHU. All patients admitted to Resuscitation for a severe form of COVID-19 who have accepted the longitudinal medical follow-up proposed by the Nice CHU will be included in the study and data from the computerized medical record will be analyzed.

Conditions

COVID; ARDS; Quality of Life

Keywords

Long term prognosis; Six-minute walk test; Restrictive syndrom

Outcome Measures

Primary Outcomes (1)

• Quality of life assessment at 3 months of stay in ICU patients hospitalized for a severe form of COVID-19

  SF-36 score calculation at 3 months of inpatient ICU stay for severe COVID-19

  5 years

Secondary Outcomes (8)

• Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19

  5 years

• Assessment of respiratory function and lung lesions at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.

  5 years

• Stress-based assessment of respiratory function at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for severe COVID-19

  5 years

• Assessment of resuscitation neuromyopathy at 3 months, 6 months, 1 year and 5 years of hospitalized patients in Resuscitation for severe COVID-19

  5 years

• Left and Right Cardiac Function Assessment at 3 months, 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19

  5 years

Study Arms (1)

Survivors of Intensive care unit patients

Survivors of severe COVID-19 pneumonia after intensive care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for COVID-19 in Intensive care unit

You may qualify if:

• Patients hospitalized in ICU for an ARDS table
• PCR SARSCoV-2 nasopharyngeal or positive pulmonary samples

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06200, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

Central Study Contacts

Clément SACCHERI

CONTACT

0033492035510; saccheri.c@chu-nice.fr

Jean DELLAMONICA, MD, PhD

CONTACT

0033492035510; dellamonica.j@chu-nice.fr

Study Design

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

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 26, 2020
• Study Start: June 16, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)