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

Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; COVID; ARDS

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Clément SACCHERI; Phone Number: 0033492035510; Email: saccheri.c@chu-nice.fr
• Study Contact Backup: Name: Jean DELLAMONICA, MD, PhD; Phone Number: 0033492035510; Email: dellamonica.j@chu-nice.fr

Study Locations

• France
  • Nice, France, 06200
    • Recruiting
    • CHU de Nice
    • Contact: Jean DELLAMONICA; Email: dellamonica.j@chu-nice.fr
    • Contact: Clément SACCHERI; Email: saccheri.c@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for COVID-19 in Intensive care unit

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Survivors of Intensive care unit patients; Survivors of severe COVID-19 pneumonia after intensive care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19	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.	Vital and total lung capacity measurement when performing respiratory functional scans	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	Measurement of the extent of pulmonary parenchymal lesions when performing a chest CT scan at 3 months, 6 months, 1 year and 5 years of hospitalized patients in 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	Measurement of CKD score at 3 months, 6 months, 1 year and 5 years of hospitalized patient ICU for severe COVID-19. This score described in Appendix 2 is the recommended score for assessing resuscitation neuromyopathy	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	Measurement of left and right ventricular ejection fraction when performing a transthoracic cardiac ultrasound at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for a severe form of COVID-19	5 years
Psychological evaluation at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19	Evaluation des scores IES-R (Impact of Event Scale Revised) et HAD (Hospital Anxiety and Depression scale)	5 years
Evaluation of the possible impact on professional activity at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19	Measure the return to work rate (full-time, half-time, <half-time, none) at 3 months, 6 months, 1 year and 5 years of hospitalized Resuscitation for severe COVID-19.	5 years
Assessment of the 3-month, 6-month, 1-year and 5-year hospitalization rate for hospitalized patients with severe COVID-19.	The number of hospitalizations and the number of days spent in hospital at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.	5 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Six-minute walk test; Long term prognosis; Restrictive syndrom
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 20reamedcovid04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No Data sharing plan has been established

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No