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

Quality of Life Clinical Trial

— CO-Qo-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04401111
• Other study ID #: 20reamedcovid04
• Status: Recruiting
• Start date: June 16, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Clément SACCHERI
• Phone: 0033492035510
• Email: saccheri.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalized in ICU for an ARDS table

• PCR SARSCoV-2 nasopharyngeal or positive pulmonary samples

Related Conditions & MeSH terms

• ARDS
• COVID
• Pneumonia
• Quality of Life

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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,	5 years
Secondary	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