FOLLOW-UP OF PATIENTS WITH COVID-19.

• Conditions: Patient Admitted to Intensive Care Unit for COVID-19
• Interventions: Other: Follow-up of patients with COVID-19

• Registration Number: NCT04609839
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.

The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-26
• Study Start: 2020-10-27
• Study First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-10-30
• Primary Completion: 2023-04-27
• Study Completion: 2023-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient admitted to intensive care unit for COVID-19
• Adult patient ≥ 18 years old
• Subject having expressed his non-opposition to the research
• Subject affiliated to a social health insurance protection scheme or beneficiary of such a scheme

Exclusion Criteria

• Subject under safeguard of justice
• Patient under guardianship or curatorship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient admitted to intensive care unit for COVID-19	Follow-up of patients with COVID-19	-

Primary Outcome Measures

Name	Time	Method
The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care.	The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.

Secondary Outcome Measures

Name	Time	Method
4.1) Quality of life score (SF-36 questionnaire) at 3, 6 and 12 months	At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
3) Date of death	Date of death will be collected from inclusion to M12 (12 months after patient inclusion)
5) Cost of health expenditure	The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion)
1) The sequelae by type of impairment will be assessed by specialist doctors at 3, 6 and 12 months	At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
2) Number of re-hospitalizations at 3, 6 and 12 months	At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
4.2) The Pittsburgh sleep quality index (PSQI questionnaire) at 3, 6 and 12 months	At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion

Trial Locations

Locations (1)

Hopitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France