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Clinical Trials/NCT04609839
NCT04609839
Withdrawn
Not Applicable

TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.

University Hospital, Strasbourg, France1 site in 1 country200 target enrollmentSeptember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Admitted to Intensive Care Unit for COVID-19
Sponsor
University Hospital, Strasbourg, France
Enrollment
200
Locations
1
Primary Endpoint
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.
Status
Withdrawn
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
October 17, 2023
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.

Secondary Outcomes

  • 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)

Study Sites (1)

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