Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)

Covid19 Clinical Trial

Official title:

Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491214
• Other study ID #: 7890
• Status: Completed
• Start date: July 24, 2020
• Est. completion date: January 21, 2021

Study information

• Verified date: February 2020
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization.

Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will be able to follow up patients and perform complementary investigations according to patients injuries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Subject male or female = 18 years old

• Patient hospitalized in the anesthesia-resuscitation department of the NHC for COVID-19 from March 1, 2020.

• Patient (or his legal representative) having given his consent for the use of his data for the purposes of this research.

exclusion criteria:

• Subject not hospitalized in intensive care

• Patient's refusal to participate in the study

• Inability to give informed information to the subject (subject in an emergency, difficulty understanding the subject, etc.)

• Subject under low protection

Related Conditions & MeSH terms

• Covid19
• Follow up
• Infection
• Rehabilitation

Intervention

Other:
• quality of live assessment
quality of live assessment 3 moth and 6 moth after ointensive care hospitalisation using SF36.

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess quality of life after severe COVID infection	assess different dimensions of quality of life: physical and mentaland social dimensions	measured at 3 months after ICU left.
Secondary	Quality of life and Clinical status	Clinical status of patients and assessment of quality of life. collects crucial elements of care based on doctors' prescriptions	measured at 3 and 6 months after ICU left.