- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491214
Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Strasbourg, France, 67117
- Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assess quality of life after severe COVID infection
Time Frame: measured at 3 months after ICU left.
|
assess different dimensions of quality of life: physical and mentaland social dimensions
|
measured at 3 months after ICU left.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life and Clinical status
Time Frame: measured at 3 and 6 months after ICU left.
|
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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7890
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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