Clinical trial NCT04401111: One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia (CO-Qo-ICU)
Official title: Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID
ARDS
Quality of Life
Keywords: Long term prognosis
Six-minute walk test
Restrictive syndrom
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for COVID-19 in Intensive care unit

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in ICU for an ARDS table
* PCR SARSCoV-2 nasopharyngeal or positive pulmonary samples

Primary outcomes:
measure: Quality of life assessment at 3 months of stay in ICU patients hospitalized for a severe form of COVID-19
timeFrame: 5 years
Secondary outcomes:
measure: Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
measure: Stress-based assessment of respiratory function at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for severe COVID-19
timeFrame: 5 years
measure: Assessment of resuscitation neuromyopathy at 3 months, 6 months, 1 year and 5 years of hospitalized patients in Resuscitation for severe COVID-19
timeFrame: 5 years
measure: Left and Right Cardiac Function Assessment at 3 months, 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Assessment of the 3-month, 6-month, 1-year and 5-year hospitalization rate for hospitalized patients with severe COVID-19.
timeFrame: 5 years
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References: