One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia (CO-Qo-ICU) (CO-Qo-ICU)
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|ClinicalTrials.gov Identifier: NCT04401111|
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : September 25, 2020
Pneumonia caused by infection at SARS-CoV2 may be complicated by an acute respiratory detress syndrome need to take care in intensive care unit and can lead to mechanical ventilation. COVID-19 is a pandemic disease and lot of patients will survive of severe pneumoniae at SARS-CoV2 treat in ICU. At this time, there is no data about functional prognosis at long term.
This aim of this study is to evaluate the recovery of quality of life, respiratory function, neuromuscular function at long term and incidence of post-traumatic stress disorder. Patients will follow during 1year after out of ICU with 3 consultations at 3month, 6month and 12month. At each consultation patients will be evaluated about respiratory function, effort tolerance via 6minutes walking test, psychologic function with IES-R and HAD score and quality of life with SF36.
The hypothesis is that patients who survived of ARDS post infection at SARS-CoV2 have persistent functional limitation and alteration of quality of life one year after being discharged from the ICU.
|Condition or disease|
|COVID ARDS Quality of Life|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit|
|Actual Study Start Date :||June 16, 2020|
|Estimated Primary Completion Date :||June 15, 2021|
|Estimated Study Completion Date :||June 15, 2021|
Survivors of Intensive care unit patients
Survivors of severe COVID-19 pneumonia after intensive care unit
- Evaluation of recovery of quality of life in first year after ICU discharged in patients hospitalised for severe pneumonia at SARS-CoV2 [ Time Frame: 1 year ]The primary outcome is the score SF36 at 3month, 6month, 12 month after discharged of ICU in study population
- Evaluation of respiratory function during first year after ICU discharged in population studied [ Time Frame: 1 year ]Evaluation of functional respiratory exploratory
- Evaluation at 1 year of evolution of functional exercises capacity in population studied [ Time Frame: 1 year ]Mesure of the traveled distance in six-min walk test
- Evaluation of evolution of renal function during first year after ICU discharged in population studied [ Time Frame: 1 year ]Mesure of creatinine clairance and proteinuria
- Evaluation of evolution of right and left myocardic function during first year after ICU discharged in population studied [ Time Frame: 1 year ]Sudy of cardiac ultrasonography parameters
- Evaluation at 1 year of incidence of psychiatric pathology [ Time Frame: 1 year ]Occurence of post-traumatic stress disorder or anxious and depressive disorders in population studied
- Evaluation at 1 year of consequences in professional activity in population studied [ Time Frame: 1 year ]Rate of return to professional activity
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401111
|Contact: Clément SACCHERIfirstname.lastname@example.org|
|Contact: Jean DELLAMONICA, MD, PhDemail@example.com|