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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort
Survivors of Intensive care unit patients
Survivors of severe COVID-19 pneumonia after intensive care unit



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evaluation of respiratory function during first year after ICU discharged in population studied [ Time Frame: 1 year ]
    Evaluation of functional respiratory exploratory

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for COVID-19 in Intensive care unit
Criteria

Inclusion Criteria:

All consecutive patients with COVID-19 pneumina with hypoxemia (need >6L/min d'O2) admitted to the ICU and survived of ICU will be included. Patients under 18 years or under guardianship will be excluded


Information from the National Library of Medicine

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


Contacts
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Contact: Clément SACCHERI 0033492035510 saccheri.c@chu-nice.fr
Contact: Jean DELLAMONICA, MD, PhD 0033492035510 dellamonica.j@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France, 06200
Contact: Clément SACCHERI       saccheri.c@chu-nice.fr   
Contact: Jean DELLAMONICA       dellamonica.j@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04401111    
Other Study ID Numbers: 20reamedcovid04
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Data sharing plan has been established

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
Long term prognosis
Six-minute walk test
Restrictive syndrom
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections