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NCT Number: NCT04401111

One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia (CO-Qo-ICU)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID ARDS Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, 06200, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Quality of life assessment at 3 months of stay in ICU patients hospitalized for a severe form of COVID-19

    Time frame: 5 years

    SF-36 score calculation at 3 months of inpatient ICU stay for severe COVID-19

Secondary outcomes

  1. Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19

    Time frame: 5 years

    Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19

  2. 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.

    Time frame: 5 years

    Vital and total lung capacity measurement when performing respiratory functional scans

  3. Stress-based assessment of respiratory function at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for severe COVID-19

    Time frame: 5 years

    Measurement of the extent of pulmonary parenchymal lesions when performing a chest CT scan at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19

  4. Assessment of resuscitation neuromyopathy at 3 months, 6 months, 1 year and 5 years of hospitalized patients in Resuscitation for severe COVID-19

    Time frame: 5 years

    Measurement of CKD score at 3 months, 6 months, 1 year and 5 years of hospitalized patient ICU for severe COVID-19. This score described in Appendix 2 is the recommended score for assessing resuscitation neuromyopathy

  5. Left and Right Cardiac Function Assessment at 3 months, 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19

    Time frame: 5 years

    Measurement of left and right ventricular ejection fraction when performing a transthoracic cardiac ultrasound at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for a severe form of COVID-19

  6. 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

    Time frame: 5 years

    Evaluation des scores IES-R (Impact of Event Scale Revised) et HAD (Hospital Anxiety and Depression scale)

  7. 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

    Time frame: 5 years

    Measure the return to work rate (full-time, half-time, <half-time, none) at 3 months, 6 months, 1 year and 5 years of hospitalized Resuscitation for severe COVID-19.

  8. Assessment of the 3-month, 6-month, 1-year and 5-year hospitalization rate for hospitalized patients with severe COVID-19.

    Time frame: 5 years

    The number of hospitalizations and the number of days spent in hospital at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit

Acronym: CO-Qo-ICU

Important dates

Study start
2020
Primary completion
2029
Study completion
2029
First posted
May 26, 2020
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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