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OpenTrials
Completed

NCT Number: 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Follow up Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Rehabilitation Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)

Strasbourg, 67117, France

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

quality of live assessment

Other

quality of live assessment 3 moth and 6 moth after ointensive care hospitalisation using SF36.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2020
Registry last updated
Feb 12, 2021

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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