Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)

NCT04491214 | Completed

• 1 other identifier: 7890
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Follow up; Rehabilitation

Keywords

SARS-CoV-2; Follow up; Intensive care unit; Cohort

Outcome Measures

Primary Outcomes (1)

• assess quality of life after severe COVID infection

  assess different dimensions of quality of life: physical and mentaland social dimensions

  measured at 3 months after ICU left.

Secondary Outcomes (1)

• Quality of life and Clinical status

  measured at 3 and 6 months after ICU left.

Interventions

quality of live assessment OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with severe SARS-Cov-2 hospitalized in intensive care.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)

Strasbourg, 67117, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 29, 2020
• Study Start: July 24, 2020
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: February 12, 2021

Record last verified: 2020-02

Locations

FR (1)