FUP-COVID: Follow-up of Critical COVID-19 Patients

Sponsor

Uppsala University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04474249

Collaborator

Uppsala University Hospital (Other)

300

Enrollment

Location

29.2

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will follow COVID-19 patients who required intensive care after 3-6 months and one year after discharge from the ICU with functional level as well as organ function to assess recovery after COVID-19. Blood and urine will be collected for biobanking.

Condition or Disease	Intervention/Treatment	Phase
COVID19 ARDS AKI Circulatory Failure Coagulation Disorder Inflammatory Response

Detailed Description

The study will follow COVID-19 patients who required intensive care at Uppsala University Hospital and were included in the Uppsala COVID-19 biobank. The patients will be contacted after three to six months for a first follow-up with assessment of functional level in activities of daily life, psychiatric symptoms, neurological symptoms and working capacity as well as specific organ functions. The organ functions will include circulation, respiration, coagulation, immune function and kidney function. In addition, blood and urine will be collected for biobanking.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Uppföljning av Patienter Som intensivvårdats för COVID-19

Actual Study Start Date :

Jun 25, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 Patients with PCR-confirmed COVID-19 who were treated in the intensive care unit.

Outcome Measures

Primary Outcome Measures

Mortality [Within 90 days after admission to ICU.]
Death
Mortality [Within 1 year after admission to ICU.]
Death
Renal recovery [At follow-up three to six months after ICU discharge.]
Return of renal function measured as CKD stage.
Renal recovery [At follow-up one year after ICU discharge.]
Return of renal function measured as CKD stage.
Respiratory recovery [Three to six months from discharge from ICU]
Respiratory function as assessed by a clinician
Working capacity [Three to six months from discharge from ICU]
6 min walk test
Quality of life score [Three to six months from discharge from ICU]
Quality of Life assessed using the 36-item short form survey by RAND.
Cognitive recovery [Three to six months from discharge from ICU]
Cognitive screening using the Montreal Cognitive Assessment.
Frailty [Three to six months from discharge from ICU]
Screening for frailty using the Clinical Frailty Scale-9.
Activities of Daily Life [Three to six months from discharge from ICU]
Screening of functional level for Activities of Daily Life using the 5-level EQ-5D.
Anxiety [Three to six months from discharge from ICU]
Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.
Depression [Three to six months from discharge from ICU]
Screening for depression using the Patient Health Questionnaire 9.
Neurological recovery [Three to six months from discharge from ICU]
Neurological function as assessed by a clinician