Follow-up of Critical COVID-19 Patients

• Conditions: AKI; Coagulation Disorder; Circulatory Failure; Inflammatory Response; COVID19; ARDS

• Registration Number: NCT04474249
• Lead Sponsor: Uppsala University

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.

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 Timeline

• Study Start: 2020-06-25
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-16
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-26
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• PCR-verified Covid-19
• Treated in ICU

Exclusion Criteria

• Pregnant of breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Within 1 year after admission to ICU.	Death
Anxiety	Three to six months from discharge from ICU	Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.
Renal recovery	At follow-up one year after ICU discharge.	Return of renal function measured as CKD stage.
Frailty	Three to six months from discharge from ICU	Screening for frailty using the Clinical Frailty Scale-9.
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.
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.
Neurological recovery	Three to six months from discharge from ICU	Neurological function as assessed by a clinician
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
Cognitive recovery	Three to six months from discharge from ICU	Cognitive screening using the Montreal Cognitive Assessment.
Depression	Three to six months from discharge from ICU	Screening for depression using the Patient Health Questionnaire 9.

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden