Follow-up of Critical COVID-19 Patients

COVID19 Clinical Trial

— FUP-COVID  

Official title:

Uppföljning av Patienter Som intensivvårdats för COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474249
• Other study ID #: EPM-2020-02697
• Status: Recruiting
• Start date: June 25, 2020
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Uppsala University
• Contact: Michael Hultström, MD. PhD.
• Phone: +46186110000
• Email: michael.hultstrom[@]mcb.uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PCR-verified Covid-19

• Treated in ICU

Exclusion Criteria:

• Pregnant of breastfeeding

Related Conditions & MeSH terms

• AKI
• ARDS
• Blood Coagulation Disorders
• Circulatory Failure
• Coagulation Disorder
• COVID-19
• COVID19
• Hemostatic Disorders
• Inflammatory Response
• Shock

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

E E, R F, Öi E, Im L, M L, S R, E W, C J, M H, A M. Impaired diffusing capacity for carbon monoxide is common in critically ill Covid-19 patients at four months post-discharge. Respir Med. 2021 Jun;182:106394. doi: 10.1016/j.rmed.2021.106394. Epub 2021 Ap — View Citation

Hultström M, Lipcsey M, Wallin E, Larsson IM, Larsson A, Frithiof R. Severe acute kidney injury associated with progression of chronic kidney disease after critical COVID-19. Crit Care. 2021 Jan 25;25(1):37. doi: 10.1186/s13054-021-03461-4. — View Citation

Outcome

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