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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04474249
Other study ID # EPM-2020-02697
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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