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Follow-up of Critical COVID-19 Patients (FUP-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04474249
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 20, 2020
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Uppföljning av Patienter Som intensivvårdats för COVID-19
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Group/Cohort
COVID-19
Patients with PCR-confirmed COVID-19 who were treated in the intensive care unit.



Primary Outcome Measures :
  1. Mortality [ Time Frame: Within 90 days after admission to ICU. ]
    Death

  2. Mortality [ Time Frame: Within 1 year after admission to ICU. ]
    Death

  3. Renal recovery [ Time Frame: At follow-up three to six months after ICU discharge. ]
    Return of renal function measured as CKD stage.

  4. Renal recovery [ Time Frame: At follow-up one year after ICU discharge. ]
    Return of renal function measured as CKD stage.

  5. Respiratory recovery [ Time Frame: Three to six months from discharge from ICU ]
    Respiratory function as assessed by a clinician

  6. Working capacity [ Time Frame: Three to six months from discharge from ICU ]
    6 min walk test

  7. Quality of life score [ Time Frame: Three to six months from discharge from ICU ]
    Quality of Life assessed using the 36-item short form survey by RAND.

  8. Cognitive recovery [ Time Frame: Three to six months from discharge from ICU ]
    Cognitive screening using the Montreal Cognitive Assessment.

  9. Frailty [ Time Frame: Three to six months from discharge from ICU ]
    Screening for frailty using the Clinical Frailty Scale-9.

  10. Activities of Daily Life [ Time Frame: Three to six months from discharge from ICU ]
    Screening of functional level for Activities of Daily Life using the 5-level EQ-5D.

  11. Anxiety [ Time Frame: Three to six months from discharge from ICU ]
    Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.

  12. Depression [ Time Frame: Three to six months from discharge from ICU ]
    Screening for depression using the Patient Health Questionnaire 9.

  13. Neurological recovery [ Time Frame: Three to six months from discharge from ICU ]
    Neurological function as assessed by a clinician


Biospecimen Retention:   Samples With DNA
Urine, Whole blood, Dried blood, Serum, EDTA-plasma, Citrate-plasma, cheek swab.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients admitted to ICU for COVID-19.
Criteria

Inclusion Criteria:

  • PCR-verified Covid-19
  • Treated in ICU

Exclusion Criteria:

  • Pregnant of breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474249


Contacts
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Contact: Michael Hultström, MD. PhD. +46186110000 michael.hultstrom@mcb.uu.se
Contact: Robert Frithiof, MD. PhD. +46186110000 robert.frithiof@surgsci.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Michael Hultström, MD. PhD.    +46186110000    michael.hultstrom@mcb.uu.se   
Contact: Robert Frithiof, MD. PhD.    +46186110000    robert.frithiof@surgsci.uu.se   
Sub-Investigator: Miklos Lipcsey, MD. PhD.         
Principal Investigator: Michael Hultström, MD. PhD.         
Sub-Investigator: Robert Frithiof, MD. PhD.         
Sub-Investigator: Sten Rubertsson, MD. PhD.         
Sub-Investigator: Ewa Wallin, PhD.         
Sub-Investigator: Ing-Marie Larsson, PhD.         
Sponsors and Collaborators
Uppsala University
Uppsala University Hospital
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT04474249    
Other Study ID Numbers: EPM-2020-02697
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
Corona virus
Acute Kidney Injury
SARS
Vasopressor
Respiratory failure
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Shock
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Pathologic Processes