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

October 18, 2021 updated by: Uppsala University

Uppföljning av Patienter Som intensivvårdats för COVID-19

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Recruiting
        • Uppsala University Hospital
        • Contact:
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to ICU for COVID-19.

Description

Inclusion Criteria:

  • PCR-verified Covid-19
  • Treated in ICU

Exclusion Criteria:

  • Pregnant of breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Within 90 days after admission to ICU.
Death
Within 90 days after admission to ICU.
Mortality
Time Frame: Within 1 year after admission to ICU.
Death
Within 1 year after admission to ICU.
Renal recovery
Time Frame: At follow-up three to six months after ICU discharge.
Return of renal function measured as CKD stage.
At follow-up three to six months after ICU discharge.
Renal recovery
Time Frame: At follow-up one year after ICU discharge.
Return of renal function measured as CKD stage.
At follow-up one year after ICU discharge.
Respiratory recovery
Time Frame: Three to six months from discharge from ICU
Respiratory function as assessed by a clinician
Three to six months from discharge from ICU
Working capacity
Time Frame: Three to six months from discharge from ICU
6 min walk test
Three to six months from discharge from ICU
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.
Three to six months from discharge from ICU
Cognitive recovery
Time Frame: Three to six months from discharge from ICU
Cognitive screening using the Montreal Cognitive Assessment.
Three to six months from discharge from ICU
Frailty
Time Frame: Three to six months from discharge from ICU
Screening for frailty using the Clinical Frailty Scale-9.
Three to six months from discharge from ICU
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.
Three to six months from discharge from ICU
Anxiety
Time Frame: Three to six months from discharge from ICU
Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.
Three to six months from discharge from ICU
Depression
Time Frame: Three to six months from discharge from ICU
Screening for depression using the Patient Health Questionnaire 9.
Three to six months from discharge from ICU
Neurological recovery
Time Frame: Three to six months from discharge from ICU
Neurological function as assessed by a clinician
Three to six months from discharge from ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPM-2020-02697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be shared on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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