COVID19FUP-COVIDNCT04474249
Follow-up of Critical COVID-19 Patients
An observational study of COVID19 and ARDS, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jun 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to ICU for COVID-19.
Who may be able to join
- PCR-verified Covid-19
- Treated in ICU
Who cannot join
- Pregnant of breastfeeding
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, 75185
Michael Hultström, MD. PhD., +46186110000, michael.hultstrom@mcb.uu.se
Robert Frithiof, MD. PhD., +46186110000, robert.frithiof@surgsci.uu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID19, ARDS, AKI, Circulatory Failure, Coagulation Disorder, Inflammatory Response
- Keywords
- Corona virus, Acute Kidney Injury, SARS, Vasopressor, Respiratory failure
- Medical subject headings
- COVID-19, Shock, Hemostatic Disorders, Acute Kidney Injury, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Patients with PCR-confirmed COVID-19 who were treated in the intensive care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death
Measured: Within 90 days after admission to ICU.
Mortality
Death
Measured: Within 1 year after admission to ICU.
Renal recovery
Return of renal function measured as CKD stage.
Measured: At follow-up three to six months after ICU discharge.
Renal recovery
Return of renal function measured as CKD stage.
Measured: At follow-up one year after ICU discharge.
Respiratory recovery
Respiratory function as assessed by a clinician
Measured: Three to six months from discharge from ICU
Working capacity
6 min walk test
Measured: Three to six months from discharge from ICU
Quality of life score
Quality of Life assessed using the 36-item short form survey by RAND.
Measured: Three to six months from discharge from ICU
Cognitive recovery
Cognitive screening using the Montreal Cognitive Assessment.
Measured: Three to six months from discharge from ICU
Frailty
Screening for frailty using the Clinical Frailty Scale-9.
Measured: Three to six months from discharge from ICU
Activities of Daily Life
Screening of functional level for Activities of Daily Life using the 5-level EQ-5D.
Measured: Three to six months from discharge from ICU
Anxiety
Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.
Measured: Three to six months from discharge from ICU
Depression
Screening for depression using the Patient Health Questionnaire 9.
Measured: Three to six months from discharge from ICU
Neurological recovery
Neurological function as assessed by a clinician
Measured: Three to six months from discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start25 Jun 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474249
- Sponsor's protocol ID
- EPM-2020-02697
- Acronym
- FUP-COVID
- Status last verified
- Oct 2021
- First submitted
- 29 Jun 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared on reasonable request.
Publications
E E, R F, Oi 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 Apr 15.
PubMed 33901787Hultstrom 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. No abstract available.
PubMed 33494766Bjarnadottir KJ, Perchiazzi G, Sidenbladh CL, Larina A, Wallin E, Larsson IM, Franzen S, Larsson AO, Sousa MLA, Segelsjo M, Hansen T, Frithiof R, Hultstrom M, Lipcsey M, Pellegrini M. Body mass index is associated with pulmonary gas and blood distribution mismatch in COVID-19 acute respiratory failure. A physiological study. Front Physiol. 2024 Jul 10;15:1399407. doi: 10.3389/fphys.2024.1399407. eCollection 2024.
PubMed 39050483Halvorsen P, Hultstrom M, Hastbacka J, Larsson IM, Eklund R, Arnberg FK, Hokkanen L, Frithiof R, Wallin E, Orwelius L, Lipcsey M. Health-related quality of life after surviving intensive care for COVID-19: a prospective multicenter cohort study. Sci Rep. 2023 Oct 21;13(1):18035. doi: 10.1038/s41598-023-45346-2.
PubMed 37865685Bark L, Larsson IM, Wallin E, Simren J, Zetterberg H, Lipcsey M, Frithiof R, Rostami E, Hultstrom M. Central nervous system biomarkers GFAp and NfL associate with post-acute cognitive impairment and fatigue following critical COVID-19. Sci Rep. 2023 Aug 12;13(1):13144. doi: 10.1038/s41598-023-39698-y.
PubMed 37573366Hultstrom M, Lipcsey M, Morrison DR, Nakanishi T, Butler-Laporte G, Chen Y, Yoshiji S, Forgetta V, Farjoun Y, Wallin E, Larsson IM, Larsson A, Marton A, Titze JM, Nihlen S, Richards JB, Frithiof R. Dehydration is associated with production of organic osmolytes and predicts physical long-term symptoms after COVID-19: a multicenter cohort study. Crit Care. 2022 Oct 21;26(1):322. doi: 10.1186/s13054-022-04203-w.
PubMed 36271419
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uppföljning av Patienter Som intensivvårdats för COVID-19
- ClinicalTrials.gov ID
- NCT04474249
- Acronym / sponsor ID
- FUP-COVID / EPM-2020-02697
- Conditions
- COVID19, ARDS, AKI, Circulatory Failure, Coagulation Disorder, Inflammatory Response
- Keywords
- Corona virus, Acute Kidney Injury, SARS, Vasopressor, Respiratory failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | –Patients with PCR-confirmed COVID-19 who were treated in the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to ICU for COVID-19.
Key inclusion criteria (2 listed)
- PCR-verified Covid-19
- Treated in ICU
Key exclusion criteria (1 listed)
- Pregnant of breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Within 90 days after admission to ICU.
Death
Mortality
Time frame: Within 1 year after admission to ICU.
Death
Renal recovery
Time frame: At follow-up three to six months after ICU discharge.
Return of renal function measured as CKD stage.
Renal recovery
Time frame: At follow-up one year after ICU discharge.
Return of renal function measured as CKD stage.
Respiratory recovery
Time frame: Three to six months from discharge from ICU
Respiratory function as assessed by a clinician
Working capacity
Time frame: Three to six months from discharge from ICU
6 min walk test
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.
Cognitive recovery
Time frame: Three to six months from discharge from ICU
Cognitive screening using the Montreal Cognitive Assessment.
Frailty
Time frame: Three to six months from discharge from ICU
Screening for frailty using the Clinical Frailty Scale-9.
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.
Anxiety
Time frame: Three to six months from discharge from ICU
Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.
Depression
Time frame: Three to six months from discharge from ICU
Screening for depression using the Patient Health Questionnaire 9.
Neurological recovery
Time frame: Three to six months from discharge from ICU
Neurological function as assessed by a clinician
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Results publication: PubMed 33901787E E, R F, Oi 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 Apr 15.
- Results publication: PubMed 33494766Hultstrom 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. No abstract available.
- Derived from this study: PubMed 39050483Bjarnadottir KJ, Perchiazzi G, Sidenbladh CL, Larina A, Wallin E, Larsson IM, Franzen S, Larsson AO, Sousa MLA, Segelsjo M, Hansen T, Frithiof R, Hultstrom M, Lipcsey M, Pellegrini M. Body mass index is associated with pulmonary gas and blood distribution mismatch in COVID-19 acute respiratory failure. A physiological study. Front Physiol. 2024 Jul 10;15:1399407. doi: 10.3389/fphys.2024.1399407. eCollection 2024.
- Derived from this study: PubMed 37865685Halvorsen P, Hultstrom M, Hastbacka J, Larsson IM, Eklund R, Arnberg FK, Hokkanen L, Frithiof R, Wallin E, Orwelius L, Lipcsey M. Health-related quality of life after surviving intensive care for COVID-19: a prospective multicenter cohort study. Sci Rep. 2023 Oct 21;13(1):18035. doi: 10.1038/s41598-023-45346-2.
- Derived from this study: PubMed 37573366Bark L, Larsson IM, Wallin E, Simren J, Zetterberg H, Lipcsey M, Frithiof R, Rostami E, Hultstrom M. Central nervous system biomarkers GFAp and NfL associate with post-acute cognitive impairment and fatigue following critical COVID-19. Sci Rep. 2023 Aug 12;13(1):13144. doi: 10.1038/s41598-023-39698-y.
- Derived from this study: PubMed 36271419Hultstrom M, Lipcsey M, Morrison DR, Nakanishi T, Butler-Laporte G, Chen Y, Yoshiji S, Forgetta V, Farjoun Y, Wallin E, Larsson IM, Larsson A, Marton A, Titze JM, Nihlen S, Richards JB, Frithiof R. Dehydration is associated with production of organic osmolytes and predicts physical long-term symptoms after COVID-19: a multicenter cohort study. Crit Care. 2022 Oct 21;26(1):322. doi: 10.1186/s13054-022-04203-w.
- Individual participant dataSharing planned: Undecided. Data will be shared on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19 and ARDS, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Hultström, MD. PhD. (+46186110000, michael.hultstrom@mcb.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Within 90 days after admission to ICU.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474249, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.