NCT04474249

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

June 29, 2020

Last Update Submit

October 18, 2021

Conditions

COVID19ARDSAKICirculatory FailureCoagulation DisorderInflammatory Response

Keywords

Corona virusAcute Kidney InjurySARSVasopressorRespiratory failure

Outcome Measures

Primary Outcomes (13)

  • Mortality

    Death

    Within 90 days after admission to ICU.

  • Mortality

    Death

    Within 1 year after admission to ICU.

  • Renal recovery

    Return of renal function measured as CKD stage.

    At follow-up three to six months after ICU discharge.

  • Renal recovery

    Return of renal function measured as CKD stage.

    At follow-up one year after ICU discharge.

  • Respiratory recovery

    Respiratory function as assessed by a clinician

    Three to six months from discharge from ICU

  • Working capacity

    6 min walk test

    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.

    Three to six months from discharge from ICU

  • Cognitive recovery

    Cognitive screening using the Montreal Cognitive Assessment.

    Three to six months from discharge from ICU

  • Frailty

    Screening for frailty using the Clinical Frailty Scale-9.

    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.

    Three to six months from discharge from ICU

  • Anxiety

    Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.

    Three to six months from discharge from ICU

  • Depression

    Screening for depression using the Patient Health Questionnaire 9.

    Three to six months from discharge from ICU

  • Neurological recovery

    Neurological function as assessed by a clinician

    Three to six months from discharge from ICU

Study Arms (1)

COVID-19

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to ICU for COVID-19.

You may qualify if:

  • PCR-verified Covid-19
  • Treated in ICU

You may not qualify if:

  • Pregnant of breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

Related Publications (6)

  • 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.

    PMID: 33901787RESULT

  • Hultstrom 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.

    PMID: 33494766RESULT

  • Bjarnadottir 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.

    PMID: 39050483DERIVED

  • Halvorsen 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.

    PMID: 37865685DERIVED

  • Bark 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.

    PMID: 37573366DERIVED

  • Hultstrom 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.

    PMID: 36271419DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine, Whole blood, Dried blood, Serum, EDTA-plasma, Citrate-plasma, cheek swab.

MeSH Terms

Conditions

COVID-19ShockHemostatic DisordersAcute Kidney InjuryRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiration Disorders

Central Study Contacts

Michael Hultström, MD. PhD.

CONTACT

+46186110000michael.hultstrom@mcb.uu.se

Robert Frithiof, MD. PhD.

CONTACT

+46186110000robert.frithiof@surgsci.uu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 16, 2020

Study Start

June 25, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

SE(1)