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Mechanisms for Organ Dysfunction in Covid-19 (UMODCOVID19)

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: NCT04316884
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date March 13, 2020
First Posted Date March 20, 2020
Last Update Posted Date March 20, 2020
Actual Study Start Date March 12, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2020)		 Acute Kidney Injury [ Time Frame: During Intensive Care, an estimated average of 10 days. ]
KDIGO AKI score
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 18, 2020)
  • ARDS [ Time Frame: During intensive care, an estimated average of 10 days. ]
    Acute Respiratory Distress Syndrome yes/no
  • 30 day mortality [ Time Frame: 30 days ]
    Death within 30 days of ICU admission
  • 1 year mortality [ Time Frame: 1 year ]
    Death within 1 year of ICU admission
  • Chronic Kidney Disease [ Time Frame: 60 days and 1 year after ICU admission ]
    Development of Chronic Kidney Disease
  • SOFA-score [ Time Frame: During Intensive Care, an estimated average of 10 days. ]
    Sequential Organ Failure Score as a continuous variable
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mechanisms for Organ Dysfunction in Covid-19
Official Title Uppsala Intensive Care Study of Mechanisms for Organ Dysfunction in Covid-19
Brief Summary The study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.
Detailed Description Consenting patients with suspected or verified SARS-COV-2 infection, COVID-19, will undergo daily blood, urine and sputum sampling during their stay in intensive care. Data on organ dysfunction will be collected through the electronic patient journal and electronic patient data management system. The collected samples will be analysed for a panel of potential biomarkers that will be correlated to organ dysfunction and clinical outcome.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma, Urine and Sputum
Sampling Method Non-Probability Sample
Study Population All patients requiring intensive care with suspected or verified COVID19
Condition
  • COVID-19
  • Organ Dysfunction Syndrome Sepsis
  • Organ Dysfunction Syndrome, Multiple
  • Septic Shock
  • Acute Kidney Injury
  • Acute Respiratory Distress Syndrome
Intervention Not Provided
Study Groups/Cohorts COVID-19
Patients with suspected or verified COVID-19 admitted to intensive care at Uppsala University Hospital
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 18, 2020)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Admitted to intensive care
  • suspected or verified COVID-19

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Preexisting end-stage kidney failure or dialysis
  • Under-age
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Robert Frithiof, MD. PhD. 0736563473 robert.frithiof@surgsci.uu.se
Contact: Sara Bülow Anderberg, MD. 0730247414 sarabulow@gmail.com
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04316884
Other Study ID Numbers EPN 2017/043 Covid19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: IPD may be made available upon reasonable request.
Responsible Party Uppsala University
Study Sponsor Uppsala University
Collaborators Not Provided
Investigators
Principal Investigator: Robert Frithiof, MD. PhD Uppsala University Hospital
PRS Account Uppsala University
Verification Date March 2020