Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Renal Outcome in Patients With COVID-19

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: NCT04353583
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
University of Giessen

Brief Summary:
Acute kidney injury (AKI) is reported to occur in 0.5-9% of severe acute respiratory distress coronavirus 2-positive patients and AKI has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of renal outcome of in-hospital patients diagnosed with COVID-19.

Condition or disease
Acute Kidney Injury Corona Virus Infection

Detailed Description:
Beginning in December 2019, a novel coronavirus, designated as severe acute respiratory distress coronavirus 2 (SARS-CoV-2), has caused an international outbreak of respiratory illness termed coronavirus disease 2019 (COVID-19). Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients show severe kidney abnormalities. Acute kidney injury (AKI) is reported to occur in 0.5-9% of SARS-CoV-2 positive patients and AKI has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of of renal outcome of in-hospital patients diagnosed with COVID-19.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Renal Outcome in Patients With Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
ICU patients
Patients with COVID-19 requiring ICU care
Non-ICU patients
In-hospital patients with COVID-19 not requiring ICU care



Primary Outcome Measures :
  1. GFR loss [ Time Frame: 6 months post-hospital admission ]
    Serial assessment of serum creatinine and cystatin C

  2. Cystatin C as indicator of mortality [ Time Frame: 30 days post-hospital admission ]
    All-cause mortality

  3. Cystatin C as indicator of respiratory illness [ Time Frame: 30 days post-hospital admission ]
    Ventilator-free days

  4. Cystatin C as indicator of disease severity [ Time Frame: 30 days post-hospital admission ]
    Rate of intensive care unit admission


Secondary Outcome Measures :
  1. Renal function changes during hospital stay [ Time Frame: from hospital admission til discharge up to 6 months ]
    Serial biomarker assessment

  2. Incidence of AKI [ Time Frame: Within 7 days after admission ]
    As determined by KDIGO criteria



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitalized patients with diagnosed COVID-19
Criteria

Inclusion Criteria:

  • Patients with COVID-19 diagnosed by World Health Organisation (WHO) criteria

Exclusion Criteria:

  • Patients aged less than 18 years
  • Patients with stage-5 chronic kidney disease
  • Patients receiving maintenance dialysis
  • Recipients of solid-organ transplantation
  • Patients with AKI requiring renal replacement therapy

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): NCT04353583


Contacts
Layout table for location contacts
Contact: Faeq Husain-Syed, MD +49 641 985 42378 faeq.husain-syed@innere.med.uni-giessen.de
Contact: Horst-Walter Birk, MD +49 641 985 42378 horst-walter.birk@innere.med.uni-giessen.de

Locations
Layout table for location information
Germany
University Hospital Giessen and Marburg, Giessen Recruiting
Giessen, Hessen, Germany, 35382
Sponsors and Collaborators
University of Giessen
Investigators
Layout table for investigator information
Study Director: Werner Seeger, MD University Hospital Giessen and Marburg, Giessen
Publications of Results:
Layout table for additonal information
Responsible Party: University of Giessen
ClinicalTrials.gov Identifier: NCT04353583    
Other Study ID Numbers: AZ 58/20
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Virus Diseases
Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections