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CompletedNCT04797091KidneyCOVID19Updated Dec 17, 2025

Kidney in Coronavirus Disease 2019 Registry

An observational study in Corona Virus Infection and SARS-CoV 2, sponsored by University of Cologne. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by University of Cologne · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500
Sex
All
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Study summary

The SARS-CoV-2 virus is a virus newly identified in January 2020. The WHO defined COVID-19 as a health emergency of international importance. The clinical manifestation of the COVID-19 disease cannot be fully described in the short time.

First insights in patients suffering from acute kidney injury (AKI) during COVID-19 indicate severe course with high mortality. The locally varying spread of SARS CoV-2 infection requires a better understanding of clinical course of COVID-19 in order to be able to establish future treatment approaches.

The examination of attributable mortality and costs of COVID-19 will need to be studied on a multinational basis and therefore Kidney in COVID-19 Registry will particularly use a matched case control design.

Read the detailed description

The SARS-CoV-2 virus is a virus newly identified in January 2020 in Wuhan, China, which belongs to the group of coronaviruses and causes COVID-19. Due to the rapid spread worldwide, high morbidity and virulence the of causing SARS-CoV-2 , the WHO defined COVID-19 as a health emergency of international importance in February 2020. Due to the rapid spread of the new virus, a comprehensive understanding of the transmission, the course of the disease, the diagnosis and the therapeutic regimen is of the utmost importance. Initial case reports indicate that human-to-human transmission takes place through droplet infection. In contrast to previously known infections from the group of coronaviruses, the SARS-CoV-2 virus has a high ability to infect with already mild symptoms resulting in frequent outbreak situation of worldwide importance. Furthermore, high viral loads are found in the upper respiratory tract of infected people leading to the high virulence of causing SARS-CoV-2. The clinical manifestation of the COVID-19 disease cannot be fully described in the short time. However, symptoms of SARS-CoV-2 virus infection are described with mild symptoms like fever, muscle pain, and dry cough as well as severe complications like virus pneumonia, Acute Respiratory Distress Syndrome (ARDS) and death. Interestingly older and chronically ill patients in particular have a severe course of COVID-19 with intensive care treatment and high mortality. At present, there is no specific therapy available for COVID-19. Treatment approaches are primarily supportive with admission of patients to the intensive care unit (ICU), mechanical ventilation, extracorporeal membrane oxygenation (ECMO) and maintenance of fluid and electrolyte balance. Patients with severe renal insufficiency and fluid retention, pulmonary edema or hyperkalemia may require dialysis. First insights in patients suffering from acute kidney injury (AKI) during COVID-19 indicate severe course with high mortality. First case reports do not describe a beneficial effect of antiviral therapy. The locally varying spread of SARS CoV-2 infection requires a better understanding of clinical course of COVID-19 in order to be able to establish future treatment approaches. Investigators have to attach great importance to high-risk cohorts like patients suffering from chronic renal disease with many comorbidities or patients after kidney transplantation under immunosuppressive drug treatment. Although COVID-19 has been studied for only a few month it is known that especially these patients develop a severe clinical course. Due to increasingly frequent outbreak situations and globally chances in species distributions, local, as well as worldwide surveillances in epidemiology and species distribution are urgently needed. As the clinical course of COVID-19 disease is dependent on the causing viral pathogen and the full picture of clinical manifestation is not yet understand further studies with regard to the disease course are mandatory.

Additionally, the examination of attributable mortality and costs of COVID-19 will need to be studied on a multinational basis and therefore Kidney in COVID-19 Registry will particularly use a matched case control design.

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Conditions studied

  • Corona Virus Infection
  • SARS-CoV 2
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In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 500 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Particularly, controls will be identified retrospectively at the same hospitals that based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).

Inclusion criteria

  • Virology evidence of SARS-CoV-2-infection
  • Pathological evidence of SARS-CoV-2-infection

Exclusion criteria

Exclusion Criteria:

  • Occurrence of ARDS (acute respiratory distress syndrome) without evidence of SARS-CoV-2 infection
  • Acute kidney injury without evidence of SARS-CoV-2 infection
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with SARS-CoV-2-infection

    Patients with evidence of SARS-CoV-2-infection

    Other: Retrospective data collection

  • Control group

    Controls will be identified retrospectively at the same hospitals that based on matching of demographics, underlying diseases and duration of hospitalization.

    Other: Retrospective data collection

Interventions

  • OtherRetrospective data collection

    Retrospective data collection to overcome the lack of knowledge on epidemiology, clinical course including diagnostic and therapeutic approaches and prognostic factors for SARS-CoV-2-infections and their complications among nephrology and elderly patients, as well as to serve as a platform for future studies and outbreak situations.

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What researchers measure

Primary outcomes

  1. Determination of the global incidence of SARS-CoV-2 infections

    Determination of the global incidence of SARS-CoV-2 infections and the resulting effects on kidney function as well as monitoring of global and local developments over time.

    Time frame: 6 months

Secondary outcomes

  1. Determination of the incidence of acute kidney damage in the context of SARS-CoV2 infections

    Determination of the incidence of acute kidney damage in the context of SARS-CoV2 infections

    Time frame: 6 months

  2. Identification of risk groups and risk factors

    Identification of risk groups and risk factors by examining SARS-CoV-2 infections in patients with chronic kidney disease and kidney transplantation

    Time frame: 6 months

  3. Documentation of mortality rates due to SARS-CoV-2 infections

    Documentation of mortality rates in % in comparison to case controls enrolled in the same hospital

    Time frame: 6 months

  4. Documentation of additional costs due to SARS-CoV-2 infections

    Documentation of additional costs in euros in comparison to case controls enrolled in the same hospital

    Time frame: 6 months

  5. To assess increasing costs associated with SARS-CoV-2-infections

    To assess increasing costs associated with SARS-CoV-2-infections

    Time frame: 6 months

  6. To analyze the effect of SARS-CoV-2-infections on the kidney by means of eGFR

    To analyze the effect of SARS-CoV-2 infections on kidney function as determined by estimated Glomerular Filtration Rate (eGFR) after SARS-CoV-2 infection

    Time frame: 6 months

  7. To analyze the effect of SARS-CoV-2-infections on the kidney by means of maximum creatinine

    To analyze the effect of SARS-CoV-2 infections on kidney function as determined by maximum creatinine after SARS-CoV-2 infection

    Time frame: 6 months

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Study locations

1 site
  • University Hospital of Cologne
    Cologne, 50937, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04797091
Lead sponsor
University of Cologne
Responsible party
Volker Burst (Principal Investigator, University of Cologne) — Principal investigator
First posted
Mar 15, 2021
Start date
Apr 20, 2020
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025
Last update
Dec 17, 2025

Study contacts

Volker Burst, PD MD
principal investigator · University Hospital of Cologne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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