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Completed

NCT Number: NCT04797091

Kidney in Coronavirus Disease 2019 Registry

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne

Cologne, 50937, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Retrospective data collection

Other

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.

Primary outcomes

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

    Time frame: 6 months

    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.

Secondary outcomes

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

    Time frame: 6 months

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

  2. Identification of risk groups and risk factors

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

    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

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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: KidneyCOVID19

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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