Corona Virus InfectionKidneyCOVID19NCT04797091
Kidney in Coronavirus Disease 2019 Registry
An observational study of Corona Virus Infection and SARS-CoV 2, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corona Virus Infection, SARS-CoV 2
- What is being tested?
- Retrospective data collection
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 20 Apr 2020to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Virology evidence of SARS-CoV-2-infection
- Pathological evidence of SARS-CoV-2-infection
Who cannot join
- Occurrence of ARDS (acute respiratory distress syndrome) without evidence of SARS-CoV-2 infection
- Acute kidney injury without evidence of SARS-CoV-2 infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Corona Virus Infection, SARS-CoV 2
- Being tested
- Retrospective data collection
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with SARS-CoV-2-infection | Patients with evidence of SARS-CoV-2-infection Receives: 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. Receives: Other: Retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
To assess increasing costs associated with SARS-CoV-2-infections
To assess increasing costs associated with SARS-CoV-2-infections
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start20 Apr 2020
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, PD MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797091
- Sponsor's protocol ID
- Kidney in COVID-19
- Acronym
- KidneyCOVID19
- Status last verified
- Dec 2025
- First submitted
- 16 Apr 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney in Coronavirus Disease 2019 Registry
- ClinicalTrials.gov ID
- NCT04797091
- Acronym / sponsor ID
- KidneyCOVID19 / Kidney in COVID-19
- Conditions
- Corona Virus Infection, SARS-CoV 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with SARS-CoV-2-infection | – | Other: Retrospective data collectionPatients with evidence of SARS-CoV-2-infection |
| Control group | – | Other: Retrospective data collectionControls will be identified retrospectively at the same hospitals that based on matching of demographics, underlying diseases and duration of hospitalization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Virology evidence of SARS-CoV-2-infection
- Pathological evidence of SARS-CoV-2-infection
Key exclusion criteria (2 listed)
- Occurrence of ARDS (acute respiratory distress syndrome) without evidence of SARS-CoV-2 infection
- Acute kidney injury without evidence of SARS-CoV-2 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective data collectionRetrospective 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. | Other | Control group, Patients with SARS-CoV-2-infection |
Primary outcome
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.
7 secondary outcomes
Determination of the incidence of acute kidney damage in the context of SARS-CoV2 infections
Time frame: 6 months
Identification of risk groups and risk factors
Time frame: 6 months
Documentation of mortality rates due to SARS-CoV-2 infections
Time frame: 6 months
Documentation of additional costs due to SARS-CoV-2 infections
Time frame: 6 months
To assess increasing costs associated with SARS-CoV-2-infections
Time frame: 6 months
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 the kidney by means of maximum creatinine
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Burst, PD MD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and SARS-CoV 2, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the global incidence of SARS-CoV-2 infections (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.