Clinical trial NCT04797091: Kidney in Coronavirus Disease 2019 Registry
Official title: Kidney in Coronavirus Disease 2019 Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corona Virus Infection
SARS-CoV 2
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of the global incidence of SARS-CoV-2 infections
timeFrame: 6 months
Secondary outcomes:
measure: Determination of the incidence of acute kidney damage in the context of SARS-CoV2 infections
timeFrame: 6 months
measure: Identification of risk groups and risk factors
timeFrame: 6 months
measure: Documentation of mortality rates due to SARS-CoV-2 infections
timeFrame: 6 months
measure: Documentation of additional costs due to SARS-CoV-2 infections
timeFrame: 6 months
measure: To assess increasing costs associated with SARS-CoV-2-infections
timeFrame: 6 months
measure: To analyze the effect of SARS-CoV-2-infections on the kidney by means of eGFR
timeFrame: 6 months
measure: To analyze the effect of SARS-CoV-2-infections on the kidney by means of maximum creatinine
timeFrame: 6 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: University Hospital of Cologne
name: Volker Burst, PD MD
role: PRINCIPAL_INVESTIGATOR
References: