Kidney in Coronavirus Disease 2019 Registry

NCT04797091 | Completed

• 1 other identifier: Kidney in COVID-19
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection; SARS-CoV 2

Outcome Measures

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.

  6 months

Secondary Outcomes (7)

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

  6 months

• Identification of risk groups and risk factors

  6 months

• Documentation of mortality rates due to SARS-CoV-2 infections

  6 months

• Documentation of additional costs due to SARS-CoV-2 infections

  6 months

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

  6 months

Study Arms (2)

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

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.

Control group; Patients with SARS-CoV-2-infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Volker Burst, PD MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: March 15, 2021
• Study Start: April 20, 2020
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)