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Kidney in Coronavirus Disease 2019 Registry (KidneyCOVID19)

23. Mai 2022 aktualisiert von: Volker Burst, University of Cologne

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.

Studienübersicht

Status

Rekrutierung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

500

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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).

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Fallkontrolle
  • Zeitperspektiven: Retrospektive

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Patients with SARS-CoV-2-infection
Patients with evidence of SARS-CoV-2-infection
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
Controls will be identified retrospectively at the same hospitals that based on matching of demographics, underlying diseases and duration of hospitalization.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Determination of the global incidence of SARS-CoV-2 infections
Zeitfenster: 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.
6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Determination of the incidence of acute kidney damage in the context of SARS-CoV2 infections
Zeitfenster: 6 months
Determination of the incidence of acute kidney damage in the context of SARS-CoV2 infections
6 months
Identification of risk groups and risk factors
Zeitfenster: 6 months
Identification of risk groups and risk factors by examining SARS-CoV-2 infections in patients with chronic kidney disease and kidney transplantation
6 months
Documentation of mortality rates due to SARS-CoV-2 infections
Zeitfenster: 6 months
Documentation of mortality rates in % in comparison to case controls enrolled in the same hospital
6 months
Documentation of additional costs due to SARS-CoV-2 infections
Zeitfenster: 6 months
Documentation of additional costs in euros in comparison to case controls enrolled in the same hospital
6 months
To assess increasing costs associated with SARS-CoV-2-infections
Zeitfenster: 6 months
To assess increasing costs associated with SARS-CoV-2-infections
6 months
To analyze the effect of SARS-CoV-2-infections on the kidney by means of eGFR
Zeitfenster: 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
6 months
To analyze the effect of SARS-CoV-2-infections on the kidney by means of maximum creatinine
Zeitfenster: 6 months
To analyze the effect of SARS-CoV-2 infections on kidney function as determined by maximum creatinine after SARS-CoV-2 infection
6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Volker Burst, PD MD, University Hospital of Cologne

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. April 2020

Primärer Abschluss (Voraussichtlich)

31. Dezember 2025

Studienabschluss (Voraussichtlich)

31. August 2026

Studienanmeldedaten

Zuerst eingereicht

16. April 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. März 2021

Zuerst gepostet (Tatsächlich)

15. März 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Mai 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Mai 2022

Zuletzt verifiziert

1. Mai 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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