- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04797091
Kidney in Coronavirus Disease 2019 Registry (KidneyCOVID19)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Felix Köhler, MD
- Telefonní číslo: +4922147897222
- E-mail: felix.koehler@uk-koeln.de
Studijní záloha kontaktů
- Jméno: Victor Suarez, MD
- Telefonní číslo: +4922147897222
- E-mail: victor.suarez@uk-koeln.de
Studijní místa
-
-
-
Cologne, Německo, 50937
- Nábor
- University Hospital of Cologne
-
Kontakt:
- Volker Burst, MD
- Telefonní číslo: +49(0)221 478 86285
- E-mail: volker.burst@uk-koeln.de
-
Kontakt:
- Victor Suarez, MD
- E-mail: victor.suarez@uk-koeln.de
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Case-Control
- Časové perspektivy: Retrospektivní
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Determination of the global incidence of SARS-CoV-2 infections
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Determination of the incidence of acute kidney damage in the context of SARS-CoV2 infections
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Volker Burst, PD MD, University Hospital of Cologne
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Kidney in COVID-19
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na SARS-CoV-2
-
Argorna Pharmaceuticals Co., LTDDokončeno
-
Argorna Pharmaceuticals Co., LTDDokončeno
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Aktivní, ne nábor
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Aktivní, ne nábor
-
Arcturus Therapeutics, Inc.Ukončeno
-
University Hospital Inselspital, BerneUniversity of Bern; Lucerne University of Applied Sciences and ArtsDokončeno
-
Centre Hospitalier Universitaire DijonNeznámý
-
Meshalkin Research Institute of Pathology of CirculationNeznámý
-
AIM Vaccine Co., Ltd.Zhejiang Provincial Center for Disease Control and PreventionZatím nenabíráme
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Zatím nenabíráme
Klinické studie na Retrospective data collection
-
Weill Medical College of Cornell UniversityBecton, Dickinson and CompanyPozastaveno
-
IdentigeneCRI Lifetree Clinical ResearchNeznámý
-
M.D. Anderson Cancer CenterDokončenoRakovina prsuSpojené státy
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)NáborPeritoneální karcinomatóza | Novotvar trávicího systému | Karcinom jater a intrahepatálních žlučovodů | Apendix Karcinom podle AJCC V8 Stage | Kolorektální karcinom podle AJCC V8 Stage | Karcinom jícnu podle stadia AJCC V8 | Karcinom žaludku podle stadia AJCC V8Spojené státy
-
Cliniques universitaires Saint-Luc- Université...Université de LiègeNáborCystická fibróza | BiomarkeryBelgie
-
Memorial Sloan Kettering Cancer CenterDokončenoRakovina prostatySpojené státy
-
Indiana UniversityUkončenoDiabetes Mellitus | Bakteriální infekce | Rána | Infikovaný vřed kůžeSpojené státy
-
University of MinnesotaNational Institute on Drug Abuse (NIDA)DokončenoPorucha užívání látkySpojené státy
-
Hospices Civils de LyonDokončenoKardiogenní šok | Refrakterní šokFrancie