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NCT05043168 Clinical Trial

Kidney Histopathology After COVID-19 and SARS-CoV-2 Vaccination

Covid19 Clinical Trial

Official title:
Kidney Histopathological Features in Patients After COVID-19 and SARS-CoV-2 Vaccination

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05043168
Other study ID # 2021-100682-BO-ff
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2021
Est. completion date May 17, 2022

Study information
Verified date May 2022
Source University of Giessen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to summarize kidney histopathological findings in patients with coronavirus disease 2019 (COVID-19) and post-severe acute respiratory syndrome-coronavirus-type 2 (SARS-CoV-2) vaccination.

Description:

The SARS-CoV-2 pandemic has had substantial global morbidity and mortality. While COVID-19 is most commonly characterized as a respiratory illness, extrapulmonary manifestations are a prominent part its clinical spectrum. Kidney disease is a common finding in COVID-19, and has also been rarely described after SARS-CoV-2 vaccination. The main objective of this study is to summarize kidney histopathological findings in patients with COVID-19 and post-SARS-COV-2 vaccination, in whom native kidney biopsy was performed and samples were obtained by the Nephropathology Section, Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date May 17, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - being diagnosed with COVID-19 when kidney biopsy was performed - history of recent homologous or heterogenous vaccine regimen comprising either vector-based vaccines or messenger ribonucleic acid-based vaccines Exclusion Criteria: - Patient refuses participation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Clinic Giessen and Marburg - Campus Giessen Giessen Hessen

Sponsors (2)
Lead Sponsor Collaborator
University of Giessen Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Bomback AS, Kudose S, D'Agati VD. De Novo and Relapsing Glomerular Diseases After COVID-19 Vaccination: What Do We Know So Far? Am J Kidney Dis. 2021 Oct;78(4):477-480. doi: 10.1053/j.ajkd.2021.06.004. Epub 2021 Jun 25. — View Citation

Puelles VG, Lütgehetmann M, Lindenmeyer MT, Sperhake JP, Wong MN, Allweiss L, Chilla S, Heinemann A, Wanner N, Liu S, Braun F, Lu S, Pfefferle S, Schröder AS, Edler C, Gross O, Glatzel M, Wichmann D, Wiech T, Kluge S, Pueschel K, Aepfelbacher M, Huber TB. Multiorgan and Renal Tropism of SARS-CoV-2. N Engl J Med. 2020 Aug 6;383(6):590-592. doi: 10.1056/NEJMc2011400. Epub 2020 May 13. — View Citation

Sharma P, Uppal NN, Wanchoo R, Shah HH, Yang Y, Parikh R, Khanin Y, Madireddy V, Larsen CP, Jhaveri KD, Bijol V; Northwell Nephrology COVID-19 Research Consortium. COVID-19-Associated Kidney Injury: A Case Series of Kidney Biopsy Findings. J Am Soc Nephrol. 2020 Sep;31(9):1948-1958. doi: 10.1681/ASN.2020050699. Epub 2020 Jul 13. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of histopathologically confirmed glomerular and tubulointerstitial diseases Kidney biopsy obtained during COVID-19 disease and up to 3 months after SARS-CoV-2 vaccination
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