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

NCT ID: NCT05043168

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-18

Study Completion Date

2022-05-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Covid19 Vaccination Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with COVID-19

Polymerase Chain Reaction-positive SARS-CoV-2 infection

No interventions assigned to this group

Patients post-SARS-CoV-2 vaccination

Onset of kidney disease potentially relatable to SARS-CoV-2 vaccination based on clinical grounds

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thorsten Wiech, MD

Role: PRINCIPAL_INVESTIGATOR

Nephropathology Section, Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Locations

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University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, Germany

Site Status

Countries

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Germany

References

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Puelles VG, Lutgehetmann M, Lindenmeyer MT, Sperhake JP, Wong MN, Allweiss L, Chilla S, Heinemann A, Wanner N, Liu S, Braun F, Lu S, Pfefferle S, Schroder 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. No abstract available.

Reference Type BACKGROUND
PMID: 32402155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32660970 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 34182049 (View on PubMed)

de Las Mercedes Noriega M, Husain-Syed F, Wulf S, Csala B, Krebs CF, Jabs WJ, Zipfel PF, Grone HJ, Wiech T; CoV-Kidney Investigators. Kidney Biopsy Findings in Patients with SARS-CoV-2 Infection or After COVID-19 Vaccination. Clin J Am Soc Nephrol. 2023 May 1;18(5):613-625. doi: 10.2215/CJN.0000000000000106. Epub 2023 Feb 1.

Reference Type DERIVED
PMID: 36723286 (View on PubMed)

Other Identifiers

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2021-100682-BO-ff

Identifier Type: -

Identifier Source: org_study_id

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