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

NCT05043168 | Completed

• 1 other identifier: 2021-100682-BO-ff
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Vaccination Reaction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with COVID-19

Polymerase Chain Reaction-positive SARS-CoV-2 infection

Patients post-SARS-CoV-2 vaccination

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary inpatient and outpatient care

You may qualify if:

• 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

You may not qualify if:

• Patient refuses participation

Sponsors & Collaborators

• University of Giessen: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

Location

Related Publications (4)

• 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.

  PMID: 32402155 BACKGROUND

• 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.

  PMID: 32660970 BACKGROUND

• 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.

  PMID: 34182049 BACKGROUND

• 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.

  PMID: 36723286 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Kidney biopsy

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thorsten Wiech, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 14, 2021
• Study Start: September 18, 2021
• Primary Completion: December 31, 2021
• Study Completion: May 17, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

DE (1)