Covid19NCT05043168
Kidney Histopathology After COVID-19 and SARS-CoV-2 Vaccination
An observational study of Covid19 and Vaccination Reaction, run by University of Giessen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Vaccination Reaction
- Type of treatment
- Vaccines
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 18 Sep 2021to 17 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Primary inpatient and outpatient care
Who may be able to join
- 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
Who cannot join
- Patient refuses participation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hesse, 35392
About this study
Official title: Kidney Histopathological Features in Patients After COVID-19 and SARS-CoV-2 Vaccination
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.
Read the detailed 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.
- Conditions
- Covid19, Vaccination Reaction
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of histopathologically confirmed glomerular and tubulointerstitial diseases
Measured: Kidney biopsy obtained during COVID-19 disease and up to 3 months after SARS-CoV-2 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start18 Sep 2021
- Primary completion31 Dec 2021
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Thorsten Wiech, MD, Principal investigator, Nephropathology Section, Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043168
- Sponsor's protocol ID
- 2021-100682-BO-ff
- Status last verified
- May 2022
- First submitted
- 10 Sep 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32402155Sharma 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.
PubMed 32660970Bomback 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.
PubMed 34182049de 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.
PubMed 36723286
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Histopathological Features in Patients After COVID-19 and SARS-CoV-2 Vaccination
- ClinicalTrials.gov ID
- NCT05043168
- Acronym / sponsor ID
- 2021-100682-BO-ff
- Conditions
- Covid19, Vaccination Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- 18 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary inpatient and outpatient care
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patient refuses participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of histopathologically confirmed glomerular and tubulointerstitial diseases
Time frame: Kidney biopsy obtained during COVID-19 disease and up to 3 months after SARS-CoV-2 vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 32402155Puelles 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.
- Background: PubMed 32660970Sharma 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.
- Background: PubMed 34182049Bomback 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.
- Derived from this study: PubMed 36723286de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Wiech, MD principal investigator
Nephropathology Section, Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Vaccination Reaction, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of histopathologically confirmed glomerular and tubulointerstitial diseases (time frame: Kidney biopsy obtained during COVID-19 disease and up to 3 months after SARS-CoV-2 vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043168, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.