COVID-19NCT06444893
Morphofunctional, Gene, Inflammation Molecules and Oxidative Stress Analysis in Kidney Tissue of COVID-19 Patients
An observational study of COVID-19 and Kidney Injury, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
Trial summary
The involvement of the kidneys in patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the outset of the pandemic was associated with high mortality rates worldwide. This was in part due to the generation of an inflammatory process and exacerbated oxidative stress. Read more about this study
- Who is it for?
- Ages 15 to 80 years, men only
- Conditions the study is for
- COVID-19, Kidney Injury, Gene Amplification
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 30 Mar 2020to 8 Oct 2023
- 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 15 to 80 years
- Men only
- Child, Adult, Older adult
Study population: Adults >15 years old who died at the INER with a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Who may be able to join
- Not having at least one creatinine measurement.
- Family members will not accept to participate.
Who cannot join
- Specimens with sub-optimal quality for analysis.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Respiratory Diseases
Mexico City, Mexico City, 14080
About this study
Official title: Morphofunctional Analysis, Gene Expression of Inflammation Molecules and Response Mechanisms to Oxidative Stress in Kidney Tissue of Deceased Patients With COVID-19: "Ancestral Variant"
The involvement of the kidneys in patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the outset of the pandemic was associated with high mortality rates worldwide. This was in part due to the generation of an inflammatory process and exacerbated oxidative stress. The present study was initiated to investigate the relationship between morphofunctional changes and gene expression in the kidney tissue of deceased Mexican patients prior to the initiation of vaccination.
The investigator designed a single-center, prospective, cohort study, to analyze and relate the morphofunctional changes and gene expression of inflammatory and oxidative stress molecules in the kidney tissue of men who died from severe COVID-19. A total of 40 percutaneous renal biopsies from deceased patients with severe acute respiratory syndrome coronavirus 2 infection were included in the study and divided into two a groups. One group was preserved in trizol to obtain RNA and total protein, while the remaining sample was fixed in formalin to be examined by staining with hematoxylin and eosin. The histopathological analysis was conducted by an experienced pathologist. The expression of molecules was evaluated by real-time polymerase chain reaction assay (nphs2, slc9a1, cx3cl1, havcr1, slc22a17, sod2, egf, timp2, hmox1, fabp1, and so forth). The following biomarkers were analyzed: interleukin-6, Arginase-1 (Arg-1), Dipeptidyl peptidase-4 (DPP-4), GSTT1, type I gamma-glutamyltransferase (GGT1), Occludin (OCL), CYP3A4, and Claudin-8 (CL-8). Additionally, Western blot analysis was conducted on claudin-5 (CL-5), occludin, HSP70, Nuclear factor erythroid 2-related factor-2 (NRF-2), superoxide dismutase-2 (SOD-2), nicotinamide adenine dinucleotide phosphate dehydrogenase 1 (NQO1), Gamma glutamylcysteine synthase (γ-GCL), and receptor for advanced glycation end products (RAGE). The estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, with the subjects divided into two groups based on their eGFR: >60 or <60 ml/min/1.73 m². The statistical analysis was conducted using the Stata program and GraphPad software, version 10.2.3.
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis and sclerosis scores for identifying morphological changes in kidney tissue.
Morphological changes were evaluated by the fibrosis and sclerosis scores (mild, moderate and severe), using direct visualization of nephron compartments (glomerular and tubulointerstitial) of patients who died due to severe COVID-19.
Measured: From the date of postmortem kidney biopsy until the date of histopathological report, in average seven days.
The estimated glomerular filtration rate for evaluating functional changes. The estimated glomerular filtration rate for evaluating functional changes.
Functional changes were calculated using the estimated glomerular filtration rate (> 60 vs < 60 ml/min/1.73m2) of patients who died due to severe COVID-19.
Measured: From the date of arrival at the hospital until the date of death, in average one month.
Secondary outcomes (3)
Differential gene expression using polymerase chain reaction
Changes in differential gene expression in the kidney tissue of patients who died from due to severe COVID-19.
Measured: From the date of postmortem kidney biopsy until the date of measure of differential gene expression, evaluated in 72 months.
Quantity of inflammatory molecules expressed in picograms of proteins.
Changes in the quantity of inflammatory molecules in the kidney tissue of patients who died due to severe COVID-19.
Measured: From the date of postmortem kidney biopsy until the date of measure the inflammatory molecules expressed in the tissue, evaluated in 72 months.
Quantity of oxidative stress molecules expressed in picograms of proteins.
Changes in the quantity of oxidative stress molecules expressed in the kidney tissues of patients who died due to severe COVID-19.
Measured: From the date of postmortem kidney biopsy to the date of measure of oxidative stress molecules expressed in the tissue report, evaluated in 72 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start30 Mar 2020
- Primary completion31 Dec 2020
- Study completion8 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jesus Rivero, MD, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444893
- Sponsor's protocol ID
- C-5920
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphofunctional Analysis, Gene Expression of Inflammation Molecules and Response Mechanisms to Oxidative Stress in Kidney Tissue of Deceased Patients With COVID-19: "Ancestral Variant"
- ClinicalTrials.gov ID
- NCT06444893
- Acronym / sponsor ID
- C-5920
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Nacional de Enfermedades RespiratoriasOther government
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 8 Oct 2023 (actual)
- First posted
- 6 Jun 2024 (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 involvement of the kidneys in patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the outset of the pandemic was associated with high mortality rates worldwide. This was in part due to the generation of an inflammatory process and exacerbated oxidative stress. The present study was initiated to investigate the relationship between morphofunctional changes and gene expression in the kidney tissue of deceased Mexican patients prior to the initiation of vaccination.
The investigator designed a single-center, prospective, cohort study, to analyze and relate the morphofunctional changes and gene expression of inflammatory and oxidative stress molecules in the kidney tissue of men who died from severe COVID-19. A total of 40 percutaneous renal biopsies from deceased patients with severe acute respiratory syndrome coronavirus 2 infection were included in the study and divided into two a groups. One group was preserved in trizol to obtain RNA and total protein, while the remaining sample was fixed in formalin to be examined by staining with hematoxylin and eosin. The histopathological analysis was conducted by an experienced pathologist. The expression of molecules was evaluated by real-time polymerase chain reaction assay (nphs2, slc9a1, cx3cl1, havcr1, slc22a17, sod2, egf, timp2, hmox1, fabp1, and so forth). The following biomarkers were analyzed: interleukin-6, Arginase-1 (Arg-1), Dipeptidyl peptidase-4 (DPP-4), GSTT1, type I gamma-glutamyltransferase (GGT1), Occludin (OCL), CYP3A4, and Claudin-8 (CL-8). Additionally, Western blot analysis was conducted on claudin-5 (CL-5), occludin, HSP70, Nuclear factor erythroid 2-related factor-2 (NRF-2), superoxide dismutase-2 (SOD-2), nicotinamide adenine dinucleotide phosphate dehydrogenase 1 (NQO1), Gamma glutamylcysteine synthase (γ-GCL), and receptor for advanced glycation end products (RAGE). The estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, with the subjects divided into two groups based on their eGFR: >60 or <60 ml/min/1.73 m². The statistical analysis was conducted using the Stata program and GraphPad software, version 10.2.3.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 80 years
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Adults >15 years old who died at the INER with a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Key inclusion criteria (2 listed)
- Not having at least one creatinine measurement.
- Family members will not accept to participate.
Key exclusion criteria (1 listed)
- Specimens with sub-optimal quality for analysis.
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
Fibrosis and sclerosis scores for identifying morphological changes in kidney tissue.
Time frame: From the date of postmortem kidney biopsy until the date of histopathological report, in average seven days.
Morphological changes were evaluated by the fibrosis and sclerosis scores (mild, moderate and severe), using direct visualization of nephron compartments (glomerular and tubulointerstitial) of patients who died due to severe COVID-19.
The estimated glomerular filtration rate for evaluating functional changes. The estimated glomerular filtration rate for evaluating functional changes.
Time frame: From the date of arrival at the hospital until the date of death, in average one month.
Functional changes were calculated using the estimated glomerular filtration rate (> 60 vs < 60 ml/min/1.73m2) of patients who died due to severe COVID-19.
3 secondary outcomes
Differential gene expression using polymerase chain reaction
Time frame: From the date of postmortem kidney biopsy until the date of measure of differential gene expression, evaluated in 72 months.
Quantity of inflammatory molecules expressed in picograms of proteins.
Time frame: From the date of postmortem kidney biopsy until the date of measure the inflammatory molecules expressed in the tissue, evaluated in 72 months.
Quantity of oxidative stress molecules expressed in picograms of proteins.
Time frame: From the date of postmortem kidney biopsy to the date of measure of oxidative stress molecules expressed in the tissue report, evaluated in 72 months.
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 27 Jun 2024.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Kidney Injury, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
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 27 Jun 2024. 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 Mexico. 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?
Fibrosis and sclerosis scores for identifying morphological changes in kidney tissue. (time frame: From the date of postmortem kidney biopsy until the date of histopathological report, in average seven days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2024.