Morphofunctional Analysis and Gene Expression of Inflammation Molecules and Response Mechanisms to Oxidative Stress in Kidney Tissue of Deceased Patients With SARS-CoV-2 Virus Infection: "Ancestral Variant"

COVID-19 Clinical Trial

Official title:

Morphofunctional Analysis and Gene Expression of Inflammation Molecules and Response Mechanisms to Oxidative Stress in Kidney Tissue of Deceased Patients With SARS-CoV-2 Virus Infection: "Ancestral Variant"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06444893
• Other study ID #: C-5920
• Status: Completed
• Start date: March 30, 2020
• Est. completion date: October 8, 2023

Study information

• Verified date: June 2024
• Source: Instituto Nacional de Enfermedades Respiratorias
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The involvement of the kidneys in patients infected with the SARS-CoV-2 virus 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 SARS-CoV-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 nephropathologist. The expression of molecules was evaluated by real-time PCR (nphs2, slc9a1, cx3cl1, havcr1, slc22a17, sod2, egf, timp2, hmox1, fabp1, and so forth). The following biomarkers were analyzed: IL-6, Arg-1, DPP4, GSTT1, GGT1, OCL, CYP3A4, and CL-8. Additionally, Western blot analysis was conducted on claudins-5, occludin, HSP70, NRF-2, SOD2, NQO1, γ-GCL, and RAGE. The estimated glomerular filtration rate (eGFR) was calculated using the CKD-EPI (2021) 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 Prism software.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 8, 2023
• Est. primary completion date: December 31, 2020
• Gender: Male
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Not having at least one creatinine measurement.

• Family members will not accept to participate.

Exclusion Criteria:

• Specimens with sub-optimal quality for analysis.

Related Conditions & MeSH terms

• COVID-19
• Gene Amplification
• Inflammation
• Inflammatory Response
• Kidney Injury
• Oxidative Stress
• Virus Diseases

Locations

Country	Name	City	State
Mexico	National Institute of Respiratory Diseases	Mexico City	Ciudad DE México

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Enfermedades Respiratorias

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To analyze and relate the morphofunctional changes and gene expression of inflammatory molecules and response mechanisms to oxidative stress in the kidney tissue of patients who died from severe COVID-19.	Morphofunctional Changes	At the time of death
Secondary	Evaluate the content of proteins involved in the antioxidant response.	Content	At the time of death