Kidney Injury Severity and COVID-19

NCT04386564 | Completed

• 1 other identifier: Sechenov-COVID19_AKI
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

The authors hypothesize that the SARS-CoV-2 virus can affect the kidneys, causing them to be damaged. The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

Conditions

COVID-19; Kidney Injury

Keywords

Coronavirus Infection; Kidney Function

Outcome Measures

Primary Outcomes (1)

• The effect of COVID-19 severity on the severity of renal failure

  estimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19

  2 months

Secondary Outcomes (5)

• The expression of viral RNA in the urine with the severity of renal failure

  2 months

• The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure

  2 months

• Assessment of the severity of renal impairment in patients who died from COVID-19

  2 months

• Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19

  2 months

• Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19

  2 months

Study Arms (3)

Mild COVID-19

Pneumonia without respiratory failure

Diagnostic Test: mRNA in urine test

Moderate COVID-19 up to 60 years

Respiratory frequency ≥30/minute, blood oxygen saturation≤93%

Diagnostic Test: mRNA in urine test

Moderate COVID-19 over 60 years old and severe COVID-19

Pneumonia with respiratory distress syndrome

Diagnostic Test: mRNA in urine test

Interventions

mRNA in urine test DIAGNOSTIC_TEST

Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed

Also known as: chest and abdominal CT scan, CRP, Hb, Presepsin, eGFR, Ccr, UACR, UMA, Proteinuria

Mild COVID-19; Moderate COVID-19 over 60 years old and severe COVID-19; Moderate COVID-19 up to 60 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females with confirmed viral pneumonia

You may qualify if:

• Pneumonia confirmed by CT scans

You may not qualify if:

• a history of chronic renal failure;
• a history of kidney transplantation;
• patients with a single kidney;
• refusal of the patient to participate in the study;
• absence of SARS-CoV-2 virus smear from the nasopharynx in PCR.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov University.

Moscow, 119991, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood,urine, sputum. Renal tissue only from post-portem kidney biopsies.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Dmitry Enikeev, M.D., Ph.D.

  Sechenov University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Research

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 13, 2020
• Study Start: May 15, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)