Kidney Injury Severity and COVID-19

Completed

• Conditions: Kidney Injury; COVID-19
• Interventions: Diagnostic Test: mRNA in urine test

• Registration Number: NCT04386564
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Detailed Description

In December 2019, an outbreak of the 2019 novel coronavirus disease (COVID-19) caused by the SARS coronavirus 2 (SARS-CoV-2) occurred in Wuhan, China. It has spread rapidly to other areas in China and worldwide. The most common manifestations of COVID-19 included fever, dry cough, dyspnea, myalgia, fatigue and radiographic evidence of pneumonia. Complications (acute respiratory distress syndrome, shock, acute cardiac injury, secondary infection, and acute kidney injury) and death may occur in severe cases. Recent reports showed that extrapulmonary symptoms (intestinal symptoms in 10-20% of patients) and renal failure in some patients may be associated with the interaction of the virus with angiotensin-converting enzyme 2 (ACE-2) receptors in other organs. It was suggested that ACE-2 expression in the kidneys can be the cause of kidney injury occurring in a number of patients with SARS-CoV-2.However, ACE-2 is not the only possible cause of kidney injury - sepsis-related cytokine storm can also lead to damage of kidney parenchyma.

The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-13
• Study Start: 2020-05-15
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Pneumonia confirmed by CT scans

Exclusion Criteria

• a history of chronic renal failure;
• a history of kidney transplantation;
• intake of substances with a history of renal toxicity (no later than a month before inclusion);
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moderate COVID-19 up to 60 years	mRNA in urine test	Respiratory frequency ≥30/minute, blood oxygen saturation≤93%
Moderate COVID-19 over 60 years old and severe COVID-19	mRNA in urine test	Pneumonia with respiratory distress syndrome
Mild COVID-19	mRNA in urine test	Pneumonia without respiratory failure

Primary Outcome Measures

Name	Time	Method
The effect of COVID-19 severity on the severity of renal failure	2 months	estimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19

Secondary Outcome Measures

Name	Time	Method
Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19	2 months	expression of ACE-2 by imminohistochemistry at autopsy specimen
The expression of viral RNA in the urine with the severity of renal failure	2 months	viral RNA concentration in urine, ME/ml
Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19	2 months	Duration of viral RNA detection in urine by PCR, weeks
The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure	2 months	albumine excretion with urine, g/ml
Assessment of the severity of renal impairment in patients who died from COVID-19	2 months	estimated glomerular filtration rate (eGFR), ml/min

Trial Locations

Locations (1)

Sechenov University.; 🇷🇺 Moscow, Russian Federation