Kidney Injury Severity and COVID-19

COVID-19 Clinical Trial

Official title:

Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386564
• Other study ID #: Sechenov-COVID19_AKI
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: February 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Kidney Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• mRNA in urine test
Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed

Locations

Country	Name	City	State
Russian Federation	Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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