Kidney Injury Severity and COVID-19

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19, Kidney Injury

Intervention / Treatment
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* Diagnostic Test: mRNA in urine test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild COVID-19<br>Pneumonia without respiratory failure | Diagnostic Test: mRNA in urine test<br>* Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed<br>* Other names: Proteinuria;|
| Moderate COVID-19 up to 60 years<br>Respiratory frequency ≥30/minute, blood oxygen saturation≤93% | Diagnostic Test: mRNA in urine test<br>* Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed<br>* Other names: Proteinuria;|
| Moderate COVID-19 over 60 years old and severe COVID-19<br>Pneumonia with respiratory distress syndrome | Diagnostic Test: mRNA in urine test<br>* Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed<br>* Other names: Proteinuria;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The expression of viral RNA in the urine with the severity of renal failure | viral RNA concentration in urine, ME/ml | 2 months | 
| The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure | albumine excretion with urine, g/ml | 2 months | 
| Assessment of the severity of renal impairment in patients who died from COVID-19 | estimated glomerular filtration rate (eGFR), ml/min | 2 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus Infection, Kidney Function