Kidney Injury Severity and COVID-19
Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Moscow, Russian Federation, 119991
- Sechenov University.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Mild COVID-19
Pneumonia without respiratory failure
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Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed
Other Names:
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Moderate COVID-19 up to 60 years
Respiratory frequency ≥30/minute, blood oxygen saturation≤93%
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Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed
Other Names:
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Moderate COVID-19 over 60 years old and severe COVID-19
Pneumonia with respiratory distress syndrome
|
Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The effect of COVID-19 severity on the severity of renal failure
Time Frame: 2 months
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estimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19
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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
Time Frame: 2 months
|
viral RNA concentration in urine, ME/ml
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2 months
|
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The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure
Time Frame: 2 months
|
albumine excretion with urine, g/ml
|
2 months
|
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Assessment of the severity of renal impairment in patients who died from COVID-19
Time Frame: 2 months
|
estimated glomerular filtration rate (eGFR), ml/min
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2 months
|
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Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19
Time Frame: 2 months
|
Duration of viral RNA detection in urine by PCR, weeks
|
2 months
|
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Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19
Time Frame: 2 months
|
expression of ACE-2 by imminohistochemistry at autopsy specimen
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2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sechenov-COVID19_AKI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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