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Kidney Injury Severity and COVID-19

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04386564
Enrollment
340
Registered
2020-05-13
Start date
2020-05-15
Completion date
2020-09-01
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Kidney Injury

Keywords

Coronavirus Infection, Kidney Function

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.

Interventions

DIAGNOSTIC_TESTmRNA in urine test

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

Sponsors

I.M. Sechenov First Moscow State Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The effect of COVID-19 severity on the severity of renal failure2 monthsestimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19

Secondary

MeasureTime frameDescription
The expression of viral RNA in the urine with the severity of renal failure2 monthsviral RNA concentration in urine, ME/ml
The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure2 monthsalbumine excretion with urine, g/ml
Assessment of the severity of renal impairment in patients who died from COVID-192 monthsestimated glomerular filtration rate (eGFR), ml/min
Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-192 monthsDuration of viral RNA detection in urine by PCR, weeks
Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-192 monthsexpression of ACE-2 by imminohistochemistry at autopsy specimen

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026