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Completed

NCT Number: NCT04386564

Kidney Injury Severity and COVID-19

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sechenov University.

Moscow, 119991, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mRNA in urine test

Diagnostic Test

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

Other names: chest and abdominal CT scan, CRP, Hb, Presepsin, eGFR, Ccr, UACR, UMA, Proteinuria

Primary outcomes

  1. The effect of COVID-19 severity on the severity of renal failure

    Time frame: 2 months

    estimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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