Kidney Injury Severity and COVID-19

NCT ID: NCT04386564

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-09-01

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.

Conditions

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COVID-19 Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild COVID-19

Pneumonia without respiratory failure

mRNA in urine test

Intervention Type DIAGNOSTIC_TEST

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

Moderate COVID-19 up to 60 years

Respiratory frequency ≥30/minute, blood oxygen saturation≤93%

mRNA in urine test

Intervention Type DIAGNOSTIC_TEST

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

Moderate COVID-19 over 60 years old and severe COVID-19

Pneumonia with respiratory distress syndrome

mRNA in urine test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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mRNA in urine test

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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chest and abdominal CT scan CRP Hb Presepsin eGFR Ccr UACR UMA Proteinuria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dmitry Enikeev, MD, PhD

Deputy Director for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dmitry Enikeev, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sechenov University

Locations

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Sechenov University.

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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Sechenov-COVID19_AKI

Identifier Type: -

Identifier Source: org_study_id

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