Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Kidney Injury Severity and COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386564
Recruitment Status : Active, not recruiting
First Posted : May 13, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University

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.

Condition or disease Intervention/treatment
COVID-19 Kidney Injury Diagnostic Test: mRNA in urine test

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mild COVID-19
Pneumonia without respiratory failure
Diagnostic Test: mRNA in urine 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

Moderate COVID-19 up to 60 years
Respiratory frequency ≥30/minute, blood oxygen saturation≤93%
Diagnostic Test: mRNA in urine 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

Moderate COVID-19 over 60 years old and severe COVID-19
Pneumonia with respiratory distress syndrome
Diagnostic Test: mRNA in urine 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 Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood,urine, sputum. Renal tissue only from post-portem kidney biopsies.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females with confirmed viral pneumonia
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386564


Locations
Layout table for location information
Russian Federation
Sechenov University.
Moscow, Russian Federation, 119991
Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University
Investigators
Layout table for investigator information
Principal Investigator: Dmitry Enikeev, M.D., Ph.D. Sechenov University
Layout table for additonal information
Responsible Party: Dmitry Enikeev, MD, PhD, Deputy Director for Research, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT04386564    
Other Study ID Numbers: Sechenov-COVID19_AKI
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University:
Coronavirus Infection
Kidney Function
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries