Clinical trial NCT04386564: Kidney Injury Severity and COVID-19
Official title: Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Kidney Injury
Keywords: Coronavirus Infection
Kidney Function
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females with confirmed viral pneumonia

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.

Eligibility 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.

Primary outcomes:
measure: The effect of COVID-19 severity on the severity of renal failure
timeFrame: 2 months
Secondary outcomes:
measure: The expression of viral RNA in the urine with the severity of renal failure
timeFrame: 2 months
measure: The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure
timeFrame: 2 months
measure: Assessment of the severity of renal impairment in patients who died from COVID-19
timeFrame: 2 months
measure: Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19
timeFrame: 2 months
measure: Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19
timeFrame: 2 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University.
Study officials:
affiliation: Sechenov University
name: Dmitry Enikeev, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: