COVID-19NCT04386564
Kidney Injury Severity and COVID-19
An observational study of COVID-19 and Kidney Injury, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Kidney Injury
- What is being tested?
- mRNA in urine test
- How many people
- 340 participants
- Where
- 1 siteRussia
- Study dates
- 15 May 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females with confirmed viral pneumonia
Who may be able to join
- Pneumonia confirmed by CT scans
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of 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.
Read the 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.
- Conditions
- COVID-19, Kidney Injury
- Being tested
- mRNA in urine test
- Keywords
- Coronavirus Infection, Kidney Function
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA in urine testDiagnostic test
Also called chest and abdominal CT scan, CRP, Hb, Presepsin
Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed
| Study group | Role | What they receive |
|---|---|---|
| Mild COVID-19 | Pneumonia without respiratory failure Receives: Diagnostic Test: mRNA in urine test | |
| Moderate COVID-19 up to 60 years | Respiratory frequency ≥30/minute, blood oxygen saturation≤93% Receives: Diagnostic Test: mRNA in urine test | |
| Moderate COVID-19 over 60 years old and severe COVID-19 | Pneumonia with respiratory distress syndrome Receives: Diagnostic Test: mRNA in urine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of COVID-19 severity on the severity of renal failure
estimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19
Measured: 2 months
Secondary outcomes (5)
The expression of viral RNA in the urine with the severity of renal failure
viral RNA concentration in urine, ME/ml
Measured: 2 months
The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure
albumine excretion with urine, g/ml
Measured: 2 months
Assessment of the severity of renal impairment in patients who died from COVID-19
estimated glomerular filtration rate (eGFR), ml/min
Measured: 2 months
Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19
Duration of viral RNA detection in urine by PCR, weeks
Measured: 2 months
Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19
expression of ACE-2 by imminohistochemistry at autopsy specimen
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start15 May 2020
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
- Investigators
- Dmitry Enikeev, M.D., Ph.D., Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386564
- Sponsor's protocol ID
- Sechenov-COVID19_AKI
- Status last verified
- Feb 2021
- First submitted
- 11 May 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19
- ClinicalTrials.gov ID
- NCT04386564
- Acronym / sponsor ID
- Sechenov-COVID19_AKI
- Conditions
- COVID-19, Kidney Injury
- Keywords
- Coronavirus Infection, Kidney Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild COVID-19 | – | Diagnostic Test: mRNA in urine testPneumonia without respiratory failure |
| Moderate COVID-19 up to 60 years | – | Diagnostic Test: mRNA in urine testRespiratory frequency ≥30/minute, blood oxygen saturation≤93% |
| Moderate COVID-19 over 60 years old and severe COVID-19 | – | Diagnostic Test: mRNA in urine testPneumonia with respiratory distress syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females with confirmed viral pneumonia
Key inclusion criteria (1 listed)
- Pneumonia confirmed by CT scans
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA in urine testAlso: chest and abdominal CT scan, CRP, Hb, PresepsinAssessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed | Diagnostic test | Mild COVID-19, Moderate COVID-19 over 60 years old and severe COVID-19, Moderate COVID-19 up to 60 years |
Primary outcome
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
5 secondary outcomes
The expression of viral RNA in the urine with the severity of renal failure
Time frame: 2 months
The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure
Time frame: 2 months
Assessment of the severity of renal impairment in patients who died from COVID-19
Time frame: 2 months
Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19
Time frame: 2 months
Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Enikeev, M.D., Ph.D. principal investigator
Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Kidney Injury, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of COVID-19 severity on the severity of renal failure (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.