Coronavirus InfectionNCT04517630
Renal Biomarkers in AKI and COVID-19
An observational study of Coronavirus Infection and Covid19, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
Trial summary
Severe pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronavirus Infection, Covid19, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic
- How many people
- 51 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2020to 30 Sep 2021
- How long will I take part?
- 60 Days
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Older adults were recruited, with a diagnosis of COVID-19 confirmed by PCR, in their first 48 hours of hospitalization that meet severity criteria, with 5 to 7 degrees of severity according to the WHO classification.
Who may be able to join
- Subjects over 18 years of age.
- Subjects admitted with a diagnosis of probable SARS-CoV-2 pneumonia.
- Subjects with a diagnosis of SARS-CoV-2 pneumonia confirmed by Real-time quantitative-Polymerase Chain Reaction (qRT-PCR).
- Subjects with qRT-PCR negative for SARS-CoV-2, but who meet clinical and radiological criteria for COVID-19, and no other causes have been identified.
Who cannot join
- Pregnant women
- Incomplete medical records.
- Elimination criteria:
- Patients who die within the first 24 hours of entering the institute.
- Patients discharged for any reason not considered death within the first 48 hours, such as voluntary discharge or transfer to other health institutions.
- Patients who during their hospitalization report a positive PCR for other non-respiratory viruses without identifying SARS-CoV-2
- Patients who withdraw their consent
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Investigacion en Enfermedades Infecciosas
Mexico City, 14060
About this study
Official title: Acute Kidney Injury In Subjects With Severe Acute Respiratory Syndrome Due to SARS-CoV2 Infection
Severe pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. We need many studies for determinated the risk factors for AKI in subjects with COVID-19.
This study pretends identify the incidence of AKI in subjects with severe pneumoniae by COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and determine the evolution of urinary biomarkers during hospitalization, like neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2 (CoV2) in subjects with or without AKI.
Read the detailed description
The usefulness of urinary NGAL levels and the platelet / lymphocyte index as predictive markers of AKI in the context of COVID-19 will be studied. These results will allow to propose more appropriate strategies for the prevention, diagnosis and timely management of patients with severe pneumonia due to COVID-19 and AKI. Knowing the viral load in urine and its evolution in patients with and without AKI will allow us to explore associations between the presence of the virus at the local level and the presence of kidney damage. Likewise, the presence of viral load in urine and its possible relationship with the local activation of the complement system, together with the detection of biomarkers of kidney damage, like NGAL, TIMP-2, IGFBP7, and IL-6, will allow us to better understand the pathophysiology of these alterations in the context of COVID-19; additionally, some patients received tocilizumab, an IL-6 inhibitor as a compassionate measure, which may reduce urinary levels of interleukins and other inflammatory markers.
Finally, the study of possible differences in the metabolome in urine in patients with and without acute kidney injury could favor the discovery of new markers to identify patients with SARS-CoV-2 infection susceptible to the development of AKI.
Determine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic basal, and the days 3 , 5 and 7 after recruitment
- Being tested
- urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic
- Keywords
- AKI, SARS, METABOLOMIC, KIDNEY BIOMARKERS, COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomicDiagnostic test
Determine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic at basal, and the 3 , 5 and 7 days after recruitment
| Study group | Role | What they receive |
|---|---|---|
| Severe pneumoniae | Evaluate the progression to AKI during first 30 days of recruitment Receives: Diagnostic Test: urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary levels of renal biomarkers
To estimate the strength of association between the elevation of urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 and the development of AKI associated with SARS-CoV-2 pneumonia
Measured: Seven days
Secondary outcomes (9)
Incidence of AKI
Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia
Measured: One month
Urinary levels of renal biomarkers and mortality
Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality
Measured: 30 days
Urinary levels of renal biomarkers and severity of the disease.
Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with teh severity of the disease.
Measured: 30 days
Risk factors for AKI in severe COVID-19
Identify possible risk factors (epidemiological, clinical, paraclinical, use of nephrotoxic agents) for the development of AKI in critically ill patients with COVID-19 pneumonia.
Measured: 30 days
Evolution renal biomarkers
Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.
Measured: 7 days
Evolution of viral load
Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.
Measured: 7 days
Evolution of complement pathway
Analyze the complement pathway in urine and compare its evolution over time in patients with and without acute kidney injury and SARS-CoV-2 infection.
Measured: seven days
Metabolomic profile
Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.
Measured: 7 days
Respiratory changes
Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- 51 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Santiago Avila-Rios, Instituto Nacional de Enfermedades Respiratorias
- Investigators
- Santiago Avila Rios, PhD, Principal investigator, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517630
- Sponsor's protocol ID
- C26-20
- Status last verified
- Jun 2024
- First submitted
- 15 Aug 2020
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury In Subjects With Severe Acute Respiratory Syndrome Due to SARS-CoV2 Infection
- ClinicalTrials.gov ID
- NCT04517630
- Acronym / sponsor ID
- C26-20
- Keywords
- AKI, SARS, METABOLOMIC, KIDNEY BIOMARKERS, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Instituto Nacional de Enfermedades RespiratoriasOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 18 Aug 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.
Severe pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. We need many studies for determinated the risk factors for AKI in subjects with COVID-19.
This study pretends identify the incidence of AKI in subjects with severe pneumoniae by COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and determine the evolution of urinary biomarkers during hospitalization, like neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2 (CoV2) in subjects with or without AKI.
Detailed description
The usefulness of urinary NGAL levels and the platelet / lymphocyte index as predictive markers of AKI in the context of COVID-19 will be studied. These results will allow to propose more appropriate strategies for the prevention, diagnosis and timely management of patients with severe pneumonia due to COVID-19 and AKI. Knowing the viral load in urine and its evolution in patients with and without AKI will allow us to explore associations between the presence of the virus at the local level and the presence of kidney damage. Likewise, the presence of viral load in urine and its possible relationship with the local activation of the complement system, together with the detection of biomarkers of kidney damage, like NGAL, TIMP-2, IGFBP7, and IL-6, will allow us to better understand the pathophysiology of these alterations in the context of COVID-19; additionally, some patients received tocilizumab, an IL-6 inhibitor as a compassionate measure, which may reduce urinary levels of interleukins and other inflammatory markers.
Finally, the study of possible differences in the metabolome in urine in patients with and without acute kidney injury could favor the discovery of new markers to identify patients with SARS-CoV-2 infection susceptible to the development of AKI.
Determine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic basal, and the days 3 , 5 and 7 after recruitment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe pneumoniae | – | Diagnostic Test: urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomicEvaluate the progression to AKI during first 30 days of recruitment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults were recruited, with a diagnosis of COVID-19 confirmed by PCR, in their first 48 hours of hospitalization that meet severity criteria, with 5 to 7 degrees of severity according to the WHO classification.
Key inclusion criteria (4 listed)
- Subjects over 18 years of age.
- Subjects admitted with a diagnosis of probable SARS-CoV-2 pneumonia.
- Subjects with a diagnosis of SARS-CoV-2 pneumonia confirmed by Real-time quantitative-Polymerase Chain Reaction (qRT-PCR).
- Subjects with qRT-PCR negative for SARS-CoV-2, but who meet clinical and radiological criteria for COVID-19, and no other causes have been identified.
Key exclusion criteria (7 listed)
- Pregnant women
- Incomplete medical records.
- Patients who die within the first 24 hours of entering the institute.
- Patients discharged for any reason not considered death within the first 48 hours, such as voluntary discharge or transfer to other health institutions.
- Patients who during their hospitalization report a positive PCR for other non-respiratory viruses without identifying SARS-CoV-2
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 |
|---|---|---|
| urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomicDetermine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic at basal, and the 3 , 5 and 7 days after recruitment | Diagnostic test | Severe pneumoniae |
Primary outcome
Urinary levels of renal biomarkers
Time frame: Seven days
To estimate the strength of association between the elevation of urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 and the development of AKI associated with SARS-CoV-2 pneumonia
9 secondary outcomes
Incidence of AKI
Time frame: One month
Urinary levels of renal biomarkers and mortality
Time frame: 30 days
Urinary levels of renal biomarkers and severity of the disease.
Time frame: 30 days
Risk factors for AKI in severe COVID-19
Time frame: 30 days
Evolution renal biomarkers
Time frame: 7 days
Evolution of viral load
Time frame: 7 days
Evolution of complement pathway
Time frame: seven days
Metabolomic profile
Time frame: 7 days
Respiratory changes
Time frame: 30 days
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 6 Jun 2024.
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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.
Santiago Avila Rios, PhD principal investigator
Instituto Nacional de Enfermedades Respiratorias
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 Coronavirus Infection and Covid19, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
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 4 inclusion and 7 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 6 Jun 2024. 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 Mexico. 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?
Urinary levels of renal biomarkers (time frame: Seven days). 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 6 Jun 2024.