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Renal Biomarkers in AKI and COVID-19

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ClinicalTrials.gov Identifier: NCT04517630
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Santiago Avila-Rios, Instituto Nacional de Enfermedades Respiratorias

Brief 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. 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.


Condition or disease Intervention/treatment
Coronavirus Infection Covid19 SARS (Severe Acute Respiratory Syndrome) AKI Diagnostic Test: urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Acute Kidney Injury In Subjects With Severe Acute Respiratory Syndrome Due to SARS-CoV2 Infection
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Severe pneumoniae
Evaluate the progression to AKI during first 30 days of recruitment
Diagnostic Test: urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of AKI [ Time Frame: One month ]
    Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia

  2. Urinary levels of renal biomarkers and mortality [ Time Frame: 30 days ]
    Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality

  3. Urinary levels of renal biomarkers and severity of the disease. [ Time Frame: 30 days ]
    Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with teh severity of the disease.

  4. Risk factors for AKI in severe COVID-19 [ Time Frame: 30 days ]
    Identify possible risk factors (epidemiological, clinical, paraclinical, use of nephrotoxic agents) for the development of AKI in critically ill patients with COVID-19 pneumonia.

  5. Evolution renal biomarkers [ Time Frame: 7 days ]
    Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.

  6. Evolution of viral load [ Time Frame: 7 days ]
    Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.

  7. Evolution of complement pathway [ Time Frame: seven days ]
    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.

  8. Metabolomic profile [ Time Frame: 7 days ]
    Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.

  9. Respiratory changes [ Time Frame: 30 days ]
    Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.


Other Outcome Measures:
  1. Nosocomial Infections [ Time Frame: 30 days ]
    Stablish the nosocomial infections in subjects with or without AKI


Biospecimen Retention:   Samples With DNA
The SARS-CoV-2 RNA will be obtained from 200 microliters of urine, by standard methods


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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): NCT04517630


Contacts
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Contact: Santiago Ávila Ríos, PhD 56667985 ext 150 santiago.avila@cieni.org.mx
Contact: Amy B. Peralta Prado, MD 56667985 ext 100 amy.peralta@cieni.org.mx

Locations
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Mexico
Centro de Investigacion en Enfermedades Infecciosas Recruiting
Mexico City, Mexico, 14060
Contact: Santiago Avila Ríos, PhD    +52 (55)56667985 ext 150    santiago.avila@cieni.org.mx   
Contact: Amy B. Peralta Prado, MD    +52 (55)56667985 ext 100    amy.peralta@cieni.org.mx   
Sponsors and Collaborators
Instituto Nacional de Enfermedades Respiratorias
Investigators
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Principal Investigator: Santiago Avila Rios, PhD Instituto Nacional de Enfermedades Respiratorias
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Responsible Party: Santiago Avila-Rios, Principal Investigator, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT04517630    
Other Study ID Numbers: C26-20
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Santiago Avila-Rios, Instituto Nacional de Enfermedades Respiratorias:
AKI
SARS
METABOLOMIC
KIDNEY BIOMARKERS
COVID-19
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases