Clinical trial NCT04517630: Renal Biomarkers in AKI and COVID-19
Official title: Acute Kidney Injury In Subjects With Severe Acute Respiratory Syndrome Due to SARS-CoV2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Covid19
SARS (Severe Acute Respiratory Syndrome)
AKI
Keywords: AKI
SARS
METABOLOMIC
KIDNEY BIOMARKERS
COVID-19
Lead sponsor: Instituto Nacional de Enfermedades Respiratorias
Sponsor class: OTHER_GOV
First posted: 2020-08-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility 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

Primary outcomes:
measure: Urinary levels of renal biomarkers
timeFrame: Seven days
Secondary outcomes:
measure: Incidence of AKI
timeFrame: One month
measure: Urinary levels of renal biomarkers and mortality
timeFrame: 30 days
measure: Urinary levels of renal biomarkers and severity of the disease.
timeFrame: 30 days
measure: Risk factors for AKI in severe COVID-19
timeFrame: 30 days
measure: Evolution renal biomarkers
timeFrame: 7 days
measure: Evolution of viral load
timeFrame: 7 days
measure: Evolution of complement pathway
timeFrame: seven days
measure: Metabolomic profile
timeFrame: 7 days
measure: Respiratory changes
timeFrame: 30 days
Other outcomes:
measure: Nosocomial Infections
timeFrame: 30 days
Locations:
city: Mexico City
country: Mexico
facility: Centro de Investigacion en Enfermedades Infecciosas
Study officials:
affiliation: Instituto Nacional de Enfermedades Respiratorias
name: Santiago Avila Rios, PhD
role: PRINCIPAL_INVESTIGATOR
References: