Renal Biomarkers in AKI and COVID-19

NCT04517630 | Completed

• 1 other identifier: C26-20
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Covid19; SARS (Severe Acute Respiratory Syndrome); AKI

Keywords

AKI; SARS; METABOLOMIC; KIDNEY BIOMARKERS; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  Seven days

Secondary Outcomes (9)

• Incidence of AKI

  One month

• Urinary levels of renal biomarkers and mortality

  30 days

• Urinary levels of renal biomarkers and severity of the disease.

  30 days

• Risk factors for AKI in severe COVID-19

  30 days

• Evolution renal biomarkers

  7 days

Other Outcomes (1)

• Nosocomial Infections

  30 days

Study Arms (1)

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

Interventions

urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic DIAGNOSTIC_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

Severe pneumoniae

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead

Study Sites (1)

Centro de Investigacion en Enfermedades Infecciosas

Mexico City, 14060, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

The SARS-CoV-2 RNA will be obtained from 200 microliters of urine, by standard methods

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Severe Acute Respiratory Syndrome

Interventions

Viral Load

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Virus Physiological Phenomena; Microbiological Phenomena

Study Officials

• Santiago Avila Rios, PhD

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 18, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2021
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

ME (1)