Association of the Neutrophil/Lymphocyte Ratio With Clinical Complications and Mortality in COVID-19 Patients

NCT04434157 | Completed DMC

• 1 other identifier: NR-09-2020
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

There is little information about the clinical characteristics and risk factors of Covid-19 in Latin American countries considering the ethnic differences and the high prevalence of obesity and cardiometabolic diseases. The aim of the study was to evaluate the association between laboratory tests and the risk of complications in SARS-CoV-2 infection and to determine their mortality risk factors in a sample of the Mexican population. A retrospective cross-sectional study of the routinely collected data was performed in the Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI), State of Mexico. Adult patients (aged ≥18 years) with positive RT-PCR for SARS-CoV-2 and oxygen support that were admitted between March 28 and May 5, 2020, were included

Conditions

Covid-19

Keywords

Clinical Complications; Mortality Risk; COVID-19; Neutrophil/Lymphocyte Ratio

Outcome Measures

Primary Outcomes (2)

• Clinical complications and Mortality

  To main aim of the study is to evaluate clinical complicatios and mortality in mexican Covid-19 patients

  10 days

• Neutrophil-Lymphocyte and Lymphocyte-Platelet ratio

  To evaluate the association of the hematological ratios with the clinical complicatios and mortality in covid-19 patinets

  10 days

Other Outcomes (2)

• Hematic and biochemical parameters

  10 days

• Chronic diseases

  10 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all hospitalized patients with the diagnosis of COVID-19 in the Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI) that were admitted in the Emergency ward, Intensive Care Unit (ICU) and all the reconversion areas.

You may qualify if:

• Adult patients (aged ≥18 years)
• Clinical (Positive RT-PCR for SARS-CoV-2 test) and radiological diagnosis of pulmonary infection by COVID-19
• Diagnosis of acute respiratory distress syndrome clinical panel in accordance with Berlin 2012 criteria
• Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)

You may not qualify if:

• Previous diagnosis of severe liver or kidney failure.
• Patients with Human Immunodeficiency Virus (HIV) infection.
• Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts.
• Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes.
• Patients with a diagnosis of active or non-active cancer.
• Absence of a clinical record for monitoring the data.
• Pregnancy.
• Patients referred from other institutions for their medical care. Clinical records of patients who requested their voluntary discharge Clinical records that do not include information of the course of COVID-19 infection

Sponsors & Collaborators

• Hospital Regional de Alta especialidad de Ixtapaluca: lead
• Hospital General de México Dr. Eduardo Liceaga: collaborator

Study Sites (1)

Hospital Regional de Alta Especialidad de Ixtapaluca

Ixtapaluca, State of Mexico, 56530, Mexico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christian Ramos Peñafiel, MD, PhD

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: March 28, 2020
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)