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

Sponsor
Hospital Regional de Alta especialidad de Ixtapaluca (Other)
Overall Status
Completed
CT.gov ID
NCT04434157
Collaborator
Hospital General de México Dr. Eduardo Liceaga (Other)
221
1
1.2
177

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Data collection Data was collected deidentified admission from adult patients, with oxygen therapy. Data were extracted from clinical medical records and the electronic database of daily laboratory test results. Also, incomplete clinical records were included. The number of cases in the area during the study period determined the sample size, no formal hypotheses being implemented. All patients who met the inclusion criteria were included.

    Study variables Demographic variables (sex and age), chronic medical histories (hypertension, diabetes and cancer), laboratory plasma, and serum-based biomarkers, as well as the mortality, mechanical ventilation, and length of stay, were considered. Leukocytosis was considered as a leucocyte count above 10 x 103/mcL, a cut point of INL> 10, d- dimer 500 U/L, DHL> 500U/L, low count of lymphocytes < 0·5103/mcL as risk factors exposure to death and mechanical ventilation.

    A new variable was create combining the data of neutrophil count (ANC) and lymphocyte count (ALC) to obtain the neutrophil-to-lymphocyte ratio (NLR) (calculated dividing the ANC by the ALC).

    Outcomes The hypothesis was formulated before the statistical analysis. Our primary outcomes were to 1) To describe the clinical characteristics of the Mexican population with SARS-CoV-2 infection, and 2) To determine the mortality risk factors in Covid-19.

    Secondary outcomes included 1) To identify the chronic diseases related to Covid-19 in Mexican population and 2) To evaluate the differences in hematic and biochemical parameters between survivors and no survivors.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    221 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Association of the Neutrophil/Lymphocyte Ratio and Lymphocyte /Platelet Ratio With Clinical Complications and Mortality in COVID-19 Patients
    Actual Study Start Date :
    Mar 28, 2020
    Actual Primary Completion Date :
    May 5, 2020
    Actual Study Completion Date :
    May 5, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Clinical complications and Mortality [10 days]

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

    2. Neutrophil-Lymphocyte and Lymphocyte-Platelet ratio [10 days]

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

    Other Outcome Measures

    1. Hematic and biochemical parameters [10 days]

      To evaluate the differences in hematic and biochemical parameters between survivors and no survivors

    2. Chronic diseases [10 days]

      To identify the chronic diseases in the patientss´medical records associated with the pulmonary complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Adult patients (aged ≥18 years)

    2. Clinical (Positive RT-PCR for SARS-CoV-2 test) and radiological diagnosis of pulmonary infection by COVID-19

    3. Diagnosis of acute respiratory distress syndrome clinical panel in accordance with Berlin 2012 criteria

    4. Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)

    Exclusion Criteria:
    1. Previous diagnosis of severe liver or kidney failure.

    2. Patients with Human Immunodeficiency Virus (HIV) infection.

    3. Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts.

    4. Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes.

    5. Patients with a diagnosis of active or non-active cancer.

    6. Absence of a clinical record for monitoring the data.

    7. Pregnancy.

    8. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Regional de Alta Especialidad de Ixtapaluca Ixtapaluca State Of Mexico Mexico 56530

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omar Ramos-Peñafiel, Christian Ramos Peñafiel, MD, PhD, Hospital Regional de Alta especialidad de Ixtapaluca
    ClinicalTrials.gov Identifier:
    NCT04434157
    Other Study ID Numbers:
    • NR-09-2020
    First Posted:
    Jun 16, 2020
    Last Update Posted:
    Jun 16, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Omar Ramos-Peñafiel, Christian Ramos Peñafiel, MD, PhD, Hospital Regional de Alta especialidad de Ixtapaluca
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 16, 2020