<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434157</url>
  </required_header>
  <id_info>
    <org_study_id>NR-09-2020</org_study_id>
    <nct_id>NCT04434157</nct_id>
  </id_info>
  <brief_title>Association of the Neutrophil/Lymphocyte Ratio With Clinical Complications and Mortality in COVID-19 Patients</brief_title>
  <official_title>Association of the Neutrophil/Lymphocyte Ratio and Lymphocyte /Platelet Ratio With Clinical Complications and Mortality in COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Regional de Alta especialidad de Ixtapaluca</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital General de México Dr. Eduardo Liceaga</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Regional de Alta especialidad de Ixtapaluca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is little information about the clinical characteristics and risk factors of Covid-19&#xD;
      in Latin American countries considering the ethnic differences and the high prevalence of&#xD;
      obesity and cardiometabolic diseases. The aim of the study was to evaluate the association&#xD;
      between laboratory tests and the risk of complications in SARS-CoV-2 infection and to&#xD;
      determine their mortality risk factors in a sample of the Mexican population.&#xD;
&#xD;
      A retrospective cross-sectional study of the routinely collected data was performed in the&#xD;
      Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI), State of Mexico. Adult patients&#xD;
      (aged ≥18 years) with positive RT-PCR for SARS-CoV-2 and oxygen support that were admitted&#xD;
      between March 28 and May 5, 2020, were included&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data collection Data was collected deidentified admission from adult patients, with oxygen&#xD;
      therapy. Data were extracted from clinical medical records and the electronic database of&#xD;
      daily laboratory test results. Also, incomplete clinical records were included. The number of&#xD;
      cases in the area during the study period determined the sample size, no formal hypotheses&#xD;
      being implemented. All patients who met the inclusion criteria were included.&#xD;
&#xD;
      Study variables Demographic variables (sex and age), chronic medical histories (hypertension,&#xD;
      diabetes and cancer), laboratory plasma, and serum-based biomarkers, as well as the&#xD;
      mortality, mechanical ventilation, and length of stay, were considered. Leukocytosis was&#xD;
      considered as a leucocyte count above 10 x 103/mcL, a cut point of INL&gt; 10, d- dimer 500 U/L,&#xD;
      DHL&gt; 500U/L, low count of lymphocytes &lt; 0·5103/mcL as risk factors exposure to death and&#xD;
      mechanical ventilation.&#xD;
&#xD;
      A new variable was create combining the data of neutrophil count (ANC) and lymphocyte count&#xD;
      (ALC) to obtain the neutrophil-to-lymphocyte ratio (NLR) (calculated dividing the ANC by the&#xD;
      ALC).&#xD;
&#xD;
      Outcomes The hypothesis was formulated before the statistical analysis. Our primary outcomes&#xD;
      were to 1) To describe the clinical characteristics of the Mexican population with SARS-CoV-2&#xD;
      infection, and 2) To determine the mortality risk factors in Covid-19.&#xD;
&#xD;
      Secondary outcomes included 1) To identify the chronic diseases related to Covid-19 in&#xD;
      Mexican population and 2) To evaluate the differences in hematic and biochemical parameters&#xD;
      between survivors and no survivors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2020</start_date>
  <completion_date type="Actual">May 5, 2020</completion_date>
  <primary_completion_date type="Actual">May 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical complications and Mortality</measure>
    <time_frame>10 days</time_frame>
    <description>To main aim of the study is to evaluate clinical complicatios and mortality in mexican Covid-19 patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neutrophil-Lymphocyte and Lymphocyte-Platelet ratio</measure>
    <time_frame>10 days</time_frame>
    <description>To evaluate the association of the hematological ratios with the clinical complicatios and mortality in covid-19 patinets</description>
  </primary_outcome>
  <other_outcome>
    <measure>Hematic and biochemical parameters</measure>
    <time_frame>10 days</time_frame>
    <description>To evaluate the differences in hematic and biochemical parameters between survivors and no survivors</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronic diseases</measure>
    <time_frame>10 days</time_frame>
    <description>To identify the chronic diseases in the patientss´medical records associated with the pulmonary complications</description>
  </other_outcome>
  <enrollment type="Actual">221</enrollment>
  <condition>Covid-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include all hospitalized patients with the diagnosis of COVID-19 in the&#xD;
        Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI) that were admitted in the&#xD;
        Emergency ward, Intensive Care Unit (ICU) and all the reconversion areas.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients (aged ≥18 years)&#xD;
&#xD;
          2. Clinical (Positive RT-PCR for SARS-CoV-2 test) and radiological diagnosis of pulmonary&#xD;
             infection by COVID-19&#xD;
&#xD;
          3. Diagnosis of acute respiratory distress syndrome clinical panel in accordance with&#xD;
             Berlin 2012 criteria&#xD;
&#xD;
          4. Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous diagnosis of severe liver or kidney failure.&#xD;
&#xD;
          2. Patients with Human Immunodeficiency Virus (HIV) infection.&#xD;
&#xD;
          3. Patients with previous hematological diseases (Leukemia) that condition alterations in&#xD;
             blood counts.&#xD;
&#xD;
          4. Consumption of treatments with any type of immunosuppressants prior to admission that&#xD;
             conditions low lymphocytes.&#xD;
&#xD;
          5. Patients with a diagnosis of active or non-active cancer.&#xD;
&#xD;
          6. Absence of a clinical record for monitoring the data.&#xD;
&#xD;
          7. Pregnancy.&#xD;
&#xD;
          8. Patients referred from other institutions for their medical care. Clinical records of&#xD;
             patients who requested their voluntary discharge Clinical records that do not include&#xD;
             information of the course of COVID-19 infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Regional de Alta Especialidad de Ixtapaluca</name>
      <address>
        <city>Ixtapaluca</city>
        <state>State Of Mexico</state>
        <zip>56530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Regional de Alta especialidad de Ixtapaluca</investigator_affiliation>
    <investigator_full_name>Omar Ramos-Peñafiel</investigator_full_name>
    <investigator_title>Christian Ramos Peñafiel, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Clinical Complications</keyword>
  <keyword>Mortality Risk</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Neutrophil/Lymphocyte Ratio</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434157
org study id: NR-09-2020
nct id: NCT04434157
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Clinical complications and Mortality
time frame: 10 days
description: To main aim of the study is to evaluate clinical complicatios and mortality in mexican Covid-19 patients
measure: Neutrophil-Lymphocyte and Lymphocyte-Platelet ratio
time frame: 10 days
description: To evaluate the association of the hematological ratios with the clinical complicatios and mortality in covid-19 patinets
measure: Hematic and biochemical parameters
time frame: 10 days
description: To evaluate the differences in hematic and biochemical parameters between survivors and no survivors
measure: Chronic diseases
time frame: 10 days
description: To identify the chronic diseases in the patientss´medical records associated with the pulmonary complications
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital Regional de Alta especialidad de Ixtapaluca
investigator full name: Omar Ramos-Peñafiel
investigator title: Christian Ramos Peñafiel, MD, PhD
mesh term: COVID-19
sharing ipd: No