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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434157
• Other study ID #: NR-09-2020
• Status: Completed
• Start date: March 28, 2020
• Est. completion date: May 5, 2020

Study information

• Verified date: June 2020
• Source: Hospital Regional de Alta especialidad de Ixtapaluca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19

Locations

Country	Name	City	State
Mexico	Hospital Regional de Alta Especialidad de Ixtapaluca	Ixtapaluca	State Of Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Regional de Alta especialidad de Ixtapaluca	Hospital General de México Dr. Eduardo Liceaga

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hematic and biochemical parameters	To evaluate the differences in hematic and biochemical parameters between survivors and no survivors	10 days
Other	Chronic diseases	To identify the chronic diseases in the patientss´medical records associated with the pulmonary complications	10 days
Primary	Clinical complications and Mortality	To main aim of the study is to evaluate clinical complicatios and mortality in mexican Covid-19 patients	10 days
Primary	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