Clinical Trials Directory

Trials / Completed

CompletedNCT04434157

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
221 (actual)
Sponsor
Hospital Regional de Alta especialidad de Ixtapaluca · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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

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.

Conditions

Timeline

Start date
2020-03-28
Primary completion
2020-05-05
Completion
2020-05-05
First posted
2020-06-16
Last updated
2020-06-16

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT04434157. Inclusion in this directory is not an endorsement.