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

September 20, 2021 updated by: Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico

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

The Coronavirus Disease-19 (COVID-19) pandemic is currently a priority for health services worldwide. Unlike the Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) epidemic in 2012, the COVID-19 shows specific alterations in the white blood cell count, accentuated in severe cases, and with respiratory failure. Among the most relevant data are both lymphopenia, thrombocytopenia, and eosinopenia. The Neutrophil Lymphocyte Index has been beneficial in the evaluation of infectious respiratory processes, showing a sensitivity similar to scales such as CURB65 (Confusion, Uremia, Respiratory rate, BP, age ≥ 65 years). Because COVID-19 infection shows alterations in the blood cell ratio, these indices may be useful in evaluating patients with COVID-19 infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The hematological alterations in patients with COVID-19 divided into two aspects: the main ones, the global leukocyte count, and the individual counts. Most of the information about the behavior of blood counts come from cases attended in Wuhan, China. At the Zhongnan Hospital in Hubei Province, identified that the lymphocyte count was lower in critically ill patients. At the same time, the leukocyte counts were higher in deaths associated with COVID-19, this elevation being mainly of neutrophils. The lymphopenia is also a constant data in COVID-19 (47.4%), especially in cases that entered the Intensive Care Unit. As in community pneumonia, severe lymphopenia has associated with a high risk of death. A relationship between neutrophils and lymphocytes is called the Neutrophil-Lymphocyte index. This index is especially useful for predicting respiratory complications, such as for COVID-19, where mortality ranges from 2-9% compared to the 2012 epidemic (10%) or Middle East Respiratory Syndrome (37%). In Mexico, there is a high prevalence of chronic diseases that increase the risk of COVID-19 infection. This study's main objective is to identify the association of blood abnormalities on respiratory complications associated with COVID-19 infection. All data were obtained from the clinical records of patients treated by COVID-19.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 06726
        • Omar Ramos-Peñafiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mexican patients diagnosed with active COVID-19 infection who require hospital care and who have peripheral blood counts at diagnosis.

Description

Inclusion Criteria:

  • Patients with active COVID-19 infection

Exclusion Criteria:

  • Liver failure
  • Active cancer
  • Chronic renal failure
  • AIDS
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Respiratory Complications in COVID-19 patients
Time Frame: 6 months
To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications
6 months
Mortality in COVID-19 patients
Time Frame: 6 months
To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital General de Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Adolfo Martinez Tovar, Hospital General de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NR-09-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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