- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052346
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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 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
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
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
Investigators
- 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)
March 30, 2020
Primary Completion (Actual)
May 5, 2020
Study Completion (Actual)
May 15, 2020
Study Registration Dates
First Submitted
July 31, 2020
First Submitted That Met QC Criteria
September 20, 2021
First Posted (Actual)
September 22, 2021
Study Record Updates
Last Update Posted (Actual)
September 22, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted