Covid-19NCT04434157
Association of the Neutrophil/Lymphocyte Ratio With Clinical Complications and Mortality in COVID-19 Patients
An observational study of Covid-19, run by Hospital Regional de Alta especialidad de Ixtapaluca at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid-19
- How many people
- 221 participants
- Where
- 1 siteMexico
- Study dates
- 28 Mar 2020to 5 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include all hospitalized patients with the diagnosis of COVID-19 in the Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI) that were admitted in the Emergency ward, Intensive Care Unit (ICU) and all the reconversion areas.
Who may be able to join
- Adult patients (aged ≥18 years)
- Clinical (Positive RT-PCR for SARS-CoV-2 test) and radiological diagnosis of pulmonary infection by COVID-19
- Diagnosis of acute respiratory distress syndrome clinical panel in accordance with Berlin 2012 criteria
- Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)
Who cannot join
- Previous diagnosis of severe liver or kidney failure.
- Patients with Human Immunodeficiency Virus (HIV) infection.
- Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts.
- Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes.
- Patients with a diagnosis of active or non-active cancer.
- Absence of a clinical record for monitoring the data.
- Pregnancy.
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional de Alta Especialidad de Ixtapaluca
Ixtapaluca, State of Mexico, 56530
About this study
Official title: Association of the Neutrophil/Lymphocyte Ratio and Lymphocyte /Platelet Ratio With Clinical Complications and Mortality in COVID-19 Patients
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
Read the 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
- Covid-19
- Keywords
- Clinical Complications, Mortality Risk, COVID-19, Neutrophil/Lymphocyte Ratio
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical complications and Mortality
To main aim of the study is to evaluate clinical complicatios and mortality in mexican Covid-19 patients
Measured: 10 days
Neutrophil-Lymphocyte and Lymphocyte-Platelet ratio
To evaluate the association of the hematological ratios with the clinical complicatios and mortality in covid-19 patinets
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start28 Mar 2020
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta especialidad de Ixtapaluca
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General de México Dr. Eduardo Liceaga
- Responsible party
- Principal investigator, Omar Ramos-Peñafiel, Hospital Regional de Alta especialidad de Ixtapaluca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434157
- Sponsor's protocol ID
- NR-09-2020
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the Neutrophil/Lymphocyte Ratio and Lymphocyte /Platelet Ratio With Clinical Complications and Mortality in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04434157
- Acronym / sponsor ID
- NR-09-2020
- Conditions
- Covid-19
- Keywords
- Clinical Complications, Mortality Risk, COVID-19, Neutrophil/Lymphocyte Ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Hospital Regional de Alta especialidad de IxtapalucaUniversity, hospital or other
- Collaborators
- Hospital General de México Dr. Eduardo Liceaga
- Study start
- 28 Mar 2020 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include all hospitalized patients with the diagnosis of COVID-19 in the Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI) that were admitted in the Emergency ward, Intensive Care Unit (ICU) and all the reconversion areas.
Key inclusion criteria (4 listed)
- Adult patients (aged ≥18 years)
- Clinical (Positive RT-PCR for SARS-CoV-2 test) and radiological diagnosis of pulmonary infection by COVID-19
- Diagnosis of acute respiratory distress syndrome clinical panel in accordance with Berlin 2012 criteria
- Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)
Key exclusion criteria (8 listed)
- Previous diagnosis of severe liver or kidney failure.
- Patients with Human Immunodeficiency Virus (HIV) infection.
- Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts.
- Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes.
- Patients with a diagnosis of active or non-active cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical complications and Mortality
Time frame: 10 days
To main aim of the study is to evaluate clinical complicatios and mortality in mexican Covid-19 patients
Neutrophil-Lymphocyte and Lymphocyte-Platelet ratio
Time frame: 10 days
To evaluate the association of the hematological ratios with the clinical complicatios and mortality in covid-19 patinets
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Hospital Regional de Alta especialidad de Ixtapaluca at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical complications and Mortality (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.