Covid19NCT05052346
Association of the Neutrophil/Lymphocyte Ratio With Pulmonary Complications and Mortality in COVID-19 Patients
An observational study of Covid19 and Pulmonary Complication, run by Hospital General de Mexico at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, Pulmonary Complication
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 30 Mar 2020to 15 May 2020
- How long will I take part?
- 1 Month
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mexican patients diagnosed with active COVID-19 infection who require hospital care and who have peripheral blood counts at diagnosis.
Who may be able to join
- Patients with active COVID-19 infection
Who cannot join
- Liver failure
- Active cancer
- Chronic renal failure
- AIDS
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Pulmonary Complication
- Keywords
- Pulmonary Complications, Mortality, 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.
Respiratory Complications in COVID-19 patients
To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications
Measured: 6 months
Mortality in COVID-19 patients
To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start30 Mar 2020
- Primary completion5 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 200 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico
- Investigators
- Adolfo Martinez Tovar, Study director, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052346
- Sponsor's protocol ID
- NR-09-2020
- Status last verified
- Sep 2021
- First submitted
- 31 Jul 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. 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 Pulmonary Complications and Mortality in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05052346
- Acronym / sponsor ID
- NR-09-2020
- Conditions
- Covid19, Pulmonary Complication
- Keywords
- Pulmonary Complications, Mortality, COVID-19, Neutrophil/Lymphocyte Ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 22 Sep 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mexican patients diagnosed with active COVID-19 infection who require hospital care and who have peripheral blood counts at diagnosis.
Key inclusion criteria (1 listed)
- Patients with active COVID-19 infection
Key exclusion criteria (5 listed)
- Liver failure
- Active cancer
- Chronic renal failure
- AIDS
- Pregnancy
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
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
Mortality in COVID-19 patients
Time frame: 6 months
To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications
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 22 Sep 2021.
- Individual participant dataSharing planned: No. All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws
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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.
Adolfo Martinez Tovar study director
Hospital General de Mexico
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 Covid19 and Pulmonary Complication, run by Hospital General de Mexico 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 1 inclusion and 5 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 22 Sep 2021. 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?
Respiratory Complications in COVID-19 patients (time frame: 6 months). 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 22 Sep 2021.