- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05052346
Association of the Neutrophil/Lymphocyte Ratio With Pulmonary Complications and Mortality in COVID-19 Patients
20. september 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Mexico City, Mexico, 06726
- Omar Ramos-Peñafiel
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Mexican patients diagnosed with active COVID-19 infection who require hospital care and who have peripheral blood counts at diagnosis.
Beskrivelse
Inclusion Criteria:
- Patients with active COVID-19 infection
Exclusion Criteria:
- Liver failure
- Active cancer
- Chronic renal failure
- AIDS
- Pregnancy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Respiratory Complications in COVID-19 patients
Tidsramme: 6 months
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To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications
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6 months
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Mortality in COVID-19 patients
Tidsramme: 6 months
|
To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications
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6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Adolfo Martinez Tovar, Hospital General de Mexico
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. marts 2020
Primær færdiggørelse (Faktiske)
5. maj 2020
Studieafslutning (Faktiske)
15. maj 2020
Datoer for studieregistrering
Først indsendt
31. juli 2020
Først indsendt, der opfyldte QC-kriterier
20. september 2021
Først opslået (Faktiske)
22. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NR-09-2020
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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