NCT05052346

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

July 31, 2020

Last Update Submit

September 20, 2021

Conditions

Keywords

Pulmonary ComplicationsMortalityCOVID-19Neutrophil/Lymphocyte Ratio

Outcome Measures

Primary Outcomes (2)

  • Respiratory Complications in COVID-19 patients

    To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications

    6 months

  • Mortality in COVID-19 patients

    To assess the relationship of the Neutrophil-Lymphocyte and Lymphocyte-Platelet index on respiratory complications

    6 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with active COVID-19 infection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omar Ramos-Peñafiel

Mexico City, 06726, Mexico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Adolfo Martinez Tovar

    Hospital General de Mexico

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2020

First Posted

September 22, 2021

Study Start

March 30, 2020

Primary Completion

May 5, 2020

Study Completion

May 15, 2020

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

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

Locations