Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19

NCT04534712 | Completed

• 1 other identifier: yet to be assigned
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. An ideal marker for predicting course of this illness should be easily available and reproducible; as the disease burden has spread to third world countries whose healthcare system is resource limited. Our study is aimed to study the utility of lymphocyte- monocyte ratio in the early stages to predict the progression of COVID 19 pneumonia.

Conditions

Covid19

Keywords

LYMPHOCYTE MONOCYTE RATIO; COVID-19; DISEASE PROGRESSION

Outcome Measures

Primary Outcomes (1)

• progression

  disease progression equal or more than 2 stages

  28 days

Secondary Outcomes (1)

• mortality

  28 days

Study Arms (2)

PROGRESSION

Cohort A with patients who progressed to next stage of illness or continue to remain in the same stage

Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO

NON PROGRESSION

Cohort B with those who improved by two points on the ordinal scale without any further progression

Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO

Interventions

LYMPHOCYTE MONOCYTE RATIO DIAGNOSTIC_TEST

Absolute lymphicyte and absolute monocyte counts are recorded on admission of COVID -19 positive patient and ratio is derived. the patients are followed up for any progression of disease stage.

NON PROGRESSION; PROGRESSION

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients who are tested positive for COVID 19 and presented within 7 days of symptom onset will be included

You may qualify if:

• All adults of age 18-80 years tested positive for SARS-CoV-2 reverse-transcriptase - polymerase chain reaction (rt-PCR) and presented within 7 days of symptom(s) onset

You may not qualify if:

• Pregnancy
• Sepsis
• Malignancy
• Patients on immunosuppressant therapy
• Chronic inflammatory conditions
• Cases lost to follow up

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Sir Ganga Ram Hospital: collaborator

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

MeSH Terms

Conditions

COVID-19; Disease Progression

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DNB Trainee

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 1, 2020
• Study Start: September 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 1 year from the study completion till publication

Locations

IN (1)