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

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ClinicalTrials.gov Identifier: NCT04534712
Recruitment Status : Not yet recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborator:
Sir Ganga Ram Hospital
Information provided by (Responsible Party):
VAMSIDHAR, Sir Ganga Ram Hospital

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.

Condition or disease Intervention/treatment
Covid19 Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : February 1, 2021

Group/Cohort Intervention/treatment
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
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
Cohort B with those who improved by two points on the ordinal scale without any further progression
Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO
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.




Primary Outcome Measures :
  1. progression [ Time Frame: 28 days ]
    disease progression equal or more than 2 stages


Secondary Outcome Measures :
  1. mortality [ Time Frame: 28 days ]
    end outcome of the patients diagnosed of COVID-19 infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534712


Contacts
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Contact: vamsidhar amburu, MD +919814866818 rahdismav_a@yahoo.com

Locations
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India
Sir Ganga Ram Hospital
New delhi, Delhi, India, 110060
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Sir Ganga Ram Hospital
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Responsible Party: VAMSIDHAR, DNB Trainee, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT04534712    
Other Study ID Numbers: yet to be assigned
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD data shall be shared on request basis.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 1 year from the study completion till publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VAMSIDHAR, Sir Ganga Ram Hospital:
LYMPHOCYTE MONOCYTE RATIO
COVID-19
DISEASE PROGRESSION
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes