Feasibility Study of Hematology Parameters in COVID-19 Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the potential for MDW and other CPD parameters (measured with CBC-DIFF) to identify COVID-19 diseased adult individuals presenting to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care includes CBC-DIFF and microbial testing.

Detailed Description
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The objective of this study is to evaluate MDW and/or combination(s) of hematology parameters that best identify patients with COVID-19 disease who tested SAR-CoV-2 positive by standard of care (SOC) COVID-19 testing. A feasibility study of consecutive adult patients who presented to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care testing involves a CBC-DIFF and microbial testing including RT-PCR testing for SARS-CoV-2 will be enrolled. This study will evaluate MDW and other CPD parameters performance in COVID-19 patients and the ability of MDW to identify RT-PCR positive COVID-19 patients as well as potential added value to RT-PCR tests of MDW. A minimum of 50 COVID-19 positive and 150 COVID-19 negative patients meeting inclusion criteria will be evaluated. Patients with symptoms suggestive of COVID-19 and who have RT-PCR test samples drawn will be retested on the DxH900 hematology analyzer to capture baseline MDW results. In addition, a retrospective data extraction will be performed for those patient samples tested during the Post Market study during the COVID-19 pandemic that meet the revised study population.

Official Title
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Feasibility Study to Evaluate Performance of MDW and Other Hematology Parameters for Identification of COVID-19 Disease and Clinical Progression in Adult Hospitalized Patients - Washington University

Conditions
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Covid19, Sepsis, Adults, Emergency Department

Intervention / Treatment
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* Device: CBC-Diff Monocyte Volume Width Distribution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients [18-89 years of age] Present to the Emergency Department With symptoms suggestive of COVID-19 or respiratory infection Whose assessment includes CBC-Diff and RT-PCR testing Exclusion Criteria: Pregnancy Prisoners <18 years of age >89 years of age Previously evaluated in this study No RT-PCR testing Sample age >2 hours from time of draw Instrument flags, including vote outs and review flags for the MDW parameter Samples stored in refrigerated temperatures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CBC-Diff Monocyte Volume Width Distribution<br>Monocyte Distribution Width [MDW] is part of the CBC with Differential. No intervention | Device: CBC-Diff Monocyte Volume Width Distribution<br>* MDW is part of the CBC-Diff and will be collected but not reported to the physician. MDW will not impact standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 diseased patients | MDW's ability to identify COVID-19 negative versus COVID-19 positive patients using RT-PCR | Within 12 hours from presentation to the emergency department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 diseased patients diagnosed clinically | MDW's ability to identify COVID-19 diseased patients versus site's COVID-19 diagnosis, including those that were RT-PCR negative | Within 12 hours from presentation to the emergency department |