Feasibility Study of Hematology Parameters in COVID-19 Disease

Completed

• Conditions: Adults; Covid19; Sepsis; Emergency Department
• Interventions: Device: CBC-Diff Monocyte Volume Width Distribution

• Registration Number: NCT04816630
• Lead Sponsor: Beckman Coulter, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-21
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-24
• Primary Completion: 2021-03-25
• Study First Posted: 2021-03-25
• Study Completion: 2021-09-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-05
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CBC-Diff Monocyte Volume Width Distribution	CBC-Diff Monocyte Volume Width Distribution	Monocyte Distribution Width \[MDW\] is part of the CBC with Differential. No intervention

Primary Outcome Measures

Name	Time	Method
COVID-19 diseased patients	Within 12 hours from presentation to the emergency department	MDW's ability to identify COVID-19 negative versus COVID-19 positive patients using RT-PCR

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States