Feasibility Study of Hematology Parameters in COVID-19 Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Covid19; Emergency Department; Adults
• Intervention / Treatment: Device: CBC-Diff Monocyte Volume Width Distribution

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult (18 to 89 years) of all race and ethnicities presenting to the emergency department with symptoms suggestive of COVID-19 or respiratory infection and whose assessment includes a CBC-DIFF and microbial testing to include RT-PCR for SARS-CoV-2

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial Disposition: Hospitalization	MDW's ability to identify COVID-19 patients who require hospitalization	Within 12 hours from presentation to the emergency department
Initial Disposition: ICU Admission	MDW's ability to identify COVID-19 patients who require treatment in the intensive care unit	Within 12 hours from presentation to the emergency department
Increased Respiratory Requirements such as Non-invasive and Invasive Mechanical Interventions	MDW's ability to identify COVID-19 patients upon emergency department that may require increased respiratory requirements in 72 hours from presentation	Within 72 hours from presentation to the emergency department
COVID-19 Severity	MDW's ability to identify COVID-19 patient severity [mild, moderate, severe and critical]	Within 12 hours from presentation to the emergency department

Collaborators and Investigators

• Sponsor: Beckman Coulter, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 5, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Emergencies
• Other Study ID Numbers: C71934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No