Feasibility Study of Hematology Parameters in COVID-19 Disease

• Sponsor: Beckman Coulter, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04816630
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Sepsis; Adults; Emergency Department	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 Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Dec 21, 2020
• Actual Primary Completion Date: Mar 25, 2021
• Actual Study Completion Date: Sep 22, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Other Outcome Measures

1. Initial Disposition: Hospitalization [Within 12 hours from presentation to the emergency department]

   MDW's ability to identify COVID-19 patients who require hospitalization

2. Initial Disposition: ICU Admission [Within 12 hours from presentation to the emergency department]

   MDW's ability to identify COVID-19 patients who require treatment in the intensive care unit

3. Increased Respiratory Requirements such as Non-invasive and Invasive Mechanical Interventions [Within 72 hours from presentation to the emergency department]

   MDW's ability to identify COVID-19 patients upon emergency department that may require increased respiratory requirements in 72 hours from presentation

4. COVID-19 Severity [Within 12 hours from presentation to the emergency department]

   MDW's ability to identify COVID-19 patient severity [mild, moderate, severe and critical]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Beckman Coulter, Inc.

Investigators

• Principal Investigator: Tiffany Osborn, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beckman Coulter, Inc.
• ClinicalTrials.gov Identifier: NCT04816630
• Other Study ID Numbers: C71934
• First Posted: Mar 25, 2021
• Last Update Posted: Dec 7, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: COVID-19; Emergencies

Study Results

No Results Posted as of Dec 7, 2021