NCT04816630

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: —

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.

Conditions

• Covid19
• Sepsis
• Adults
• Emergency Department

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-21
• Primary completion: 2021-03-25
• Completion: 2021-09-22
• First posted: 2021-03-25
• Last updated: 2021-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study