Feasibility Study of Hematology Parameters in COVID-19 Disease

Beckman Coulter

Status: Completed

Conditions: Emergency Department; Covid19; Adults; Sepsis

Treatments: Device: CBC-Diff Monocyte Volume Width Distribution

Study type: Observational

Funder types: Industry

Identifiers

NCT04816630

C71934

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

32 participants in 1 patient group

CBC-Diff Monocyte Volume Width Distribution

Description:

Monocyte Distribution Width \[MDW\] is part of the CBC with Differential. No intervention

Treatment:

Device: CBC-Diff Monocyte Volume Width Distribution