Feasibility Study of Hematology Parameters in COVID-19 Disease

NCT ID: NCT04816630

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2021-09-22

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.

Conditions

Covid19; Sepsis; Adults; Emergency Department

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CBC-Diff Monocyte Volume Width Distribution

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

CBC-Diff Monocyte Volume Width Distribution

Intervention Type: DEVICE

MDW is part of the CBC-Diff and will be collected but not reported to the physician. MDW will not impact standard of care.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Coulter, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiffany Osborn, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

C71934

Identifier Type: -

Identifier Source: org_study_id