Feasibility Study of Hematology Parameters in COVID-19 Disease

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816630
• Other study ID #: C71934
• Status: Completed
• Start date: December 21, 2020
• Est. completion date: September 22, 2021

Study information

• Verified date: December 2021
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 22, 2021
• Est. primary completion date: March 25, 2021
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Adults
• COVID-19
• Covid19
• Emergencies
• Emergency Department
• Sepsis

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.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Initial Disposition: Hospitalization	MDW's ability to identify COVID-19 patients who require hospitalization	Within 12 hours from presentation to the emergency department
Other	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
Other	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
Other	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
Primary	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	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