Clinical trial NCT04816630: Feasibility Study of Hematology Parameters in COVID-19 Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Sepsis
Adults
Emergency Department
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult (18 to 89 years) of all race and ethnicities presenting to the emergency department with symptoms suggestive of COVID-19 or respiratory infection and whose assessment includes a CBC-DIFF and microbial testing to include RT-PCR for SARS-CoV-2

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.

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

Primary outcomes:
measure: COVID-19 diseased patients
timeFrame: Within 12 hours from presentation to the emergency department
Secondary outcomes:
measure: COVID-19 diseased patients diagnosed clinically
timeFrame: Within 12 hours from presentation to the emergency department
Other outcomes:
measure: Initial Disposition: Hospitalization
timeFrame: Within 12 hours from presentation to the emergency department
measure: Initial Disposition: ICU Admission
timeFrame: Within 12 hours from presentation to the emergency department
measure: Increased Respiratory Requirements such as Non-invasive and Invasive Mechanical Interventions
timeFrame: Within 72 hours from presentation to the emergency department
measure: COVID-19 Severity
timeFrame: Within 12 hours from presentation to the emergency department
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tiffany Osborn, MD
role: PRINCIPAL_INVESTIGATOR
References: