Status:
COMPLETED
Feasibility Study of Hematology Parameters in COVID-19 Disease
Lead Sponsor:
Beckman Coulter, Inc.
Conditions:
Covid19
Sepsis
Eligibility:
All Genders
18-89 years
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 symptom...
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04816630
Start Date
December 21 2020
End Date
September 22 2021
Last Update
December 7 2021
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110