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Completed

NCT Number: NCT04816630

Feasibility Study of Hematology Parameters in COVID-19 Disease

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.

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Key information

Conditions

Covid19 Adults COVID-19 Coronaviridae Infections Coronavirus Infections Disease Attributes Emergencies Emergency Department Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome Virus Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBC-Diff Monocyte Volume Width Distribution

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.

Primary outcomes

  1. COVID-19 diseased patients

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to identify COVID-19 negative versus COVID-19 positive patients using RT-PCR

Secondary outcomes

  1. COVID-19 diseased patients diagnosed clinically

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to identify COVID-19 diseased patients versus site's COVID-19 diagnosis, including those that were RT-PCR negative

Other outcomes

  1. Initial Disposition: Hospitalization

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to identify COVID-19 patients who require hospitalization

  2. Initial Disposition: ICU Admission

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to identify COVID-19 patients who require treatment in the intensive care unit

  3. Increased Respiratory Requirements such as Non-invasive and Invasive Mechanical Interventions

    Time frame: Within 72 hours from presentation to the emergency department

    MDW's ability to identify COVID-19 patients upon emergency department that may require increased respiratory requirements in 72 hours from presentation

  4. COVID-19 Severity

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to identify COVID-19 patient severity [mild, moderate, severe and critical]

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2021
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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