Feasibility Study of Hematology Parameters in COVID-19 Disease

NCT04816630 | Completed FDA Device

• 1 other identifier: C71934
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Sepsis; Adults; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• COVID-19 diseased patients diagnosed clinically

  Within 12 hours from presentation to the emergency department

Other Outcomes (4)

• Initial Disposition: Hospitalization

  Within 12 hours from presentation to the emergency department

• Initial Disposition: ICU Admission

  Within 12 hours from presentation to the emergency department

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

  Within 72 hours from presentation to the emergency department

Study Arms (1)

CBC-Diff Monocyte Volume Width Distribution

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

Device: CBC-Diff Monocyte Volume Width Distribution

Interventions

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.

CBC-Diff Monocyte Volume Width Distribution

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

COVID-19; Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Tiffany Osborn, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 25, 2021
• Study Start: December 21, 2020
• Primary Completion: March 25, 2021
• Study Completion: September 22, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)