Covid19NCT04816630
Feasibility Study of Hematology Parameters in COVID-19 Disease
An observational study of Covid19 and Sepsis, run by Beckman Coulter, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- What is being tested?
- CBC-Diff Monocyte Volume Width Distribution
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2020to 22 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Prisoners
- <18 years of age
- >89 years of age
- Previously evaluated in this study
- No RT-PCR testing
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid19, Sepsis, Adults, Emergency Department
- Being tested
- CBC-Diff Monocyte Volume Width Distribution
- Medical subject headings
- COVID-19, Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC-Diff Monocyte Volume Width DistributionDevice
MDW is part of the CBC-Diff and will be collected but not reported to the physician. MDW will not impact standard of care.
| Study group | Role | What they receive |
|---|---|---|
| CBC-Diff Monocyte Volume Width Distribution | Monocyte Distribution Width [MDW] is part of the CBC with Differential. No intervention Receives: Device: CBC-Diff Monocyte Volume Width Distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 diseased patients
MDW's ability to identify COVID-19 negative versus COVID-19 positive patients using RT-PCR
Measured: Within 12 hours from presentation to the emergency department
Secondary outcomes (1)
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
Measured: Within 12 hours from presentation to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start21 Dec 2020
- Primary completion25 Mar 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tiffany Osborn, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816630
- Sponsor's protocol ID
- C71934
- Status last verified
- Dec 2021
- First submitted
- 15 Mar 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04816630
- Acronym / sponsor ID
- C71934
- Conditions
- Covid19, Sepsis, Adults, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBC-Diff Monocyte Volume Width Distribution | – | Device: CBC-Diff Monocyte Volume Width DistributionMonocyte Distribution Width [MDW] is part of the CBC with Differential. No intervention |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnancy
- Prisoners
- <18 years of age
- >89 years of age
- Previously evaluated in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBC-Diff Monocyte Volume Width DistributionMDW is part of the CBC-Diff and will be collected but not reported to the physician. MDW will not impact standard of care. | Device | CBC-Diff Monocyte Volume Width Distribution |
Primary outcome
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
1 secondary outcome
COVID-19 diseased patients diagnosed clinically
Time frame: Within 12 hours from presentation to the emergency department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Osborn, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Sepsis, run by Beckman Coulter, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 diseased patients (time frame: Within 12 hours from presentation to the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.