- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04816630
Feasibility Study of Hematology Parameters in COVID-19 Disease
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Missouri
-
Saint Louis, Missouri, Forente stater, 63110
- Washington University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
CBC-Diff Monocyte Volume Width Distribution
Monocyte Distribution Width [MDW] is part of the CBC with Differential.
No intervention
|
MDW is part of the CBC-Diff and will be collected but not reported to the physician.
MDW will not impact standard of care.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
COVID-19 diseased patients
Tidsramme: 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
|
Within 12 hours from presentation to the emergency department
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
COVID-19 diseased patients diagnosed clinically
Tidsramme: 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
|
Within 12 hours from presentation to the emergency department
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Initial Disposition: Hospitalization
Tidsramme: Within 12 hours from presentation to the emergency department
|
MDW's ability to identify COVID-19 patients who require hospitalization
|
Within 12 hours from presentation to the emergency department
|
Initial Disposition: ICU Admission
Tidsramme: 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
|
Within 12 hours from presentation to the emergency department
|
Increased Respiratory Requirements such as Non-invasive and Invasive Mechanical Interventions
Tidsramme: 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
|
Within 72 hours from presentation to the emergency department
|
COVID-19 Severity
Tidsramme: Within 12 hours from presentation to the emergency department
|
MDW's ability to identify COVID-19 patient severity [mild, moderate, severe and critical]
|
Within 12 hours from presentation to the emergency department
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C71934
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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