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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63110
- Washington University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
COVID-19 diseased patients
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
COVID-19 diseased patients diagnosed clinically
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Initial Disposition: Hospitalization
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- C71934
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。