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Post COVID-19 Biorepository

2021年9月28日 更新者:Leslie Spikes, MD、University of Kansas Medical Center
Establish a biorepository, clinical data registry, and radiographic image database from individuals who were COVID positive at one time and are being seen for outpatient follow-up or a separate study visit.

研究概览

地位

招聘中

详细说明

Living patients or their healthcare surrogates will provide informed consent prior to participation in the biorepository. Surrogate decision makers who cannot consent in person will be consented in accordance to the KUMC remote consent guidelines. Biospecimens to be collected include serum, plasma and whole blood. Blood samples will be collected during face-to-face encounters in the Post-COVID-19 clinic within the TUKHS pulmonary clinic or will be coordinated with other outpatient follow-up appointments (including separate procedure/lab-related visits) or separate study visits for ongoing, indepent studies. Samples will be collected at time of consent as well as at potential follow-up visits at approximately 3, 6, 12, and 12 months from enrollment. Blood samples will be processed, aliquoted, and stored at -80°C. A portion of the blood samples will be kept for DNA and RNA isolation, and a portion of plasma collected might be utilized to isolate peripheral blood mononuclear cells. Biospecimens will be labeled with the patient's study ID number, date of sample processing, and specimen type. Biospecimens will be stored through the duration of the study. If the patient chooses to withdraw consent, his or her samples in the biorepository will be destroyed. Biospecimens that have been previously used or disseminated will continue to be utilized. Future research may include whole genome testing, and these results will not be shared with the patient or their standard of care physician.

Patient data and historical radiographic imaging from after the date of consent will be collected using TUKHS medical records and stored in RedCap. The data to be collected is outlined in the data collection sheets.

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Kansas
      • Kansas City、Kansas、美国、66160
        • 招聘中
        • University of Kansas Medical Center
        • 首席研究员:
          • Leslie A Spikes, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The participant will be recruited from the population of recovering COVID-19 patients seen in the Post-COVID-19 clinic within the TUKHS pulmonary clinic or who are scheduled for other outpatient appointments or unrelated study visits for separate, ongoing studies at TUKHS.

描述

Inclusion Criteria:

  1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
  2. The participant has a previous diagnosis of COVID-19 confirmed by COVID-19 PCR or antibody testing and is being seen for outpatient follow-up.
  3. Patient is ≥ 18 years of age or older.

Exclusion Criteria:

  1. Participant declines to participate.
  2. Participant or healthcare surrogate is unable to provide informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:横截面

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Establish a Biorepository
大体时间:From Enrollment to 24 Months
Establish a collection of biospecimens from patients who have recovered from COVID-19.
From Enrollment to 24 Months
Develop Connections in Relation to Post-COVID Infection
大体时间:From Enrollment to 12 Months
Establish links between biospecimens, individual patient data and radiographic imaging, which will be collected and stored in RedCap.
From Enrollment to 12 Months
Develop of Patient Registry
大体时间:From Months 12 to 36
Provide biospecimens and unique patient data to researchers investigating COVID-19 and its recovery. Separate IRB approval will be required for these studies.
From Months 12 to 36

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Leslie A Spikes, MD、University of Kansas Medical Center
  • 研究主任:Luigi R Boccardi, BS、University of Kansas Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年2月8日

初级完成 (预期的)

2025年12月31日

研究完成 (预期的)

2026年7月15日

研究注册日期

首次提交

2021年5月11日

首先提交符合 QC 标准的

2021年5月11日

首次发布 (实际的)

2021年5月13日

研究记录更新

最后更新发布 (实际的)

2021年9月29日

上次提交的符合 QC 标准的更新

2021年9月28日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • STUDY#00146337

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The plan will be discussed between the Principal Investigator and the PI requesting access to Biospecimens.

IPD 共享支持信息类型

  • 研究协议
  • 知情同意书 (ICF)
  • 临床研究报告(CSR)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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