Post COVID-19 Biorepository
研究概览
地位
条件
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
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Luigi R Boccardi, BS
- 电话号码:9135884022
- 邮箱:lboccardi@kumc.edu
研究联系人备份
- 姓名:Christina Pantalunan, RN-BSN
- 电话号码:913-588-3851
- 邮箱:cpantalunan@kumc.edu
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
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
- 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.
- Patient is ≥ 18 years of age or older.
Exclusion Criteria:
- Participant declines to participate.
- Participant or healthcare surrogate is unable to provide informed consent.
学习计划
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
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
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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.