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Validation of Biomarkers for Long COVID in the LIINC Viral Immunopathogenesis and Persistence Repeat Donor Cohort (VIPER) (VIPER)

2026年8月12日 更新者：University of California, San Francisco

The purpose of this study is to better understand the biological changes associated with Long COVID and to identify laboratory tests (biomarkers) that may help diagnose the condition and measure how it changes over time. Researchers will enroll people with Long COVID as well as people who have fully recovered after COVID-19 infection.

Participants will provide health information and biological samples, such as blood, saliva, stool, and, for some participants, tissue biopsies. These samples will be used to study the biological processes involved in Long COVID and to support the development of new diagnostic tests that may improve future research, clinical trials, and patient care.

研究概览

地位

招聘中

条件

详细说明

The lack of a biomarker for Long COVID (LC) is the single biggest obstacle to the development of a cure for this disabling infection-associated chronic condition (IACC). Development of biomarkers to date has been sluggish and uncoordinated, in part due to the lack of resources invested in this effort and in part due to the lack of a central biospecimen collection, distribution, and analytic resource to support the work of laboratories who are developing compelling assays for this condition using novel technologies. Currently, the work of assay development is highly siloed - individual laboratories working with relatively small numbers of samples from participants from individual cohorts with a variable degree of clinical phenotyping are developing individual assays that have not been robustly validated or compared head-to-head with similar assays. The result has been a lack of progress in advancing Long COVID diagnostics, which in turn has limited the development of Long COVID treatments and ultimately a cure.

The UCSF Viral Immunology and Persistence Repeat Donor Cohort (VIPER) program aims to address these challenges by serving as a central, gold-standard resource to support the development of biomarkers for Long COVID. Developed within the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC) research program (UCSF IRB # 20-30479) - one of the most highly visible and productive Long COVID studies in the world - VIPER will enroll and deeply phenotype individuals with well-defined Long COVID as well as those who have fully recovered from SARS-CoV-2 infection. All participants will undergo a combination of non-invasive (blood, saliva, stool) and invasive (tissue biopsy) sampling using established procedures, with collection of ample amounts of biological specimens to support downstream biomarker development. VIPER specimens will be centrally housed and distributed to collaborating laboratories, who while blinded to the characteristics of the participants will generate measurements that are shared with a central data core for analysis. This will enable the determination of how each assay performs relative to both clinical and laboratory "gold standards" and how each assay performs relative to each other.

Following the identification and validation of these biomarkers, this program will also determine how these tests can be used to assess eligibility and outcomes in LC trials. Ultimately, the goal of VIPER is to promote the development of biomarker tests that can be utilized in the clinic setting to identify those who are likely to benefit from therapeutics targeting each of the mechanisms of Long COVID.

研究类型

观察性的

注册 (估计的)

150

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

  • 美国
    • California
      • San Francisco、California、美国、94110
        • 招聘中
        • Zuckerberg San Francisco General Hospital
        • 接触：
        • 首席研究员：
          • Michael Peluso

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

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

The study population will include adults with well-characterized Long COVID and adults who have recovered following SARS-CoV-2 infection. Participants will be enrolled from the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC) research program and through community outreach and referral efforts. The study aims to include individuals with a range of Long COVID symptom patterns and durations to support research on the biological mechanisms of the condition.

描述

Inclusion Criteria:

  • Willing and able to provide written informed consent, and
  • Age >/= 18 years, and
  • Either:

History of a SARS-CoV-2 infection resulting in Long COVID symptoms, confirmed by the investigator, or

Exposure to SARS-CoV-2 without establishment of Long COVID.

  • Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC).
  • Enrolled or willing to be referred for a gut biopsy procedure under related IRB-approved protocols.

Exclusion Criteria:

  • Self-reported or documented chronic anemia with hemoglobin < 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.
  • Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

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

队列和干预

团体/队列
Long COVID
People experiencing Long COVID symptoms
Recovered
People who have fully recovered from their COVID infection(s)

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
参加者性别
大体时间：基线访问
参与基线访问的男性和女性比例。
基线访问
Participant age
大体时间：Baseline visit
The median age of study participants at enrollment
Baseline visit
Participant race/ethnicity
大体时间：Baseline visit
The proportion of participants from each demographic group
Baseline visit
Proportion of participants previously hospitalized
大体时间：Baseline visit
The proportion of participants who were previously hospitalized
Baseline visit
Colonoscopy Completed
大体时间：Baseline visit
The proportion of participants completing a research colonoscopy for the study
Baseline visit

次要结果测量

结果测量
措施说明
大体时间
Protocol complete
大体时间：Up to 6 weeks from baseline
The proportion of enrolled participants who complete all study activities
Up to 6 weeks from baseline

其他结果措施

结果测量
措施说明
大体时间
Long COVID Symptom Assessment
大体时间：Screening, baseline, and up to 6 weeks
Participant-reported assessment for presence and severity of persistent post-COVID-19 symptoms
Screening, baseline, and up to 6 weeks
Qualify of Life Assessment (Global Health Score)
大体时间：Screening, baseline, and up to 6 weeks
Measure of overall health-related quality of life
Screening, baseline, and up to 6 weeks
Mental Health Symptom Assessment
大体时间：Screening visit
An instrument such as the PHQ-9 will be used to assess participants' overall mental health status. These will include questions about anxiety and depression, independent of Long COVID association.
Screening visit
Cognitive Symptom Assessment
大体时间：Screening visit
An instrument such as the Everyday Cognition survey will be used to asses perceived changes in everyday cognitive function across domains compared to participants' pre-COVID baselines.
Screening visit
Fatigue Symptom Assessment
大体时间：Baseline and up to 6 weeks
An instrument such as the FACIT-Fatigue will be used to assess fatigue severity and its impact on daily activities.
Baseline and up to 6 weeks
Gastrointestinal Symptom Assessment
大体时间：Baseline and up to 6 weeks
An instrument such as the Modified Gastrointestinal Symptom Rating Scale (GSRS) will be used to assess the severity of gastrointestinal symptoms across multiple symptom domains.
Baseline and up to 6 weeks
Neurocognitive Function Assessment
大体时间：Baseline and up to 6 weeks
A computer-based neurocognitive test such as CNS Vital Signs will be used to assess cognitive function across multiple domains including memory, attention, psychomotor speed, and executive function.
Baseline and up to 6 weeks
Physical Function Symptom Assessment
大体时间：Baseline and up to 6 weeks
An instrument such as the PROMIS Physical Function will be used to assess participants' ability to perform physical activities of daily living.
Baseline and up to 6 weeks
Autonomic Symptom Assessment
大体时间：Baseline and up to 6 weeks
A questionnaire such as the COMPASS-31 or Orthostatic Hypotension Questionnaire (OHQ) will be used to assess autonomic nervous system symptoms across symptom domains.
Baseline and up to 6 weeks
Post-Exertional Malaise Symptom Assessment
大体时间：Baseline and up to 6 weeks
An instrument such as the DSQ-PEM will be used to assess the severity of post-exertional malaise
Baseline and up to 6 weeks
Grip Strength Test
大体时间：Up to 6 weeks from baseline
Objective measure of hand grip strength using a hand dynamometer
Up to 6 weeks from baseline
30-Second Sit-to-Stand Test
大体时间：Up to 6 weeks from baseline
Objective performance test measuring the number of full stands from a seated position completed in 30 seconds
Up to 6 weeks from baseline
Active Standing Test
大体时间：Up to 6 weeks from baseline
Objective measurement of changes in heart rate and blood pressure upon transition from lying/sitting to standing
Up to 6 weeks from baseline

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。

赞助

University of California, San Francisco

合作者

PolyBio Research Foundation

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)

2026年5月18日

初级完成 (估计的)

2031年5月15日

研究完成 (估计的)

2031年5月15日

研究注册日期

首次提交

2026年8月7日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 25-45159

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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