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临床试验/NCT05471011
NCT05471011进行中(未招募)不适用

Multi-Dimensional Outcome Prediction Algorithm for Hospitalized COVID-19 Patients

University of California, Los Angeles7 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年8月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
600
试验地点
7
主要终点
New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death within one year

研究概览

简要总结

Severe acute respiratory syndrome coronavirus 2-mediated coronavirus disease (COVID-19) is an evolutionarily unprecedented natural experiment that causes major changes to the host immune system. We propose to develop a test that accurately predicts short- and long-term (within one-year) outcomes in hospitalized COVID-19 patients broadly reflecting US demographics who are at increased risk of adverse outcomes from COVID-19 using both clinical and molecular data. We will enroll patients from a hospitalized civilian population in one of the country's largest metropolitan areas and a representative National Veteran's population.

详细描述

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-mediated coronavirus disease (COVID-19) is an evolutionarily unprecedented natural experiment that causes major changes to the host immune system. Several high risk COVID-19 populations have been identified. Older adults, males, persons of color, and those with certain underlying health conditions (e.g., diabetes mellitus, obesity, etc.) are at higher risk for severe disease from COVID-19. While it is too soon to fully understand the impact of COVID-19 on overall health and well-being, there are already several reports of significant sequelae, which appear to correlate with disease severity. There is a clear and urgent need to develop prediction tests for adverse short- and long-term outcomes, especially for high-risk COVID-19 populations. We hypothesize that complementary multi-dimensional information gathered near the time of symptom onset can be used to predict new onset or worsening frailty, organ dysfunction and death within one year after COVID-19 onset. A single parameter provides limited information and is incapable of adequately characterizing the complex biological responses in symptomatic COVID-19 to predict outcome. Since they were designed for other illnesses, it is unlikely that existing clinical tools, such as respiratory, cardiovascular, and other organ function assessment scores, will precisely assess the long-term prognosis of this novel disease. Our extensive experience in biomarker development suggests that integrating molecular and clinical data increases prediction accuracy of long-term outcomes. We have chosen to test our hypothesis in a population reflecting US-demographics that is at increased risk of adverse outcomes from COVID-19. We will enroll patients, broadly reflecting US demographics, from a hospitalized civilian population in one of the country's largest metropolitan areas and a representative National Veteran's population. We anticipate that a prediction test that performs well in this hospitalized patient group will: help guide triaging and treatment decisions and, therefore, reduce morbidity and mortality rates, enhance patient quality of life, and improve healthcare cost-effectiveness. More accurate prognostic information will also assist clinicians in framing goals of care discussions in situations of likely futility and assist patients and families in this decision-making process. Finally, it will provide a logical means for allocating resources in short supply, such as ventilators or therapeutics with limited availability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Symptomatic COVID-19 infection with hospital admission
  • •Age 18 and above
  • •Informed consent

排除标准

  • •Absence of symptomatic COVID-19 infection with hospital admission
  • •Age 17 or below
  • •No informed consent

研究组 & 干预措施

civilian

干预措施: Blood and nasal swab sampling (Other)

Veteran

干预措施: Blood and nasal swab sampling (Other)

结局指标

主要结局

New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death within one year

时间窗: From hospital admission to one year

The primary outcome clinical composite endpoints that include new onset or worsening frailty, single organ dysfunction, multi organ dysfunction, and death within one year will include a follow-up period of time of at least 52 weeks after initial enrollment encounter. The assessment of time to event (outcome events will include various frailty measurement tools including short physical performance battery, laboratory test-based organ function assessment measures, and survival status as per publicly-accessible databases) will consist of calculating the time difference between first outcome event and baseline encounter date.

次要结局

  • New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death at time of discharge(From hospital admission to time of discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario C. Deng

Professor of Medicine

University of California, Los Angeles

研究点 (7)

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