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临床试验/NCT04786301
NCT04786301Unknown不适用

Severe Acute Respiratory Infection - Preparedness

University of Washington2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2020年4月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,200
试验地点
2
主要终点
Ventilator-free days (VFD)

研究概览

简要总结

Severe Acute Respiratory Infection (SARI) is defined by the World Health Organization (WHO) as acute respiratory infection with a history of fever ≥38°C and cough for less than 10 days duration that requires hospital admission. SARI-PREP is a multi-center consortium funded by the CDC Foundation being assembled with the goal of providing the infrastructure to rapidly collect prospective data on clinical risks and outcomes, hospital-level stress, and biologic specimens that will aid in the rapid development of diagnostic and treatment approaches. A current example of a form of SARI to be targeted by SARI-PREP is COVID-19 the acute respiratory infectious disease caused by SARS-CoV-2 infection. COVID-19 has a broad set of manifestations and severity with a subset of affected patients developing severe disease leading to respiratory failure and other forms of organ dysfunction. As with many outbreaks of novel viral pathogens causing SARI there was no efficacious therapeutic intervention at the beginning of the COVID-19 pandemic. Furthermore, while there is emerging knowledge of clinical risks for severe COVID-19, there remains a paucity of information about the viral dynamics and host responses that might indicate a patient is at high risk for poor outcomes.

The COVID-19 pandemic will be the initial target of the SARI-PREP consortium with the overall goal of developing a multi-institutional collaborative network of Acute Care Hospitals that will rapidly enroll, sample, and follow patients admitted with severe COVID-19 and to develop research protocols to rapidly determine demographic, clinical, host molecular, virologic, and institutional correlates of outcome. Overall, the information gained from this effort will help to rapidly inform and improve clinical management of epidemic/pandemic SARI patients.

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
Female
接受健康志愿者

入选标准

  • Admission to an acute care or intensive care unit with a clinical syndrome of lower respiratory tract infection suspicious for viral SARI:
  • AND (radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR SpO2 ≤ 94% on room air OR requiring new supplemental oxygen (above baseline if preexisting) OR requiring invasive or non-invasive mechanical ventilation).
  • confirmed viral cause for SARI by respiratory viral RT-PCR testing.

排除标准

  • Prisoners or wards of the state
  • Inability to consent or lack of availability of legal surrogate
  • Do not attempt resuscitation/do not intubate status on admission

结局指标

主要结局

Ventilator-free days (VFD)

时间窗: 30 days

Number of days alive and free of mechanical ventilation

次要结局

  • World Health Organization respiratory failure ordinal score(30 days)
  • Mortality(28-day and 90-day)
  • Organ failure free days(30 days)

研究者

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

Laura Evans

Associate Professor, Pulmonary, Critical Care and Sleep Medicine

University of Washington

研究点 (2)

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