Seraph®-100 Microbind® Affinity Blood Filter for the Treatment of COVID-19 Under Emergency Use Authorization: Data Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rate of known, expected, or unanticipated adverse device effects
研究概览
简要总结
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 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
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COVID-19 infection
- •Confirmed or imminent respiratory failure
- •At least one of the following conditions
- •Early acute lung injury (ALI) or early acute respiratory distress syndrome (ARDS)
- •Severe disease, defined as:
- •respiratory frequency ≥ 30 bpm,
- •blood oxygen saturation ≤ 93%,
- •partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
- •lung infiltrates > 50% within 24 to 48 hours
- •Life-threatening disease, defined as:
- •respiratory failure,
- •septic shock, and/or
- •multiple organ dysfunction or failure
排除标准
- •No Exclusion
结局指标
主要结局
Rate of known, expected, or unanticipated adverse device effects
时间窗: From the initiation of therapy through 24 hours after therapy has been completed
Monitor and report on adverse events and unanticipated adverse device effects experienced by patients receiving treatment with the Seraph®-100 for COVID-19, including but not limited to: bleeding, clotting, cardiac dysrhythmia, hypotension, increase in oxygen requirement, hemolytic anemia, and allergic/anaphylactic reaction
次要结局
- Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6(24 hours prior to therapy through 24 hours after therapy has been completed)
- Change in cardiovascular hemodynamic stability(24 hours prior to therapy through 24 hours after therapy has been completed)
- Change in cardiovascular hemodynamic support(24 hours prior to therapy through 24 hours after therapy has been completed)
- Change in pulmonary/respiratory status(24 hours prior to therapy through 24 hours after therapy has been completed)
- Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer(24 hours prior to therapy through 24 hours after therapy has been completed)
- Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP(24 hours prior to therapy through 24 hours after therapy has been completed)
- Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin(24 hours prior to therapy through 24 hours after therapy has been completed)
- Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC(24 hours prior to therapy through 24 hours after therapy has been completed)