Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition.
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.
详细描述
Recorded Endpoints:
- Mortality
- Time in the ICU
- Time on a ventilator
Administrative:
An Emergency FDA IND must be submitted (FDA form 3926) for each patient.
Subsequent to approval the primary investigator will obtain an authorization letter from Alexion Pharmaceuticals.
研究设计
- 研究类型
- Expanded Access
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
- •Age 18 or older.
- •Confirmed Covid-19 infection
- •ICU patient
排除标准
- •Active Neisseria infection.
- •Concomitant enrollment in another experimental/off-label immunosuppressive therapy trial.
研究者
Thomas Pitts, M.D.
Thomas C Pitts, M.D.
Hudson Medical