NCT04802083No Longer Available不适用
SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID-19) - An Expanded Access Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
This protocol provides participants with COVID-19 access to Soliris.
详细描述
This is an open-label, multicenter, expanded access protocol that will provide access to Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection with a clinical presentation consistent with COVID-19 associated organ injury, such as acute respiratory distress syndrome, stroke, or acute renal failure. Participants who qualify for emergency treatment (whether in an inpatient or outpatient setting) will be offered the opportunity to receive up to 7 infusions of Soliris over approximately 4 weeks.
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
- •Males or females ≥ 18 years of age and body weight ≥ 40 kg.
- •Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test).
- •Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day
- •In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile.
排除标准
- •Unresolved Neisseria meningitidis infection.
- •Known hypersensitivity to murine proteins or to an excipient of Soliris.
研究者
相似试验
No Longer Available
不适用
SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19COVID-19Pneumonia, ViralAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)NCT04355494Alexion Pharmaceuticals, Inc.
已完成
不适用
Real-World Treatment Study of Soliris (Eculizumab)ObservationalNCT06448715AstraZeneca11
终止
4 期
Endothelial Protection in Convalescent COVID-19 PatientsEndothelial DysfunctionInflammationThrombosisCOVID-19NCT05252923Pirogov Russian National Research Medical University2
已完成
4 期
TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center ExperienceCovid19NCT04730323FMH College of Medicine and Dentistry93
已完成
2 期
Complement Inhibitor Eculizumab in Clinical Islet TransplantationDiabetes MellitusNCT02727608Uppsala University3