Recombinant Human C1 Esterase Inhibitor (Ruconest®) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial in the US
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7
研究概览
简要总结
The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.
详细描述
Patients fulfilling all eligibility criteria will be randomized in a 2:1 ratio in an open-label controlled design to treatment with rhC1-INH in addition to SOC or SOC only starting on day 0. The first rhC1-INH treatment will be administered on the same day and continued for a total of 4 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years,
- •Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19 infection).
- •Evidence of pulmonary involvement on CT scan or X-Ray of the chest,
- •Symptom onset within the previous 10 days AND at least one additional risk factor for progression to mechanical ventilation: 1) arterial hypertension, 2) >50 years, 3) obesity (BMI>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) C-reactive protein of >35mg/L, 7) oxygen saturation at rest in ambient air of <94%
排除标准
- •Contraindications to the class of drugs under study (C1 esterase inhibitor);
- •History or suspicion of allergy to rabbits;
- •Women who are of childbearing potential and not using methods of contraception during the entire study period;
- •Pregnant or breastfeeding females or has a positive serum β-human chorionic gonadotropin (hCG) pregnancy test at screening;
- •Chronic liver disease (any Child-Pugh score B or C);
- •Currently admitted to an ICU or expected admission within the next 24 hours; and
- •Currently receiving invasive or non-invasive ventilation
研究组 & 干预措施
Ruconest
Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered.
干预措施: Ruconest (Drug)
Standard of Care
SOC
干预措施: Ruconest (Drug)
结局指标
主要结局
Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7
时间窗: Assessed on each day after enrollment (worst status) with the use of the WHO Ordinal Scale and the score on day 7 will be analyzed stratified by its baseline value
The disease severity on the 7-point WHO Ordinal Scale on Day 7 was the primary objective of this study. This endpoint had been suggested by the WHO for clinical trials in patients with Covid-19. The ordinal scale measures illness severity over time. The higher score, the worst outcome: meaning score 1, no limitation in activities and score 7, death.
次要结局
- Number of Days Hospitalized(between D0 and D90)
- Invasive (Mechanical) or Non-invasive Ventilation(Daily until day 14.)
- Time to Clinical Improvement(Daily until day 14)