Study of Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Time to clinical outcome improvement
研究概览
简要总结
Studying the efficacy of IL-6 inhibition utilizing single or double dose subcutaneous administration of Sarilumab in patients with severe respiratory distress caused by COVID19 regarding improvement in oxygen demands and other clinical outcomes.
详细描述
At the time of writing this protocol, there does not exist any strategy to treat acute respiratory distress syndrome associated with COVID-19. Due to the overwhelming health crisis facing a large portion of the population, and due to lack of standardization or clinical approach to management of severe respiratory failure short of standard of care with oxygenation and supportive measures, we elected to embark on this study to evaluate the role of IL-6 stimulating the immune system and the effect of inhibiting signal propagation on clinical outcome.
For this study, Sarilumab, an FDA approved IL-6 receptor antagonist, currently used for severe rheumatoid arthritis, has been selected. The dose and administration of therapy used for the study conforms to the current FDA recommendation for the primary use of Sarilumab.
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
- Double (Investigator, Outcomes Assessor)
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 via centralized RT-PCR testing for SARS-CoV2 infection performed at BayCare Health System Laboratory or associated and accredited laboratory.
- •Subjects must be hospitalized.
- •Document fever of 100.4 F or more during hospitalization and prior to enrollment.
- •Evidence of abnormal chest imaging chest x-ray or CT.
- •Moderate to severe respiratory distress requiring oxygen supplementation as defined by criteria listed below.
- •"Oxygen saturation (Sao2) of 92% or less on room air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) of less than 200 mm Hg, on ventilator settings that include PEEP ≥5 cm H2O".
- •Subjects may have active co-infection with other respiratory pathogens.
- •Males and non-pregnant females at least 18 years of age.
排除标准
- •The subject or Legally Authorized Representative is unable to provide consent in person or by phone.
- •The subject is participating in any other clinical trial for treatment of COVID 19 or any other treatment related clinical trial for a concurrent disease. No plans for additional COVID trials.
- •The subject does not meet criteria for moderate to severe respiratory distress.
- •The presence of any of the following lab abnormalities. ANC <2000/mm3, Platelet count <50,000/mm3, ALT/AST >6x ULN
- •Prior utilization of any IL-6 inhibitors or receptor antagonists at any time in patient's life, JAK inhibitors, DMARDS(Except Hydroxychloroquine), long term, chronic steroid use (more than 6 months) or mTOR inhibitors.
- •The subject has history of organ or bone marrow transplant.
- •History of active or incompletely treated Tuberculosis (TB).
研究组 & 干预措施
Sarilumab
200 mg in 1.14 mL Subcutaneous x 1 or 2 dose(s)
干预措施: Sarilumab 200 MG/1.14 ML Subcutaneous Solution (Drug)
Placebo
Normal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s)
干预措施: Placebo (Drug)
结局指标
主要结局
Time to clinical outcome improvement
时间窗: Time to improvement up to 28 days
Time from randomization to improvement in oxygenation. Improvement in oxygenation is defined as SpO2/FiO2 improvement by 100 or greater.
次要结局
- Time to improvement in oxygenation(Time to improvement up to 28 days)
- The number of patients with a need for intubation(Up to 28 days)
- Time on ventilator(Up to 28 days)
- Hemodynamic improvement to normal range(Up to 28 days)
- Improvement or normalization in CBC(At 48 hours post intervention up to 28 days)
- Time to objective improvement noted on chest imaging(Up to 28 days)
- Time from randomization to hospital discharge(Up to 28 days)
- Death(Up to 28 days)
- Improvement or normalization in LDH(At 48 hours post intervention up to 28 days)
- Improvement or normalization in Lactic Acid(At 48 hours post intervention up to 28 days)
- Improvement or normalization in D-Dimer(At 48 hours post intervention up to 28 days)
- Fever resolution(Up to 28 days)
- Improvement or normalization in CMP(At 48 hours post intervention up to 28 days)
- Improvement or normalization in CRP(At 48 hours post intervention up to 28 days)
- Improvement or normalization in Procalcitonin(At 48 hours post intervention up to 28 days)
- Improvement or normalization in Ferritin(At 48 hours post intervention up to 28 days)
- Improvement or normalization in IL-6(At 48 hours post intervention up to 28 days)