NCT04354714撤回2 期
A Pilot Study of Ruxolitinib to Combat COVID-19
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Overall survival
研究概览
简要总结
The investigators hypothesize that JAK 1/2 inhibition with ruxolitinib, an FDA approved treatment for intermediate or high-risk myelofibrosis, could have a similar effect in patients with severe COVID-19, quelling the immune-hyperactivation, allowing for clearance of the virus and reversal of the disease manifestations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •A diagnosis of advanced COVID-19 as defined by both of the following:
- •A positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (nasopharyngeal and oropharyngeal swab) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab
- •Critical disease manifested by any of the following:
- •Chest imaging (CT or chest X-ray permitted) with ≥ 50% lung involvement
- •Respiratory failure requiring invasive mechanical ventilation or supplementary oxygen with FiO2 ≥ 50%
- •Shock (defined as mean arterial pressure ≤ 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support
- •Cardiac dysfunction defined by:
- •New global systolic dysfunction with ejection fraction ≤ 40%
- •Takotsubo cardiomyopathy
- •New onset supraventricular or ventricular arrhythmias
- •Plasma troponin I ≥ 0.10 ng/mL in someone without previously documented troponin elevation beyond that level
- •Elevated plasma NT-proBNP in someone without documented prior elevation
- •If Age < 50, NT-proBNP > 450 pg/ml
- •If Age 50-74, NT-proBNP > 900 pg/ml
- •If Age ≥ 74, NT-proBNP > 1800 pg/ml
- •Receipt of investigational or off-label agents for COVID-19 (prior or ongoing) does not exclude eligibility.
- •Patients who have received autologous or allogeneic stem cell transplant are eligible at the discretion of the investigators.
- •18 years of age or older at the time of study registration
- •Adequate hematologic function defined as:
- •absolute neutrophil count ≥ 1000/mm3
- •platelet count ≥ 50,000/mm3 without growth factor or transfusion support for 7 days prior to screening
- •Creatinine clearance ≥ 15 mL/minute or receiving renal replacement therapy
- •Women of childbearing potential (defined as women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, or women who have had a tubal ligation) are required to have a negative pregnancy test and use two forms of acceptable contraception, including one barrier method, during participation in the study treatment period.
- •Male patients (if engaging in reproductive sex with a women of childbearing potential) are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the evaluation period.
- •Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
排除标准
- •Known allergy or intolerance to ruxolitinib or another JAK inhibitor.
- •Known or suspected active viral (including HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-
- •Virologic testing not required unless infection is suspected.
- •Pregnant and/or breastfeeding.
- •Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.
研究组 & 干预措施
Ruxolitinib
Experimental
-Ruxolitinib is an oral medication that will be given twice daily (BID). Dosing on Days 1 through 3 will be 5 mg BID; dosing on Days 4 through 10 will be 10 mg BID.
干预措施: Ruxolitinib (Drug)
Ruxolitinib
Experimental
-Ruxolitinib is an oral medication that will be given twice daily (BID). Dosing on Days 1 through 3 will be 5 mg BID; dosing on Days 4 through 10 will be 10 mg BID.
干预措施: Peripheral blood draw (Procedure)
结局指标
主要结局
Overall survival
时间窗: Through 28 days
次要结局
- Length of ICU stay(Through completion of follow-up (estimated to be 7 months))
- Duration on renal replacement therapy(Through completion of follow-up (estimated to be 7 months))
- Viral kinetics as measured by virologic failure(Through completion of follow-up (estimated to be 7 months))
- Number of adverse events as measured by CTCAE v. 5.0(Through completion of follow-up (estimated to be 7 months))
- Proportion of participants with detectable virus(Day 29)
- Length of hospital stay(Through completion of follow-up (estimated to be 7 months))
- Duration of ventilator use(Through completion of follow-up (estimated to be 7 months))
- Duration of vasopressors use(Through completion of follow-up (estimated to be 7 months))
研究者
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