NCT04372602已完成2 期
A Pilot Study of Duvelisib to Combat COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Overall Survival as Measured by Number of Participants Alive Through 28 Days
研究概览
简要总结
The exceedingly high mortality rates of severe and critical COVID-19 warrant the identification and evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. Based on preclinical data from this institution and others, the investigators hypothesize that PI3K inhibition with duvelisib could potentially quell aberrant hyperactivtation of the innate immune system, preferentially polarize macrophages, reduce pulmonary inflammation, and limit viral persistence, thereby improving patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Blocks of 10 patients will be used to allocate patients to duvelisib or placebo
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 both of the following:
- •as a positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (e.g. nasopharyngeal, nasal, oropharyngeal swab, or saliva) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab with an FDA approved assay.
- •Critical disease manifested by any of the following:
- •Chest imaging with ≥ 50% lung involvement
- •Respiratory failure requiring invasive mechanical ventilation, non-invasive mechanical ventilation (eg. BiPAPA, OptiFlow), supplementary oxygen with FiO2 ≥ 6 LPM or extracorporeal membrane oxygenation (ECMO)
- •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
- •Patients who have received prior investigational or off-label agents for COVID-19 does not exclude eligibility.
- •At least 18 years of age at the time of study registration
- •Adequate hematologic function defined as absolute neutrophil count ≥1000/mm3 and 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
- •Aminotransferase (AST/ALT) levels <3x the upper limit of normal
- •Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
- •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 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.
排除标准
- •Known allergy or intolerance to duvelisib or another PI3K inhibitor.
- •Known or suspected active viral (including CMV, HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-
- •CMV viral load will be assessed at screening and those with viremia will be excluded. Other 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
Duvelisib
Experimental
-Duvelisib 25 mg twice daily for up to 10 days.
干预措施: Duvelisib (Drug)
Duvelisib
Experimental
-Duvelisib 25 mg twice daily for up to 10 days.
干预措施: Peripheral blood draw (Procedure)
Placebo
Sham Comparator
-Placebo 25 mg twice daily for up to 10 days.
干预措施: Peripheral blood draw (Procedure)
Placebo
Sham Comparator
-Placebo 25 mg twice daily for up to 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival as Measured by Number of Participants Alive Through 28 Days
时间窗: Through 28 days
次要结局
- Length of ICU Stay(Through 28 days)
- Duration on Renal Replacement Therapy(Through 28 days)
- Number of Adverse Events as Measured by CTCAE v. 5.0(Through 29 days)
- Length of Hospital Stay(Through 28 days)
- Duration of Ventilator Use(Through 28 days)
- Duration of Vasopressors Use(Through 28 days)
- Viral Kinetics as Measured by Virologic Failure(Through 28 days)
研究者
研究点 (1)
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