NCT04830735撤回2 期
A Phase II Randomized Double-Blind Trial of Dasatinib Modulation of Hyperinflammation in Moderate and Severe Patients With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying
研究概览
简要总结
This phase II trial investigates how well dasatinib works in treating patients with moderate and severe COVID-19. Dasatinib is a drug used to treat chronic leukemia which may help reduce the strong inflammation caused by COVID-19 that can damage the lungs or other organs.
详细描述
PRIMARY OBJECTIVES:
I. To determine the proportion of patients requiring intubation/ventilator support, requiring rescue with tocilizumab, or dying.
II. To determine 1 month survival.
SECONDARY OBJECTIVES:
I. To estimate the safety and tolerability of dasatinib anhydrous (dasatinib) in the setting of COVID-19 infection.
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 (Participant, Investigator)
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
- •Patients must have laboratory test proven COVID19 and symptomatic disease requiring hospitalization: virological diagnosis of Sars-CoV2 infection (polymerase chain reaction [PCR]) within 14 days
- •Able to sign informed consent for participation in the study
- •Subject is hospitalized with one or more of the following:
- •Moderate disease: peripheral capillary oxygen saturation (SpO2) >= 93% on room air with one of the following risk factors for developing severe disease: age >= 60 years, history of hypertension, diabetes mellitus, cardiac disease, chronic lung disease, obesity (calculated body mass index [BMI] >= 30 kg/m^2), and cardiovascular disease, clinical and/or radiological evidence of chest involvement, CRP > 2X upper limit of normal, doubling of CRP in 24 hours where chest findings and CRP elevation not explained by other underlying disease.
- •After the first interim analysis, we may allow enrollment of severe disease COVID infected patients if safety and efficacy analysis appears favorable:
- •Severe disease:
- •Respiratory rate >= 30 breaths/ minute (min)
- •SpO2 < 93% while breathing room air
- •Partial pressure of oxygen measurement (PaO2)/fraction of inspired oxygen (FiO2) =< 300 mmHg
- •Absolute neutrophil count (ANC) > 1000 (baseline blood counts)
- •Platelets > 50,000 / mmc (baseline blood counts)
- •Alanine aminotransferase/aspartate aminotransferase (ALT/AST) < 5 times the upper limit of the normality
- •Total bilirubin < 3 x institutional upper limit of normal (IULN)
- •Creatinine < 2.5 times the upper limit of the normality
- •Azithromycin allowed but if on both drugs patient should be on constant cardiovascular (CV) monitoring
- •Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessment/procedures being conducted
- •Subject is willing and able to adhere to the study visit schedule and other protocol requirements
排除标准
- •Pleural effusion > grade 2 evident on chest x-ray (CXR) or chest computed tomography (CT)
- •Intubation/mechanical ventilation
- •Known hypersensitivity to dasatinib
- •Patient being treated with immunomodulators or anti-rejection drugs
- •Known active infections or other clinical condition that contraindicate dasatinib and cannot be treated or solved according to the judgement of the clinician
- •ALT/AST > 5 times the upper limit of the normality
- •Total bilirubin > 3 x IULN
- •Neutrophils < 1000 / mmc unless; platelets < 50,000 / mmc
研究组 & 干预措施
Arm I (dasatinib anhydrous)
Experimental
Patients receive dasatinib anhydrous PO QD for 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Dasatinib Anhydrous (Drug)
Arm II (placebo administration)
Placebo Comparator
Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo Administration (Drug)
结局指标
主要结局
Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying
时间窗: Up to 28 days
Outcome reported as the number of patients requiring mechanical ventilation, requiring tocilizumab or dying.
次要结局
- Absolute lymphocyte count(Baseline, during treatment (day 1-14) up to 1 month)
- CRP (C-reactive protein) level(Baseline, during treatment (day 1-14) up to 1 month)
- Change of the SOFA (Sequential Organ Failure Assessment)(Baseline, during treatment (day 1-14) up to 1 month)
- Number of participants with treatment-related side effects(During treatment and up to 30 days after the last treatment dose)
- Radiological response(Baseline (optional), after seven days and if clinically indicated(up to 1 month))
- Duration of hospitalization(From baseline up to patient's discharge (up to 1 month))
- Remission of respiratory symptoms(Up to 1 month)
研究者
研究点 (1)
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