NCT05371275撤回2 期
Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation
biotx.ai GmbH1 个研究点 分布在 1 个国家开始时间: 2022年4月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment
研究概览
简要总结
This is a one-site, interventional, prospective, single-arm, open-label, controlled phase-IIa trial evaluating the safety and efficacy of palbociclib in hospitalized, moderate COVID- 19 cases.
详细描述
The study will include hospitalized, moderate COVID-19 cases that have a risk of respiratory failure.
The study will generally consist of:
- A short screening phase (1 day) before enrollment and thus treatment decision.
- A 21 day treatment phase with one "cycle" of palbociclib
- An up to day 90 Safety Follow-Up Phase
The first three patients will be enrolled and treated one by one; the independent safety data review committee (ISRC) will review each patient after D21 before enrollment of the subsequent patient is permitted.
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
- •age >= 18 years
- •positive PCR COVID-19 test (max. 72h old)
- •known vaccination status
- •ANC >= 1,000/mm3 and platelets >= 50,000/mm3
- •willingness to participate (written informed consent)
- •established risk factors for a severe course of COVID-19-disease, for example: adipositas, cardiovascular disease including arterial hypertension, advanced age > 60, chronic lung disease including asthma, diabetis type I or II, chronic kidney disease, chronic liver disease
- •Oxygen supply: ≤ 2 liters/minute
- •Women of childbearing potential (WOCBP): must have a negative pregnancy test (ß- HCG urine or serum test) a. WOCBP is considered as i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile.
- •b. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •c. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •Use of highly effective contraception method
- •All potentially fertile participants, or their male partners, must use an adequate, medically approved method of contraception or agree to abstinence during and at least 3 weeks (females) and 14 weeks (males) after treatment with Palbociclib.
- •For females, highly effective birth control should be used, i.e., combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, or intrauterine hormone-releasing system, bilateral tubal occlusion and vasectomized partner. As there is no information available on the interaction of palbociclib with oral contraceptives, a double-barrier contraception is necessary in this case.
- •Males must agree to use a condom for at least 14 weeks after the treatment phase.
排除标准
- •age < 18 year
- •ANC < 1,000/mm3 and platelets < 50,000/mm3
- •intensive care patient
- •treatment with any other CDK4/6 Inhibitor
- •pregnant or breast-feeding women
- •patients receiving immunosuppressants for other diseases (e.g. rheumatoid arthritis)
- •known malignancy in the past 5 years other than basal cell carcinoma
- •baseline O2-Saturation < 92%
- •participation in any other medical device or medicinal product study within the previous month
研究组 & 干预措施
Palbociclib
Experimental
125 mg of palbociclib once daily for 21 consecutive days
干预措施: Palbociclib (Drug)
结局指标
主要结局
Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment
时间窗: 21 days
次要结局
- Time to transfer to ICU(90 days)
- Rate of (S)AEs at day 21(at day 21)
- Course of D-dimer during treatment(21 days)
- Rate of persisting symptoms after 3, 6, 9 and 12 months(Through completion of safety follow-up up to 12 month)
- Time to freedom from oxygenation, measured in days after the first treatment dose.(90 days)
- Course of neutrophil cell count during treatment(21 days)
- Rate of thrombotic events during treatment(21 days)
- Course of O2 saturation during treatment(21 days)
- Dose reduction rate(21 days)
研究者
研究点 (1)
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