CTRI/2020/06/026228尚未招募2 期
A Phase II, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib with best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
- •2.Men and women >=18 years of age
- •3.SARS-CoV-2 confirmed per World Health Organization (WHO) criteria within 4 days of randomization.
- •4.COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen.
- •5.Able to swallow pills.
- •6.Willing to follow contraception guidelines
排除标准
- •COVID-19 Related Medical Conditions
- •1. Respiratory failure at the time of screening due to COVID-19 pneumonia.
- •2. Known medical resuscitation within 14 days of randomization.
- •3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigators judgment, precludes the subjects safe participation in and completion of the study
- •4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2).
- •5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- •Medical Conditions
- •6. Not expected to survive 28 days given their pre-existing, uncorrectable medical condition.
- •7. Pregnant or breast feeding.
- •8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin >= 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C).
- •9. Absolute neutrophil count (ANC) < 500/μL at screening (per local laboratory).
- •10. Platelet count < 50,000/μL at screening (per local laboratory).
- •11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) Ã? mass (kg)/(72 Ã? creatinine mg/dL) multiply by 0.85 if female].
- •12.Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4).
- •Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening area allowed to enrol on study.
- •13.History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease.
- •14.Quadriplegia.
- •15.History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization.
- •16.Known active hepatitis B or C infection requiring therapy.
- •Prior/Concomitant Therapy:
- •17.Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug).
- •18.Requires treatment with proton-pump inhibitors.
- •19.Received oral antirejection or immunomodulatory drugs.
- •20.Active participation in other drug clinical trials or received treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization/enrolment.
- •21.Subjects at randomization who require inhaled corticosteroids or maintenance doses of more than 7.5 mg of prednisone or equivalent per day.
- •22.Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of acalabrutinib.
- •23.History of hypersensitivity (ie, allergic response) to active or inactive excipients of acalabrutinib or other Btk inhibitors.
- •24.Known cytoreductive chemotherapy treatment within 14 days of randomization.
- •25.Major surgery (as defined by the Investigator) within 4 weeks prior to randomization or still recovering from prior surgery.
研究者
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