EUCTR2020-002677-95-IT进行中（未招募）1 期
Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2/3 Study, in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia -
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Adult male or female =18 to =80 years of age
- •2) Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray or CT scan
- •3) The patient requires, at baseline, high flow supplemental oxygen or CPAP, if high oxygen flow is not an available option
- •4) Patient agrees to use appropriate methods of contraception during the study and 3 months after the last dose of study drug
- •5) The patient or legal representative has signed a written informed consent approved by the IRB/Ethics Committee
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •1) Any co-morbidity that may add risk to the treatment in the judgement of the investigator.
- •2) Requiring intubation and mechanical ventilation
- •3) Oxygen saturation >95% on room air
- •4) Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
- •5) Patient is, in the investigator’s clinical judgement, unlikely to survive >72 hours
- •6) Pregnant (positive serum or urine test within 3 days prior to randomization) or nursing women
- •7) Unwillingness or inability to comply with procedures required in this protocol.
- •8) Corrected QT (QTc) interval on electrocardiogram (ECG) >470 ms for females or >450 ms for males, calculated using Friedericia’s formula (QTcF)
- •9) AST (SGOT) or ALT (SGPT) > 2.5 x upper limit of normal (ULN)
- •10) Total bilirubin >1.5x ULN (except where bilirubin increase is due to Gilbert’s Syndrome)
- •11) Serum creatinine >2.0 X ULN
- •12) Absolute neutrophil count <1000 cells/mm3
- •13) Platelet count <75,000/mm3
- •14) Hemoglobin <8.0 g/dL
- •15) Currently taking medications that are sensitive CYP3A4, CYP2C9 or CYP2C19 substrates and have a narrow therapeutic index
- •16) Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4
- •17) Currently taking warfarin, apixaban, argatroban or rivaroxaban due to drug-drug interaction based on CYP450 metabolism
- •18) Current drug or alcohol abuse
- •19) Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies
研究者
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