PER-108-20尚未招募未知
OPAGANIB, A SPHINGOSINE KINASE-2 (SK-2) INHIBITOR IN COVID-19 PNEUMONIA: A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN HOSPITALIZED ADULT SUBJECTS WITH SEVERE SARS-COV-PNEUMONIA- 2 POSITIVE
适应症
试验速览
- 阶段
- 未知
- 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. Adult men or women ≥18 to ≤80 years
- •2. Infection proven by COVID-19 by RT-PCR assay of a pharyngeal specimen (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest x-ray or CT that diagnosed COVID-19 pneumonia. Pharyngeal specimens collected at screening or within 7 days prior to screening are acceptable for the same ongoing COVID-19 pneumonia disease.
- •3. Patient requires, at baseline, supplemental high-flow oxygen or positive pressure ventilation, if high-flow oxygen is not an available option.
- •4. Male participants with female partners of childbearing potential accept one of the following appropriate contraceptive methods during the treatment period and for at least 1 month after the last dose of study drug:
- •Abstinence from penile-vaginal intercourse and agreeing to remain abstinent.
- •Male condom, with the female partner using a highly effective contraceptive method. (For more details on highly effective contraceptive methods, see Section 11.3).
- •Additionally, male participants must refrain from donating sperm during the study and for 1 month after the last dose of study drug.
- •Male participants with a pregnant or lactating partner must agree to abstain from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 month after the last dose of the penile drug. study.
- •Female participants:
- •A participant is eligible to participate if:
- •a) is not pregnant
- •b) not breastfeeding
- •c) is not a woman of childbearing age (WOCBP, as defined in Section 11.3)
- •d) is a WOCBP who agrees to consistently and correctly use a highly effective method of contraception during the treatment period and for at least 1 month after the last dose of study drug (see Section 11.3 for details).
- •5. The patient or legal representative has signed a written informed consent approved by the Ethics Committee / IRB
排除标准
- •1. Any comorbidity that may add risk to the treatment in the judgment of the investigator
- •2. Require intubation and mechanical ventilation in the baseline period
- •3. Patient has a Do not intubate and / or Do not resuscitate order present.
- •4. Oxygen saturation> 95% in ambient air
- •5. Any pre-existing respiratory condition requiring intermittent or continuous ambulatory oxygen prior to hospitalization.
- •6. If it is unlikely, based on the investigator´s clinical judgment, that the patient will survive> 72 hours
- •7. Pregnant women (positive urine or serum test within 3 days prior to randomization) or lactating women
- •8. Lack of will or inability to comply with the procedures required in this protocol
- •9. Corrected QT interval (QTc) on the electrocardiogram (ECG)> 470 ms for women or> 450 ms for men, calculated using Friedericia´s formula (QTcF)
- •10. AST (SGOT) or ALT (SGPT)> 5.0 x upper limit of normal (ULN)
- •11. Total bilirubin> 2.0 x ULN (except where increased bilirubin is due to Gilbert Syndrome)
- •12. Serum creatinine> 2.0 X ULN
- •13. Absolute neutrophil count <1000 cells / mm3
研究者
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