NCT04355793No Longer Available不适用
An Open-Label Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 12 years of age or older.
- •Clinical diagnosis of COVID-19 and/or locally accepted positive test; if feasible, swab should be taken and saved for quantitative testing to determine viral load.
- •Disease severity making the patient eligible for hospitalization (whether or not hospitalization is available), with evidence of cytokine storm as determined by the treating physician. Manifestations of cytokine storm can include the following:
- •Severe shortness of breath (respiratory rate > 24 breaths/minute).
- •SpO2 of < 90% on ambient air.
- •Need for invasive or noninvasive mechanical ventilation.
- •Acute respiratory distress syndrome.
- •Multiple organ failure.
- •Be willing to avoid pregnancy or fathering children
- •Able to provide written informed consent, consent from the patient's legally authorized representative, and/or assent from the patient, parent, or guardian.
排除标准
- •Patients, patient's legally authorized representative, or legal guardians unable to review and sign ICF.
- •Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant.
- •Patients with inadequate liver function (ALT above 4 × ULN or direct bilirubin 4 × ULN and the laboratory abnormalities are considered to be due to underlying liver dysfunction).
- •Patients with platelet counts < 50 × 109 /L
- •Any underlying or current medical or psychiatric condition that, in the opinion of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the program.
- •Previous allergic reactions to JAK inhibitors or excipients.
- •Concomitant use of any other JAK inhibitor.
- •Is eligible or able to access ruxolitinib through an Incyte-sponsored clinical study or is eligible for another therapeutic clinical trial for cytokine storm at the treating institution..
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