EUCTR2020-001759-42-BE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease. - OSCAR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,150
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. Age =18 years and =79 years at the time of obtaining informed consent.
- •2. Participants must:
- •a. have positive SARS-CoV-2 result (any validated test, e.g. RT-PCR [performed on an appropriate specimen; e.g. respiratory tract sample])
- •b. AND be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19)
- •c. AND be developing new onset of oxygenation impairment requiring any of the following
- •- high-flow oxygen (=15L/min)
- •- non-invasive ventilation (NIV, CPAP, BIPAP)
- •- mechanical ventilation =48h prior to dose
- •d. AND have increased biological markers of systemic inflammation (either CRP >ULN or serum ferritin >ULN).
- •3. No gender restriction.
- •4. Female participants must meet and agree to abide by the contraceptive criteria detailed in the protocol.
- •5. Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures will be followed.
- •1. Age 70 years or above at the time of obtaining informed consent.
- •2. Participants must:
- •a. have positive SARS-CoV-2 result (any validated test, e.g. RT-PCR [performed on an appropriate specimen; e.g. respiratory tract sample])
- •b. AND be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19)
- •c. AND be developing new onset of oxygenation impairment requiring any of the following
- •- high-flow oxygen (=15L/min)
- •- non-invasive ventilation (NIV, CPAP, BIPAP)
- •- mechanical ventilation =48h prior to dose
- •d. AND have increased biological markers of systemic inflammation (either CRP >ULN or serum ferritin >ULN).
- •3. No gender restriction
- •4. Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures will be followed.
- •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 440
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 710
排除标准
- •1. Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
- •2. Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU.
- •3. Extracorporeal membrane oxygenation (ECMO) haemofiltration/dialysis, or high-dose (>0.15 µg/kg/min) noradrenaline (or equivalent) or more than one vasopressor.
- •4. Current serious or uncontrolled medical condition (e.g. significant pulmonary disease [such as severe COPD or pulmonary fibrosis], heart failure [NYHA class III or higher], significant renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months) or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
- •5. Untreated systemic bacterial, fungal, viral, or other infection (other than SARS-CoV-2).
- •6. Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
- •7. Known HIV regardless of immunological status.
- •8. Known HBsAg and/or anti-HCV positive.
- •9. Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy.
- •10. Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin or planned to be received during the study.
- •11. Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors (e.g. baricitinib, tofacitinib, upadacitinib) within the last 3 months prior to randomization or planned to be received during the study.
- •12. History of allergic reaction, including anaphylaxis to any previous treatment with an anti- GM-CSF therapy.
- •13. Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition in a dose higher than prednisone 10 mg or equivalent per day.
- •14. Treatment with an investigational drug within 30 days of randomization.
- •15. Participating in other drug clinical trials, including for COVID-19.
- •16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5x upper limit of normal (ULN)
- •17. Platelets <50,000/mm3
- •18. Hemoglobin =9 g/L
- •19. Absolute neutrophil count (ANC) <1.5 x 109/L (neutropenia = Grade 2)
- •20. Estimated GFR =30 mL/min/1.73m2
- •21. Pregnant or breastfeeding females.
- •1. Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
- •2. Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU.
- •3. Extracorporeal membrane oxygenation (ECMO) haemofiltration/dialysis, or more than one inotrope/vasopressor of any class.
- •4. Current serious or uncontrolled medical condition (e.g. significant pulmonary disease [such as severe COPD or pulmonary fibrosis], heart failure [NYHA class III or higher], severe renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months), severe dementia, severe disability or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
- •5. Untreated systemic bacterial, fun
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