CTRI/2020/08/027205进行中（未招募）2 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.
GlaxoSmithKline Research and Development Limited12 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2020年8月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 12
- 主要终点
- To compare the efficacy of otilimab IV versus placebo
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in addition to standard treatment of care in treatment of patients with severe pulmonary COVID-19 related disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥18 years and ≤79 years at the time of obtaining informed consent.
- •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 defined as SpO2 ≤90% on room air d.
- •AND requiring any of the following:
- •high-flow oxygen (≥15L/min)
- •non-invasive ventilation (e.g. CPAP, BiPAP)
- •mechanical ventilation ≤48h prior to dose e.
- •AND have increased biological markers of systemic inflammation (either CRP>ULN or serum ferritin >ULN).
- •No gender restriction.
- •Female participants must meet and agree to abide by the contraceptive criteria detailed in Appendix
- •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: o Is a woman of non-childbearing potential (WONCBP) as defined in Section 9.4: Contraceptive and Barrier Guidance.
- •OR o Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 9.4 during the study intervention period and for at least 60 days after the last dose of study intervention (sexual abstinence is acceptable if it is the participant’s normal practice).
- •o If not consistently on a highly effective method of contraception (Section 9.4) during hospitalization, the participant must agree to a highly effective contraception plan if discharged before Day
- •o The investigator should evaluate potential for contraceptive method failure (e.g. Noncompliance, recently initiated) in relation to the first dose of study intervention.
- •o A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at hospital admission or before the first dose of study intervention.
- •See Section 7.3.5 Pregnancy Testing (additional requirements for pregnancy testing during and after study intervention).
- •o The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Capable of giving written informed consent as described in Section 9.1.
- •If participants are not capable of giving written informed consent, alternative consent procedures will be followed as detailed in Section 9.1.3.
排除标准
- •Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
- •Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU.
- •Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose (>0.15mcg/kg/min) noradrenaline (or equivalent) or more than one vasopressor.
- •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 investigators judgment, precludes the participants safe participation in and completion of the study.
- •Untreated systemic bacterial, fungal, viral, or other infection (other than SARSCoV-2).
- •Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
- •Known HIV regardless of immunological status.
- •Known HBsAg and/or anti-HCV positive.
- •Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy.
- •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.
- •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.
- •Note: Participants with an organ transplant are therefore excluded (except patients with corneal transplants not requiring immunosuppression).
- •History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy.
- •Received COVID-19 convalescent plasma within 48 hours of randomization.
- •Note: Participants who have received COVID-19 convalescent plasma but continue to worsen in the 48 hours after infusion of the convalescent plasma, in the opinion of the investigator, will become eligible for the study.
- •Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition in a dose higher than prednisone 10 mg or equivalent per day.
- •Treatment with an investigational drug within 30 days of randomization.
- •Participating in other drug clinical trials, including for COVID-
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5x upper limit of normal (ULN).
- •Platelets <50,000/mm
- •Haemoglobin ≤9 g/dL.
- •Absolute neutrophil count (ANC) <1.5 x 10 raised to 9/L (neutropenia ≥ Grade 2).
- •Estimated GFR ≤30 mL/min/1.73meter square.
- •Pregnant or breastfeeding females.
结局指标
主要结局
To compare the efficacy of otilimab IV versus placebo
时间窗: Participants alive and free of respiratory failure at Day 28
次要结局
- To compare the efficacy of otilimab IV versus placebo(To compare the safety and tolerability of otilimab IV versus placebo)
研究者
研究点 (12)
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