CTRI/2020/09/027941已完成4 期
A multicentre, single arm, phase IV clinical trial to evaluate the safety and efficacy of Itolizumab for the treatment of cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) patients due to COVID 19.
Biocon Biologics India Limited17 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年9月26日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- Incidence, nature and severity of adverse events (severe acute infusion related reactions and higher) causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)
研究概览
简要总结
Thisis a Multi-Centre, single arm, phase IV clinical trial
The study described in this protocol is designed toevaluate safety and efficacy of Itolizumab in the post marketing setting. Thisstudy will be conducted as to provide additional safety data after use ofItolizumab intravenous infusion in the treatment of cytokine release syndrome(CRS) in moderate to severe acute respiratory distress syndrome patients due toCOVID 19 administered in clinical practice as per the prescribing information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female adults above >18 years
- •Informed consent for participation in the study
- •Confirmed virological diagnosis of SARS-CoV2 infection (RT-PCR)
- •Hospitalized with ARDS due to clinical worsening of COVID-19 infection
- •Oxygen saturation at rest in ambient air ≤94%
- •Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of ≤ 200
- •Baseline serum ferritin level ≥ 400 ng/mL and IL-6 levels greater than 3 times ULN, if known/available.
排除标准
- •Known severe allergic reactions to monoclonal antibodies
- •Active tuberculosis (TB) infection
- •History of inadequately treated tuberculosis or latent tuberculosis
- •In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments
- •Patient on invasive mechanical ventilator support
- •Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 6 months
- •Patient on treatment of anti-IL-6 as a part of supportive care
- •Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 9 Patients with known history of Hepatitis B, Hepatitis C or HIV.
结局指标
主要结局
Incidence, nature and severity of adverse events (severe acute infusion related reactions and higher) causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)
时间窗: Up to 1 month
次要结局
- Biomarkers (IL-6 and TNF-a)(up to 1 month)
- Change in inflammatory markers like CRP (C-reactive protein) level, Serum Ferritin, D- dimer and LDH(Up to 1 month)
- Duration of hospitalization(Up to 1 month)
- Remission of respiratory symptoms(time to independence from oxygen therapy in days)(Up to 1 month)
- One-month mortality rate(Up to 1 month)
- PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen) ratio(Up to 1 month)
- Remission of respiratory symptoms (time to independence from non-invasive mechanical ventilation calculated in days)(Up to 1 month)
- Proportion of patients without deterioration of lung function as measured by stable/ improved SpO2 without increasing FiO2(Up to 1 month)
- Clinical Status as improvement of 1 and 2 point on an ordinal scale(up to 1 month)
- Incidence, nature and severity of adverse events causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)(Up to 1 month)
研究者
研究点 (17)
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