CTRI/2020/05/024959已完成2 期
A Multi-Centre, Open label, Two Arm Randomized, Pivotal Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications
Biocon Biologics India Limited0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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. Male or female adults above 18 years (not tested in children yet)
- •2. Informed consent for participation in the study
- •3. Virological diagnosis of SARS-CoV2 infection (PCR)
- •4. Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection
- •5. Oxygen saturation at rest in ambient air <=94%
- •6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of < 200 or
- •more than 25% detoriation from the immediate previous value.
排除标准
- •1. Known severe allergic reactions to monoclonal antibodies
- •2. Active tuberculosis (TB) infection
- •3. History of inadequately treated tuberculosis or latent tuberculosis
- •4. In the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments
- •5. Have received oral anti-rejection or immune-suppressive drugs within the past 6 months
- •6. Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
- •7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
- •8. Patients with known history of Hepatitis B, Hepatitis C or HIV
- •9. Absolute Neutrophils count (ANC) <1000 / mm3
- •10. Platelets <50,000 / mm3
- •11. Absolute Lymphocyte count (ALC): <500/mm3
研究者
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