A Multi-Centre, Open label, Two Arm Randomized, Pivotal Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- 1 one month mortality rate
研究概览
简要总结
This is a Multi-Centric, Open label, Two ArmRandomized, Pivotal Phase 2 Study.
All eligible patientsentering into the study will be randomized in 2:1 ratio to receive thetreatment A (Best supportive care + Itolizumab) / B (Best supportive care)respectively. Each patient will undergo the treatment based on their assignedtreatment for a month along with battery of tests that includes, but notlimited to, cytokines and chemokine, along with daily recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine;T.Bilirubin; morning Vitals –pulse, BP, RR; Temperature (highest temperature ofthe day),PaO2/FiO2, MAP, GCS.
As Itolizumab is aninvestigational drug, the benefit to COVID-19 patients experiencingcomplications such as Cytokine Release Syndrome is not known. However, findingsfrom this study may be beneficial to the society at a large at the National andInternational Level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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 (not tested in children yet)
- •Informed consent for participation in the study
- •Hospitalized due to clinical/instrumental diagnosis 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 or more than 25% detoriation from the immediate previous value.
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
- •Have received oral anti-rejection or immune-suppressive drugs within the past 6 months
- •Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
- •Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
- •Patients with known history of Hepatitis B, Hepatitis C or HIV
- •Absolute Neutrophils count (ANC) <1000 / mm3
- •Platelets <50,000 / mm3
- •Absolute Lymphocyte count (ALC): <500/mm3.
结局指标
主要结局
1 one month mortality rate
时间窗: up to One-month
• NIV
时间窗: up to One-month
• IMV
时间窗: up to One-month
5 Time of duration of mechanical ventilation, for pts needing intubation
时间窗: up to One-month
2 Proportion of pts with deterioration of lung function as measured by
时间窗: up to One-month
6 Change in inflammatory markers CRP, d-Dimer, ferritin
时间窗: up to One-month
• Stable SpO2; PaO2 without increasing FiO2
时间窗: up to One-month
4 Reduction in proportion of pts who need
时间窗: up to One-month
3 Reduction of endotracheal intubation rate, measured as rate of pts needing intubation
时间窗: up to One-month
• HFNO
时间窗: up to One-month
次要结局
- Biomarkers (IL-6, TNF-a)(up to One-month)
- PaO2 / FiO2 ratio(up to One-month)
- Treatment-related side effects as assessed by CTCAE(up to One-month)
- Radiological response(up to One-month)
- Duration of hospitalization(up to One-month)
- Lymphocyte count(up to One-month)
- Remission of respiratory symptoms(up to One-month)