A Multi-Centre, Open Label, Two Arm Randomized, 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
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Mean Change From Baseline D-Dimer
研究概览
简要总结
Randomized, Parallel Group, Active Controlled Trial
详细描述
This is a Multi-Centric, Open label, Two Arm Randomized, Phase 2 Study.
All eligible patients entering into the study will be randomized in 2:1 ratio to receive the treatment A (Best supportive care + Itolizumab) / B (Best supportive care) respectively. Each patient will undergo the treatment based on their assigned treatment for a month along with battery of tests that includes, but not limited to, cytokines and chemokine, along with recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals -pulse, BP, RR; Temperature, PaO2/FiO2, MAP, GCS.
As Itolizumab is an investigational drug, the benefit to COVID-19 patients experiencing complications such as Cytokine Release Syndrome is not known. However, findings from this study may be beneficial to the society at a large at the National and International Level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults above 18 years (not tested in children yet)
- •Informed consent for participation in the study
- •Virological diagnosis of SARS-CoV2 infection (PCR)
- •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
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
研究组 & 干预措施
Arm A - Itolizumab + BSC
干预措施: Itolizumab IV infusion (Drug)
Arm A - Itolizumab + BSC
干预措施: Best supportive care (BSC) (Drug)
Arm B - Best supportive care (BSC)
干预措施: Best supportive care (BSC) (Drug)
结局指标
主要结局
Mean Change From Baseline D-Dimer
时间窗: Day 7, Day 14, Day 21 & Day 30
Mean Change From Baseline in Ferritin
时间窗: Day 7, Day 14, Day 21 & Day 30
Mean Change from Baseline in Ferritin
One-month Mortality Rate Between the Two Arms
时间窗: One-month
1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
时间窗: Day 7, Day 14, Day 21 & Day 30
Stable SpO2: Defined as number of patients with absence of increase in FiO2 to maintain SpO2 ≥ 92% Improvement of SpO2: Defined as number of patients with decrease in FiO2 to maintain SpO2 \> 92%
Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)
时间窗: Day 30
Number of patients needing Intubation/IMV post treatment
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
时间窗: Day 7, Day14, Day 21 & Day30
Stable PaO2: Defined as number of patients with up to 10% change in PaO2/FiO2 ratio from baseline. Improvement of PaO2: Defined as number of patients with \> 10% improvement in PaO2/FiO2 ratio from baseline (including patients weaned off oxygen).
Reduction in Proportion of Patients- Invasive Mechanical Ventilation
时间窗: Day7, Day14, Day21 & Day 30
Patient improved from invasive ventilation over time from baseline.
Reduction in Proportion of Patients-High Flow Nasal Oxygen
时间窗: Day7 ,Day 14 ,Day 21, Day 30
Patient improved from High Flow Nasal Oxygen over time from baseline.
Reduction in Proportion of Patients on Non-invasive Ventilation
时间窗: Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30
Reduction in proportion of Patients on Non-invasive Ventilation: defined as number of patient improved and shifted to Face mask, Nasal cannula, non-rebreather mask or off oxygen over time
Mean Change From Baseline in CRP (C-reactive Protein)
时间窗: Day 7, Day 14, Day 21 & Day 30
Mean Change from Baseline in CRP
Mean Change From Baseline in LDH
时间窗: Day 7, Day14, Day 21 and Day 30.
Mean Change from Baseline in LDH
次要结局
- Biomarkers (IL-6, TNF-a)(Pre and Post 1st dose; Pre and Post 2nd dose)
- Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio)(Baseline, Day 7, Day 14, Day 21 & Day 30)
- Mean Change From Baseline of Absolute Lymphocyte Count(day 7, day 14 ,day 21 & day 30)
- Number and Percentage of Patients With Radiological Response(up to Day 30)