A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Anti-viral Efficacy of Masitinib in Patients With Symptomatic Mild to Moderate COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- SARS-Cov-2 Viral Load at Day 10
研究概览
简要总结
The objective of the study is to evaluate the anti-viral efficacy of 3 different dosages of masitinib in patients with symptomatic mild to moderate COVID-19.
详细描述
The primary objective is to evaluate the virologic efficacy of masitinib plus Best Supportive Care (BSC), with respect to placebo plus BSC in reducing viral shedding of SARS-CoV-2 in patients with symptomatic mild to moderate COVID-19.
Patients will be randomized into one of the following treatment groups (all patients will receive BSC):
- Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo
- Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo
- Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 2 days then 6.0 mg/kg/day for 6 days versus corresponding placebo Treatments will be administered for 10 days and patients will be followed for 1 month. The treatment groups will be compared to pooled placebo after unblinding.
Regarding Best Supportive Care, for patients with a score of 2 and 3 (ambulatory) on the 10-score WHO clinical progression scale, Best Supportive Care is best available therapy in the country at the choice of the investigator excluding any antiviral treatment whether indirect (Ribavirin, Hydroxychloroquine or Chloroquine) or direct (anti-polymerase or antiprotease, including lopinavir/ritonavir fixed dose combination), other investigational treatments for SARS-CoV-2, plasma from a person who recovered from COVID-19, monoclonal antibody therapies and vaccine. For patients with a score of 4 and 5 (hospitalized) on the 10-score WHO clinical progression scale, Best Supportive Care is dexamethasone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female with: A. Symptomatic ambulatory male or non-pregnant female adult ≥ 18 years of age at time of enrolment with mild COVID-19 with score 2 or 3 of the 10-score WHO clinical progression scale OR B. Hospitalized male or non-pregnant female adult ≥ 18 years of age at time of enrolment with COVID-19 with score 4 or 5 of the 10-score WHO clinical progression scale.
- •Symptoms consistent with COVID-19, as determined by investigator, with onset ≤5 days before randomization
- •Positive test for COVID-19 ≤72 hours prior to randomization
- •Negative test for the IgG anti-SARS-CoV-2
排除标准
- •Any use of anti-viral medications up to 7 days before participating in the study
- •Receipt of plasma from a person who recovered from COVID-19 (convalescent plasma) any time before participating in the study
- •Receipt of last recommended dose of a SARS-CoV-2 vaccine up to 30 days before participating in the study
- •Receipt of a monoclonal antibodies up to 30 days before participating in the study.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Masitinib 3.0 mg/kg/day
Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo (all patients will receive Best Supportive Care)
干预措施: Masitinib Mesylate (Drug)
Masitinib 4.5 mg/kg/day
Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo (all patients will receive Best Supportive Care)
干预措施: Masitinib Mesylate (Drug)
Masitinib 6.0 mg/kg/day
Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 2 days then 6.0 mg/kg/day for 6 days versus corresponding placebo (all patients will receive Best Supportive Care)
干预措施: Masitinib Mesylate (Drug)
Placebo
Placebo arms associated with the three Experimental arms (all patients will receive Best Supportive Care) which will be pooled for analysis
干预措施: Placebo (Drug)
结局指标
主要结局
SARS-Cov-2 Viral Load at Day 10
时间窗: Baseline to Day 10
Time-weighted average change from baseline in viral shedding
次要结局
- SARS-Cov-2 Viral Load to post-baseline study days(Baseline up to Day 28)
- Time to negative RT-qPCR result(Baseline up to Day 28)