Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Time to clinical improvement
研究概览
简要总结
It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.
This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit.
The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments.
A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.
Patients will be randomly allocated 1:1 to either nivolumab or SoC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (men and women) age over 18 years old
- •At least one nasal swab positive for COVID-19 detected by PCR, maximum 7 days prior to treatment
- •Viral pneumonia confirmed by TDM scan
- •Patients meeting all of the following 3 criteria:
- •Requiring more than 3L/min of oxygen
- •WHO progression scale = 5
- •No NIV or High flow
排除标准
- •Patients with active cancer and immunocopromised patients
- •Known hypersensitivity to nivolumab or to any of their excipients.
- •Pregnancy
- •Patient with an autoimmune or inflammatory disease (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease). Patients with thyroiditis or vitiligo only could be included.
- •Patient with a history of thymoma
- •Patient with a history of solid organ transplantation or a bone marrow transplantation
- •Patients treated with immune checkpoint inhibitors 3 months prior to the study
- •Patients who had a history of grade 3 or 4 immune-related adverse events with a previous treatment with immune-checkpoint inhibtors
- •Patients requiring ICU based on Criteria of severity of COVID pneumopathy
- •Respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation
研究组 & 干预措施
Nivolumab
干预措施: Nivolumab Injection (Drug)
结局指标
主要结局
Time to clinical improvement
时间窗: day 14
the time required for clinical improvement, defined as the time elapsed between randomization and a two-point improvement on an ordinal scale with seven categories (WHO scale), or the discharge alive from hospital, whatever occurred first
次要结局
- Overall survival(day 90)
- Cumulative incidence of ICU admission(day 28)
- Length of hospital stay(day 90)
- Positive nasal PCR(day 7)
- Incidence of adverse events(day 28)
- Incidence of grade 3-4 adverse events(day 28)
- World Health Organisation (WHO) progression scale(day 4, 7 and 14)