A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 12
- 主要终点
- 28-day survival rate
研究概览
简要总结
A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit.
According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts:
- COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1).
- COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Autophagy inhibitor (GNS651)
干预措施: Autophagy inhibitor (GNS651) (Drug)
Autophagy inhibitor (GNS651)
干预措施: Standard of care (Other)
Standard of care
干预措施: Standard of care (Other)
anti-NKG2A (Monalizumab)
干预措施: Standard of care (Other)
anti-NKG2A (Monalizumab)
干预措施: Monalizumab (Drug)
anti-C5aR (Avdoralimab)
干预措施: Standard of care (Other)
anti-C5aR (Avdoralimab)
干预措施: Avdoralimab (Drug)
结局指标
主要结局
28-day survival rate
时间窗: 28 days from randomization
28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. If vital status at 28 days post randomisation is not available due to early transfer in an external resuscitation unit, patients will be considered as failure at the date of the transfer. Comparison of each experimental arm (GNS561 then monalizumab for cohort1 and avdoralimab for cohort2) to control arm will be performed using a Fisher exact test.
次要结局
- Clinical status(Day 7, Day 14, Day 28)
- Length of stay in Intensive Care Unit(3 months (i.e. at the time of last patient last visit))
- Overall survival(3 months (i.e. at the time of last patient last visit))
- Rate of throat swab negativation(Day 7, Day 14, Day 28)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(3 months (i.e. at the time of last patient last visit))
- The rate of patients with SARS-CoV-2 IgG antibodies at D7, D14 and D28(Day 7, Day 14, Day 28)
- Mean change in the ranking of the NEWS2 score from baseline to D7, D14 and D28(Day 7, Day 14, Day 28)
- Biological parameters(3 months (i.e. at the the time of last patient last visit))
- Time to clinical improvement(28 days from randomization)
- Mean change in the ranking on the ordinal scale from baseline to D7, D14 and D28(Day 7, Day 14, Day 28)
- Duration of mechanical ventilation or high flow oxygen devices(3 months (i.e. at the time of last patient last visit))
- Quantitative SARS-CoV-2 virus in throat swab and blood samples(Day 7, Day 14, Day 28)
- The rate of secondary infection by other documented pathogens (bacteria, fungi)(Day 7, Day 14, Day 28 (if available))
- Duration of hospitalization(3 months (i.e. at the time of last patient last visit))
- Cost-Effectiveness Analyses (CEA)(3 months (i.e. at the time of last patient last visit))