A Randomized Trial on Efficacy and Safety of Ozanimod for the Treatment of COVID-19 Patients Requiring Oxygen Support - A Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Daily Patient progression assessed with the World Health Organization-adapted 6-points ordinal scale
研究概览
简要总结
The virus SARS-CoV-2 causes severe pneumonia which, in a proportion of patients progresses towards an Acute Respiratory Distress Syndrome (ARDS) mainly related to the antiviral immune response. To date, there is no available treatment that significantly improves outcome of patients with COVID-19 pneumonia. Sphingosine-1-phosphate receptor 1 (S1P1) ligands control vascular leakage in the airways and sphingosine-1-phosphate (S1P) receptor ligands devoid of activity on sphingosine-1-phosphate receptor 3 (S1P3) show an excellent safety profile, including ozanimod. Critically, S1P1 ligands mildly impact, but do not compromise viral clearance and they reduced lung injury in preclinical models, even without concomitant use of antivirals and with a synergistic effect when associated to antiviral agents. Ozanimod was approved by the FDA for the treatment of relapsing multiple sclerosis at the end of March 2020, and was recently (October 2020) approved by Health Canada for the same indication. The investigators believe that this immune modulator is at the top of the list of agents that should be trialed in order to mitigate the morbidity and mortality of COVID-19.
The primary objective is to substantiate the impact of ozanimod on key outcomes of COVID-19 patient progression, which will guide decision making around sample size and the choice of endpoints for future clinical trial.
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 85 Years（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
Ozanimod + standard of care
During hospitalization, the experiment treatment of Ozanimod will be given with the standard of care (Recommendations for standard of care management of COVID-19 will be provided for anticoagulation, fluid resuscitation, corticoids and other immunomodulators, antipyretics agents, antiviral agents and other treatments. These recommendations are subject to modifications based on the new literature data.).
干预措施: Ozanimod (Drug)
Ozanimod + standard of care
During hospitalization, the experiment treatment of Ozanimod will be given with the standard of care (Recommendations for standard of care management of COVID-19 will be provided for anticoagulation, fluid resuscitation, corticoids and other immunomodulators, antipyretics agents, antiviral agents and other treatments. These recommendations are subject to modifications based on the new literature data.).
干预措施: Standard of care (Other)
Standard of care
During hospitalization, patient will be given standard of care (Recommendations for standard of care management of COVID-19 will be provided for anticoagulation, fluid resuscitation, corticoids and other immunomodulators, antipyretics agents, antiviral agents and other treatments. These recommendations are subject to modifications based on the new literature data).
干预措施: Standard of care (Other)
结局指标
主要结局
Daily Patient progression assessed with the World Health Organization-adapted 6-points ordinal scale
时间窗: through whole duration of the hospitalization, an average of 14 days
Clinical improvement until hospital discharge
次要结局
- Rate of non invasive ventilation (NIV) / high flow nasal therapy (HFNT) use(through whole duration of the hospitalization, an average of 14 days)
- The mean oxygen flow required to maintain the oxygen saturation (SpO2) target at 92%(First 7 days of the trial)
- Rate of intubation(through whole duration of the hospitalization, an average of 14 days)
- Ventilator-free and oxygen-free days at day 28(through whole duration of the hospitalization, an average of 14 days)
- Rate of ICU admission/length of stay/mortality(through whole duration of the hospitalization, an average of 14 days)
- Severity index measurement(through whole duration of the hospitalization, an average of 14 days)
研究者
François Lellouche
MD
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec