Cyproheptadine in Severe COVID-19 : A Unblinded Randomized Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 主要终点
- Length of hospitalization
研究概览
简要总结
This randomized controled open label clinical trial is to evaluate the effect of Cyproheptadine on the clinical course of patients presenting a severe SARS-COV 2 pneumonia.
详细描述
Observational and biochemical studies have identified an interesting pathway in the pathophysiology of certain clinical-biological characteristics of COVID-19, linked to an excess of serotonin. We hypothesize that the antagonism of the action of serotonin could improve the clinical course of patients most severely affected by COVID-19.
One such antagonist of serotonin with a long track record of safety and tolerability is cyproheptadine. Cyproheptadine acts as an antagonist of 5-hydroxytryptamine (5HT=serotonin) receptor subtype 2 as well as histamine-1 receptor. Many of the potent effects of serotonin on lung vascular tone, respiratory rate, and systemic vascular beds are mediated by 5-HT receptor subtype 2.
Investigators will randomize approximately 200 participants, aged 18 and older, who have tested positive for COVID-19 and who will be hospitalized at Santa Cabrini Hospital in Montreal, Quebec, Canada, presenting a severe form of covid-pneumonia-19 requiring supplemental oxygen.
Study eligibility of all participants will be assessed first. Once a participant is confirmed eligible and consented, they will participate in the study.
Participants will be randomly assigned (1: 1) to either take cyproheptadine 8 mg by mouth three times a day for 5 days and receive standard care or receive standard care alone.
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
- •Men and women age 18 or older
- •Hospitalized and requiring medical care for COVID-19
- •Presenting respiratory failure cause by COVID 19 requiring oxygen and/or mechanical ventilation support
- •With radiographic evidence of pulmonary infiltrate
- •Able to give informed consent or, if unable to do so regarding the medical condition, having relatives able of consenting for the patient
排除标准
- •Pregnancy
- •Patients with pre-existing terminal condition with life expectancy < 6 months
- •Patients with pre-existing severe lung disease requiring home O2
- •History of seizure disorder
- •History of adverse reaction to antihistamines or to Cyproheptadine
研究组 & 干预措施
Cyproheptadine and standard care
Start Cyproheptadine 8mg three times a day during 5 days. Dose will be reduced to 4mg three times a day if GFR inferior to 30ml/min/1.73m²
Standard management of COVID-19 infection according to current international guidelines
干预措施: Cyproheptadine Hydrochloride 4 MG (Drug)
结局指标
主要结局
Length of hospitalization
时间窗: Through study completion, an average of 1 year
Need mechanical ventilation (Non invasive or Invasive)
时间窗: Through study completion, an average of 1 year
次要结局
- Death(Day 28)
- Heart rate(At Day 1,3,5,7,10 after randomization)
- Duration of mechanical ventilation(Through study completion, an average of 1 year)
- Length of hospitalization in the intensive care unit(Through study completion, an average of 1 year)
- CRP level(At Day 1,3,5,7,10 after randomization)
- Platelet count(At Day 1,3,5,7,10 after randomization)
- SOFA Score(At Day 1,3,5,7,10 after randomization)
- Spo2/FiO2 and ROX ratio(At Day 1,3,5,7,10 after randomization)
- Respiratory Rate(At Day 1,3,5,7,10 after randomization)
- LDH level(At Day 1,3,5,7,10 after randomization)
- D-Dimere level(At Day 1,3,5,7,10 after randomization)