Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19: a Single-center, Observational Retrospective-prospective Comparative Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- Clinical evolution according the WHO Clinical Progression Scale
研究概览
简要总结
This is a Pilot study for evaluating the feasibility, security and efficacy of the use of Cypropheptadine, an antihistaminic and antiserotonin drug, as an adjunct of the standardized treatment in a population of patient who are hospitalized and requiring oxygen therapy for COVID-19.
详细描述
Background :
Biochemical studies have revealed a significant increase in plasma serotonin levels in patients suffering from COVID-19 multi-organ disease, which appears to be a consequence of platelet hyperreactivity and dysfunction.
Among the several potential therapeutic pathways available to modulate this serotonin dysregulation is the use of cyproheptadine, an Anti-serotonergic antihistamine that can potentially improve organ dysfunction related to elevated plasma serotonin levels.
The investigators hypothesize that treatment with cyproheptadine will improve clinical course in these patients.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Women and men aged 18 and over.
- •Requiring treatment for COVID 19 and whose clinical status corresponds to a score equal to or greater than 5 on the WHO Clinical Progression Scale.
- •For the prospective study, able to give informed consent.
- •Not presenting an exclusion criterion
排除标准
- •Pregnancy
- •Patients with pre-existing terminal condition with life expectancy < 6 months
- •Patient with clinically frailty according to a score of the clinical frailty scale equal or superior to 7
- •Patients with pre-existing severe lung disease requiring home oxygen therapy.
- •Patients with pre-existing severe hepatic cirrhosis (Grade C according to the Child-Pugh classification)
- •Patients with pre-existing kidney failure (GFR strictly less than 15ml/min/1.73m2 according The KDIGO classification) or requiring renal replacement therapy.
- •Patients with pre-existing angle-closure glaucoma
- •Patient with symptomatic prostatic hypertrophy or bladder neck obstruction
- •Patient with history of seizure disorder
- •Patient with history of adverse reaction to antihistamines or to Cyproheptadine
- •Patients taking routinely SSRI or monoamine oxidase inhibitor therapy.
- •Patients presenting severe hepatic cytolysis with ALP >5 ULN at the time of study inclusion.
研究组 & 干预措施
Cyproheptadine
干预措施: Cyproheptadine Hydrochloride 4 MG (Drug)
结局指标
主要结局
Clinical evolution according the WHO Clinical Progression Scale
时间窗: Approximately 28 days
World Health Organisation Clinical Progression Scale for COVID 19 Minimal value 0 (uninfected) to maximal value 10 (Dead)
次要结局
- C Reactive Protein level(Approximately 28 days)
- Total number of days of hospitalisation(Approximately 28 days)
- Total number of days of hospitalization in the ICU(Approximately 28 days)
- Total number of days of mechanical ventilation(Approximately 28 days)
- Daily ROX ratio(Approximately 28 days)
- Incidence of Treatment-Emergent Adverse Events(Approximately 28 days)
- Recruitement rate(6 month)
- Completion rate(6 month)
- Rate of Death from any cause(Approximately 28 days)
- Creatinine level(Approximately 28 days)
- Alanine amino transferase level(Approximately 28 days)
- D-Dimere level(Approximately 28 days)
- Platelet count(Approximately 28 days)