NCT04598594已完成3 期
Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Intensive Care Unit Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 18
- 主要终点
- Mortality
研究概览
简要总结
There is currently no known treatment for COVID19. Active smokers are infrequent among patients with COVID-19 which has led our team to hypothesize that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). In fact, nAChR possess the ability to modulate ACE2 expression, the cellular doorway for SARS-CoV2. nAChR modulation by the virus would be responsible for the numerous clinical signs observed in COVID-19, including the cytokine storm manifested in intensive care hyperinflammatory patients.
Based on epidemiological data and experimental data from scientific literature, our team hypothesize that nicotine could inhibit the penetration and propagation of SARS-CoV2. Our team also claim that nicotine could attenuate the hyperinflammatory response and cytokine storm leading to acute respiratory failure and a probable multi-organ failure associated with COVID19.
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
- Double (Participant, Investigator)
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
- •Patient ≥ 18 years
- •Documented diagnosis of COVID 19 (according to the tests referenced on the list published on the website : https://covid-19.sante.gouv.fr.tests)
- •Hospitalized in intensive care unit, intubated and mechanically ventilated for less than 48 hours
- •Non-smoker and non-vaping or abstinent patient for at least 12 months
- •Obtain written informed consent from a relative / relative / support person. In the absence of a close/relative/trusted person, the patient may be included according to the emergency procedure by the investigating doctor.
- •Affiliated to a social security scheme or beneficiary of such a scheme (AME excluded)
排除标准
- •Chronic respiratory failure defined by PaCO2> 60 mmHg in ambulatory patients (respiratory parameters at baseline).
- •Mechanical ventilation at home (non-invasive mechanical ventilation or via a tracheostomy) with the exception of CPAP / BIPAP used only for sleep apnea syndromes
- •Predictable mechanical ventilation duration <48 hours
- •Moribund patient or death expected on the day of randomization, or with a SAPS II score> 90
- •Cerebral deficiency with dilated areactive pupils or irreversible neurological pathology.
- •Other concomitant severe pathology with an estimated life expectancy of less than 1 year
- •Treatment with nicotine replacement therapy or varenicline or bupropion ongoing
- •Contraindication for nicotine patches:
- •Pregnant or breastfeeding women
- •Allergy to nicotine or to one of the excipients of the transdermal patch
- •Generalized skin pathologies
- •Cerebrovascular accident or acute coronary syndrome for less than 3 months
- •Pheochromocytoma
- •Unstable or worsening angor
- •Severe cardiac arrhythmia (Defined by wearing an automatic implantable defibrillator)
- •Known severe heart failure (Defined, for this study, by systolic LV dysfunction with an LV ejection fraction (LVEF) of less than 30%)
- •Severe renal failure (Defined by KDIGO stage 3)
- •Severe hepatic impairment (Defined by a factor V <30%)
- •Arteriopathy obliterating of the lower limbs stage III and IV
- •Uncontrolled hyperthyroidism
- •Gastroduodenal esophagitis or ulcer undergoing treatment or active
- •Patient under guardianship or curatorship
- •Patient deprived of liberty by judicial or administrative decision
- •Patient included in another interventional trial evaluating a health product
研究组 & 干预措施
Nicotine patch
Experimental
干预措施: Patch, Nicotine (Drug)
Placebo patch
Placebo Comparator
干预措施: Patch, Placebo (Drug)
结局指标
主要结局
Mortality
时间窗: Day 28
次要结局
- Mortality(Day 60)
- Composite score incorporating death and the number of days living without mechanical ventilation(Day 60)
- Mean evolution of blood gases(Day 1 to Day 14)
- Mean evolution of Tidal Volume (ventilator parameters)(Day 1 to Day 14)
- Mean evolution of respiratory rate (ventilator parameters)(Day 1 to Day 14)
- Mean evolution of plateau pressure (ventilator parameters)(Day 1 to Day 14)
- Number of days alive and out of the ICU and hospital(Day 28, day 60)
- Mean score of Desire to smoke defined by French Tobacco Craving scale(2 weeks after treatment decrease, 8 weeks after treatment decrease)
- Mean score of Withdrawal symptoms scale(2 weeks after treatment decrease, 8 weeks after treatment decrease)
- Time before successful extubation(Day 60)
- Number of days living without invasive mechanical ventilation(Day 28)
- Mean evolution of Positive Expiratory Pressure (ventilator parameters)(Day 1 to Day 14)
- Mean evolution of fraction of inspired oxygen (ventilator parameters)(Day 1 to Day 14)
- Evolution of the Sequential Organ Failure Assessment (SOFA) score and its components by organ(Day 1 to Day 28)
- Number of days alive without organ failure(Day 28, day 60)
- Duration of hospitalization in intensive care unit(From day 1 up to 3 months)
- Duration of hospitalization in hospital(From day 1 up to 3 months)
- Evolution of viral load(Day 7, Day 14 or day of ICU discharge if before day 14)
- Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination(2 weeks after treatment decrease, 8 weeks after treatment decrease)
- Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine(2 weeks after treatment decrease, 8 weeks after treatment decrease)
- Mean score of Hospital anxiety and depression scale(2 weeks after treatment decrease, 8 weeks after treatment decrease)
- Post traumatic stress disorder scale(2 weeks after treatment decrease, 8 weeks after treatment decrease)
- Mean score of Insomnia severity scale(2 weeks after treatment decrease)
- Cotinin rate in blood(8 weeks after treatment decrease)
研究者
研究点 (18)
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