COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04598594

Assistance Publique - Hôpitaux de Paris

Not reported

2020-10-22

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 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)

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

2

Assistance Publique - Hôpitaux de Paris

18

100

France

Critical disease at enrollment

8: Critical disease at enrollment

220

Mortality

None

Phase 3

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 886, "treatment_name": "Nicotine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}]