Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT04598594
Eligibility Criteria:
Inclusion Criteria:
1. Patient ≥ 18 years
2. Documented diagnosis of COVID 19 (according to the tests referenced on the list published on the website : https://covid-19.sante.gouv.fr.tests)
3. Hospitalized in intensive care unit, intubated and mechanically ventilated for less than 48 hours
4. Non-smoker and non-vaping or abstinent patient for at least 12 months
5. 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.
6. Affiliated to a social security scheme or beneficiary of such a scheme (AME excluded)
Exclusion Criteria:
1. Chronic respiratory failure defined by PaCO2\> 60 mmHg in ambulatory patients (respiratory parameters at baseline).
2. Mechanical ventilation at home (non-invasive mechanical ventilation or via a tracheostomy) with the exception of CPAP / BIPAP used only for sleep apnea syndromes
3. Predictable mechanical ventilation duration \<48 hours
4. Moribund patient or death expected on the day of randomization, or with a SAPS II score\> 90
5. Cerebral deficiency with dilated areactive pupils or irreversible neurological pathology.
6. Other concomitant severe pathology with an estimated life expectancy of less than 1 year
7. Treatment with nicotine replacement therapy or varenicline or bupropion ongoing
8. 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
9. Patient under guardianship or curatorship
10. Patient deprived of liberty by judicial or administrative decision
11. Patient included in another interventional trial evaluating a health product
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04598594
Study Brief:
Protocol Section:
NCT04598594