Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Intensive Care Unit Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2021-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19 SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nicotine patch

Group Type EXPERIMENTAL

Patch, Nicotine

Intervention Type DRUG

Two patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day

Placebo patch

Group Type PLACEBO_COMPARATOR

Patch, Placebo

Intervention Type DRUG

Two patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day

Interventions

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Patch, Nicotine

Two patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day

Intervention Type DRUG

Patch, Placebo

Two patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No