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

Last updated: June 21, 2021
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04598594
APHP200537
2020-003723-42
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient ≥ 18 years
  2. Documented diagnosis of COVID 19 (according to the tests referenced on the listpublished on the website : https://covid-19.sante.gouv.fr.tests)
  3. Hospitalized in intensive care unit, intubated and mechanically ventilated for lessthan 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 theabsence of a close/relative/trusted person, the patient may be included according tothe emergency procedure by the investigating doctor.
  6. Affiliated to a social security scheme or beneficiary of such a scheme (AME excluded)

Exclusion

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 atracheostomy) 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 IIscore> 90
  5. Cerebral deficiency with dilated areactive pupils or irreversible neurologicalpathology.
  6. Other concomitant severe pathology with an estimated life expectancy of less than 1year
  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 implantabledefibrillator)
  • Known severe heart failure (Defined, for this study, by systolic LV dysfunctionwith 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
  1. Patient under guardianship or curatorship
  2. Patient deprived of liberty by judicial or administrative decision
  3. Patient included in another interventional trial evaluating a health product

Study Design

Total Participants: 220
Study Start date:
November 06, 2020
Estimated Completion Date:
June 20, 2021

Connect with a study center

  • Centre Hospitalier Victor Dupouy - Service de Réanimation polyvalente et USC

    Argenteuil, 95100
    France

    Site Not Available

  • CHRU de Besançon - Service de Médecine Intensive Réanimation

    Besançon, 25030
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien - Service de réanimation

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • CHU Dijon - Hôpital François Miterrand Service de Médecine Intensive Réanimation

    Dijon, 22033
    France

    Site Not Available

  • Hôpital Simone VEIL - Service d'Anesthésie-Réanimation

    Eaubonne, 95000
    France

    Site Not Available

  • Grand Hôpital de l'Est Francilien - Site Jossigny - Réanimation

    Jossigny, 77600
    France

    Site Not Available

  • Hôpital Bicêtre - Service de Médecine Intensive Réanimation

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • Grand Hôpital de l'Est Francilien Site Meaux - Service de Réanimation Médico-Chirurgicale

    Meaux, 77104
    France

    Site Not Available

  • Groupement Hospitalier de la Région de Mulhouse Sud Alsace - Hop Emile MULLER

    Mulhouse, 68100
    France

    Site Not Available

  • CHU Nice - Hôpital L'Archet 1 - Service de Médecine Intensive Réanimation

    Nice, 06000
    France

    Site Not Available

  • CHR Orléans Service de Médecine Intensive Réanimation

    Orléans, 45067
    France

    Site Not Available

  • Hôpital Pitié Salpêtrière - ICU

    Paris, 75013
    France

    Site Not Available

  • Hôpital Pitié Salpêtrière - Intensive care unit

    Paris, 75013
    France

    Site Not Available

  • Hôpital Tenon - Service de Médecine Intensive Réanimation

    Paris, 75020
    France

    Site Not Available

  • Institut Mutualiste Montsouris Service de Réanimation Polyvalente

    Paris, 75014
    France

    Site Not Available

  • Centre Hospitalier René Dubos - Service de Réanimation Médico-Chirurgicale

    Pontoise, 95303
    France

    Site Not Available

  • Hôpital DELAFONTAINE Service de Médecine Intensive Réanimation

    Saint-Denis, 93200
    France

    Site Not Available

  • Médipôle Hôpital Privé - MHP Service de Médecine Intensive Réanimation

    Villeurbanne, 69100
    France

    Site Not Available

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