Last updated: February 15, 2021
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting
Phase
3
Condition
N/ATreatment
N/AClinical Study ID
NCT04583410
APHP200538
2020-003722-23
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18 or over
- May be followed for the duration of the study
- Obtaining free, informed and signed consent
- Affiliated to a social security scheme or beneficiary of such a scheme (except AME)
- Non-smoker and non-vaping (for former smokers or vapers: abstinent for at least 12months)
Exclusion
Exclusion Criteria:
- Symptoms suggestive of COVID-19 on the day of inclusion or in the past 14 days
- Documented history of COVID-19 and / or positive SARS-COV2 serology before the day ofinclusion
- Treatment ongoing with nicotine replacement therapy, varenicline or bupropion within 30 days before inclusion
- Known addiction problem to alcohol (defined by AUDIT-C > or = 10) or other substances.
- Vaccinated against COVID19 infection.
- Contraindications for nicotine patches:
- pregnant woman (negative pregnancy test on inclusion) or breastfeeding woman
- lack of effective contraception for women of childbearing potential
- Generalized skin conditions that can interfere with the use of a transdermalpatch
- stroke or myocardial infarction or acute coronary syndrome for less than 3 months
- allergy to nicotine or to one of the excipients of the transdermal patch
- Uncontrolled high blood pressure
- Unstable or worsening angor
- Severe cardiac arrhythmia (defined by wearing an automatic implantabledefibrillator)
- Obliterating peripheral arterial disease
- Known severe heart failure
- Known severe renal or hepatic impairment,
- Pheochromocytoma
- Uncontrolled hyperthyroidism
- Esophagitis due to gastroesophageal reflux disease or active peptic ulcer 7 Already included in an interventional trial evaluating a health product 8 Staffunder guardianship or curatorship or deprived of their liberty by a judicial oradministrative decision 9 Do not have a smartphone
Study Design
Total Participants: 1633
Study Start date:
October 22, 2020
Estimated Completion Date:
June 30, 2022
Connect with a study center
Centre Hospitalier Gonesse
Gonesse, 95500
FranceActive - Recruiting
Groupe Hospitalier de la Région de Mulhouse Sud Alsace
Mulhouse, 68100
FranceSite Not Available
Hôpital Pitié Salpêtrière - Service de Médecine Interne
Paris, 75013
FranceActive - Recruiting
Hôpital Sainte-Anne
Paris, 75014
FranceSite Not Available
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