Efficacy of nicotine in preventing COVID-19 infection

Efficacy of nicotine in preventing COVID-19 infection - NICOVID-PREV

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003722-23-FR

Enrollment

1755

Registered

2020-08-04

Start date

2020-10-02

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital staff (medical and non-medical), with COVID19 negative diagnosis (SARS-CoV2 serology and SARS-Cov2 PCR) working in contact with COVID-19 positive patients. MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: NICOPATCHLIB 7 mg/24 heures, dispositif transdermique Product Name: NICOPATCHLIB 7 mg/24 heures Pharmaceutical Form: Cutaneous patch INN or Proposed INN: NICOTINE CAS Number: 54-11-5 Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Hospital staff in contact with patients a. doctors, nurses, caregivers, physiotherapists, stretcher bearers, radio manipulators, etc. b. active on the hospital site (not teleworking) for the duration of the study (health students are eligible if their internship covers the entire duration of the study) c. can be followed for the duration of the study 2. aged 18 or over 3. Obtaining informed and signed consent 4.Affiliated to a social security scheme or beneficiary of such a scheme (except AME) 5.non-smoker and non-vaping (for former smokers or vapers: abstinent for at least 12 months) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1668 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 87

Exclusion criteria

Exclusion criteria: • Symptoms suggestive of COVID-19 on the day of inclusion or in the past 21 days • Documented history of COVID-19 and / or positive SARS-COV2 serology before the day of inclusion • Treatment ongoing with nicotine replacement therapy, varenicline or bupropion • Known addiction problem to alcohol or other substances. • Contraindications for nicotine patches: o pregnant woman (negative pregnancy test on inclusion) or breastfeeding o lack of effective contraception for women of childbearing potential o stroke or myocardial infarction or acute coronary syndrome for less than 3 months o allergy to nicotine or to one of the excipients of the transdermal patch o Uncontrolled high blood pressure o Unstable or worsening angor o Severe cardiac arrhythmia (defined by wearing an automatic implantable defibrillator) o Obliterating peripheral arterial disease o Known severe heart failure o Known severe renal or hepatic impairment, o Pheochromocytoma o Uncontrolled hyperthyroidism o Esophagitis due to gastroesophageal reflux disease or active peptic ulcer • Already included in an interventional trial evaluating a health product • Staff under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of nicotine patches during 14 weeks in preventing symptomatic COVID-19 infection among medical and non-medical personnel in contact with patients;Secondary Objective: Evaluate the efficacy of nicotine in patches over 14 weeks (the measurement time for each of the outcome measures corresponds to SARS-CoV2 infections occurring between S2 and W16, taking into account the incubation period (14 days ) and the time between infection and seroconversion (5 weeks), in terms of: 1. symptomatic COVID-19 infections documented at W8 and W16 2. seroconversions (with or without symptomatic infection) at W16 and W19 weeks 3. Asymptomatic COVID-19 infections at W14 (documented by seroconversion at W19) 4. Severe COVID-19 infections at W8 and W16 weeks 5. Sick leave for COVID-19 infections whose symptoms occurred between W2 and W16 6.tolerance 7.Smoking rate vaping rate and at W25 8. neuropsychological impact at WS8, W16 and W25 9. want to smoke at W25 10. Withdrawal symptoms at W25 11. weight change under treatment and at W25 12. treatment compliance ;Primary end point(s): Temps jusqu’à infection symptomatique COVID-19 documentée (confirmée par un test PCR à SARS-CoV2 positif sur prélèvement naso-pharyngé ou crachat induit et/ou un scanner thoracique évocateur et/ou une séroconversion). L’effet du traitement sera évalué sur les infections cliniques survenant dans la période entre S0 et S14 soit pour tenir compte de 14 jours de période d’incubation, sur les symptômes entre S2 et S16 correspondant à des infections par le SARS-CoV2 survenues entre S0 et S14. ;Timepoint(s) of evaluation of this end point: From week 0 to week 16	—

Measure

Time frame

Main Objective: To assess the efficacy of nicotine patches during 14 weeks in preventing symptomatic COVID-19 infection among medical and non-medical personnel in contact with patients;Secondary Objective: Evaluate the efficacy of nicotine in patches over 14 weeks (the measurement time for each of the outcome measures corresponds to SARS-CoV2 infections occurring between S2 and W16, taking into account the incubation period (14 days ) and the time between infection and seroconversion (5 weeks), in terms of: 1. symptomatic COVID-19 infections documented at W8 and W16 2. seroconversions (with or without symptomatic infection) at W16 and W19 weeks 3. Asymptomatic COVID-19 infections at W14 (documented by seroconversion at W19) 4. Severe COVID-19 infections at W8 and W16 weeks 5. Sick leave for COVID-19 infections whose symptoms occurred between W2 and W16 6.tolerance 7.Smoking rate vaping rate and at W25 8. neuropsychological impact at WS8, W16 and W25 9. want to smoke at W25 10. Withdrawal symptoms at W25 11. weight change under treatment and at W25 12. treatment compliance ;Primary end point(s): Temps jusqu’à infection symptomatique COVID-19 documentée (confirmée par un test PCR à SARS-CoV2 positif sur prélèvement naso-pharyngé ou crachat induit et/ou un scanner thoracique évocateur et/ou une séroconversion). L’effet du traitement sera évalué sur les infections cliniques survenant dans la période entre S0 et S14 soit pour tenir compte de 14 jours de période d’incubation, sur les symptômes entre S2 et S16 correspondant à des infections par le SARS-CoV2 survenues entre S0 et S14. ;Timepoint(s) of evaluation of this end point: From week 0 to week 16

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Secondary

Measure	Time frame
Secondary end point(s): - Documented symptomatic COVID-19 infection (confirmed by a PCR test for SARS-CoV2 and / or a suggestive chest CT scan and / or seroconversion) whose first symptoms occurred between W2 and W8, and between W2 and W16 - SARS-COV2 seroconversion between inclusion visit and W16, between inclusion visit and W19 - Asymptomatic COVID-19 infection at W14: SARS-COV2 seroconversion between inclusion visit and W19 (to take into account the time to seroconversion) without suggestive symptoms of COVID between D0 and W14 - Severe COVID-19 infection: documented infection (positive SARS-CoV2 PCR test and / or suggestive chest CT scan and / or seroconversion) whose first symptoms appeared between W2 and W16, and requiring hospitalization or home oxygen therapy, or having resulted in death. - Number of sick leaves for a COVID-19 infection whose first symptoms appeared between W2 and W16 and number of days of sick leave for these infections - Tolerance: adverse events and serious adverse events - Intensity and frequency of nausea, dizziness, feeling of empty head, headache, vomiting during the treatment - Active smoker, active vapoteur, and / or taking nicotine substitutes at W25 (documented by examination and dosage of urinary cotinine) - Neuropsychological impact under treatment and W25 on the other hand:- Scale for measuring emotions (PANAS), scale for measuring anxiety and depression (HAD) and scale for symptoms of sleep disorders (ISI), scale for measuring post-traumatic stress disorder (IES-R) - Desire to smoke scale FTCQ12 at W25 - withdrawal symptoms scale (CWS) at W25 - Weight under treatment on the one hand and at W16 and W25 on the other hand - Compliance with treatment (premature discontinuation of treatment, modification of doses, etc.) - Dosage of cotinine in the urine measured at W8, to check the treatment taken in the experimental arm and the absence of nicotine taken in the control arm (the results of these dosages will not be reported during t	—

Measure

Time frame

Secondary end point(s): - Documented symptomatic COVID-19 infection (confirmed by a PCR test for SARS-CoV2 and / or a suggestive chest CT scan and / or seroconversion) whose first symptoms occurred between W2 and W8, and between W2 and W16 - SARS-COV2 seroconversion between inclusion visit and W16, between inclusion visit and W19 - Asymptomatic COVID-19 infection at W14: SARS-COV2 seroconversion between inclusion visit and W19 (to take into account the time to seroconversion) without suggestive symptoms of COVID between D0 and W14 - Severe COVID-19 infection: documented infection (positive SARS-CoV2 PCR test and / or suggestive chest CT scan and / or seroconversion) whose first symptoms appeared between W2 and W16, and requiring hospitalization or home oxygen therapy, or having resulted in death. - Number of sick leaves for a COVID-19 infection whose first symptoms appeared between W2 and W16 and number of days of sick leave for these infections - Tolerance: adverse events and serious adverse events - Intensity and frequency of nausea, dizziness, feeling of empty head, headache, vomiting during the treatment - Active smoker, active vapoteur, and / or taking nicotine substitutes at W25 (documented by examination and dosage of urinary cotinine) - Neuropsychological impact under treatment and W25 on the other hand:- Scale for measuring emotions (PANAS), scale for measuring anxiety and depression (HAD) and scale for symptoms of sleep disorders (ISI), scale for measuring post-traumatic stress disorder (IES-R) - Desire to smoke scale FTCQ12 at W25 - withdrawal symptoms scale (CWS) at W25 - Weight under treatment on the one hand and at W16 and W25 on the other hand - Compliance with treatment (premature discontinuation of treatment, modification of doses, etc.) - Dosage of cotinine in the urine measured at W8, to check the treatment taken in the experimental arm and the absence of nicotine taken in the control arm (the results of these dosages will not be reported during t

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Countries

France

Contacts

Public ContactPôle Promotion-DRCI

ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)

carla.vandenabele@aphp.fr+33140275727

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026