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    Summary
    EudraCT Number:2020-003722-23
    Sponsor's Protocol Code Number:APHP200538
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-003722-23
    A.3Full title of the trial
    Efficacy of nicotine in preventing COVID-19 infection
    Efficacité de la nicotine en prévention de l’infection COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of nicotine in preventing COVID-19 infection
    Efficacité de la nicotine en prévention de l’infection COVID-19
    A.3.2Name or abbreviated title of the trial where available
    NICOVID-PREV
    NICOVID-PREV
    A.4.1Sponsor's protocol code numberAPHP200538
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointPôle Promotion-DRCI
    B.5.3 Address:
    B.5.3.1Street AddressDRCI - Hôpital St Louis, 1 av Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+33140275727
    B.5.5Fax number+33144841701
    B.5.6E-mailcarla.vandenabele@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NICOPATCHLIB 7 mg/24 heures, dispositif transdermique
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNICOPATCHLIB 7 mg/24 heures
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNICOTINE
    D.3.9.1CAS number 54-11-5
    D.3.9.3Other descriptive nameNICOTINE
    D.3.9.4EV Substance CodeSUB14645MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.875
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    Personnel (médical et non médical) des hôpitaux, avec diagnostic COVID19 négatif (sérologie SARS-CoV2 et PCR SARS-Cov2) travaillant en contact avec les patients COVID-19 positifs.
    E.1.1.1Medical condition in easily understood language
    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.
    Personnel (médical et non médical) des hôpitaux, avec diagnostic COVID19 négatif (sérologie SARS-CoV2 et PCR SARS-Cov2) travaillant en contact avec les patients COVID-19 positifs.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    Évaluer l’efficacité de la nicotine en patchs pendant 14 semaines en termes de prévention de l’infection COVID-19 symptomatique parmi le personnel médical et non médical au contact de patients
    E.2.2Secondary objectives of the trial
    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
    Évaluer l’efficacité de la nicotine en patchs sur 14 semaines (le temps de mesure de chacun des critères de jugement correspond à des infections par le SARS-CoV2 survenues entre S2 et S16, en tenant compte de la période d’incubation (14 jours) et du délai entre l’infection et la séroconversion (5 semaines), en termes :
    1. d’infections symptomatiques COVID-19 documentées à 8 et 16 semaines
    2. de séroconversions (avec ou sans infection symptomatique) à 16 et 19 semaines
    3. d’infections COVID-19 asymptomatiques à 14 semaines (documentées par une séroconversion à 19 semaines)
    4. d’infections COVID-19 sévères à 8 et 16 semaines
    5. d’arrêts de travail pour COVID-19 pour des infections dont les symptômes sont survenus entre S2 et S16
    6. de tolérance
    7. de taux de fumeurs et taux de vapoteurs S25
    8. d’impact neuropsychologique à S8, S16 et S25
    9. d’envie de fumer à S25
    10. de symptômes de sevrage à S25
    11. d’évolution pondérale sous traitement et à S25
    12. d’observance du traitement
    E.2.3Trial contains a sub-study No
    E.3Principal 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)
    1. Personnel des hôpitaux au contact de patients
    a. médecins, infirmiers, aide soignants, kinésithérapeutes, brancardiers, manipulateurs radio, …
    b. en activité sur le site hospitalier (pas en télétravail) pendant la durée de l’étude (les étudiants en santé sont éligibles si leur stage couvre l’ensemble de la durée de l’étude)
    c. pouvant être suivi pendant la durée de l’étude
    2. âgé de 18 ans ou plus
    3. Obtention du consentement libre, éclairé et signé
    4. Affilié à un régime de sécurité social ou bénéficiaire d’un tel régime (sauf AME)
    5. non-fumeur et non-vapoteur (pour les anciens fumeurs ou vapoteurs : abstinent depuis au moins 12 mois)
    E.4Principal 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
    • Symptômes évocateurs de COVID-19 le jour de l’inclusion ou dans les 21 derniers jours
    • Antécédent de COVID-19 documenté et/ou sérologie SARS-COV2 positive avant le jour de l’inclusion
    • Traitement en cours par substituts nicotiniques, varénicline ou bupropion
    • Problème de dépendance connue à l’alcool ou à d’autres substances.
    • Contre-indications pour les patchs de nicotine:
    o femme enceinte (test de grossesse négatif à l'inclusion) ou allaitante
    o absence de contraception efficace pour les femmes en âge de procréer
    o accident vasculaire cérébral ou infarctus du myocarde ou syndrome coronaire aigu depuis moins de 3 mois
    o allergie à la nicotine ou à l’un des excipients du dispositif transdermique
    o Hypertension artérielle non contrôlée
    o Angor instable ou s’aggravant
    o Arythmie cardiaque sévère (définie par le port d’un défibrillateur automatique implantable)
    o Artériopathie périphérique oblitérante
    o Insuffisance cardiaque sévère connue
    o Insuffisance rénale ou hépatique sévère connue,
    o Phéochromocytome
    o Hyperthyroïdie non contrôlée
    o Œsophagite sur reflux gastro-œsophagien ou ulcère gastroduodénal actif
    • Déjà inclus dans une étude interventionnelle évaluant un produit de santé
    • Personnel sous tutelle ou curatelle ou privé de liberté par une décision judiciaire ou administrative
    E.5 End points
    E.5.1Primary 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.
    Time to documented symptomatic COVID-19 infection (confirmed by a positive SARS-CoV2 PCR test on nasopharyngeal swab or induced sputum and / or a suggestive chest CT scan and / or seroconversion).The effect of the treatment will be evaluated on clinical infections occurring in the period between W0 and W14, to take into account the 14-day incubation period, on the symptoms between S2 and W16 corresponding to infections by SARS-CoV2 occurring between W0 and WS14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From week 0 to week 16
    A partir de la semaine 0 et jusqu'à la semaine 25
    E.5.2Secondary 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 the follow-up so as not to rise blindly)
    - Infection symptomatique COVID-19 documentée (confirmée par un test PCR à SARS-CoV2 et/ou un scanner thoracique évocateur et/ou une séroconversion) dont les premiers symptômes sont survenus entre S2 et S8, et entre S2 et S16
    - Séroconversion SARS-COV2 entre l’inclusion et S16, entre l’inclusion et S19
    - Infection COVID-19 asymptomatique à S14 : séroconversion SARS-COV2 entre l’inclusion et S19 (pour tenir compte du délai de séroconversion) sans symptômes évocateurs de COVID entre J0 et S14
    - Infection COVID-19 sévères : infection documentée (test PCR à SARS-CoV2 positif et/ou scanner thoracique évocateur et/ou séroconversion) dont les premiers symptômes sont apparus entre S2 et S16, et ayant nécessité une hospitalisation ou une oxygénothérapie à domicile, ou ayant entrainé un décès.
    - Nombre d’arrêts de travail pour une infection COVID-19 dont les premiers symptômes sont apparus entre S2 et S16 et nombre de jours d’arrêt de travail pour ces infections
    - Tolérance : évènements indésirables et évènements indésirables graves
    - Intensité et fréquence des nausées, sensation d’étourdissement, sensation de tête vide, céphalées, vomissements pendant la durée de traitement
    - Fumeur actif, vapoteur actif, et/ou prise de substituts nicotiniques à S25 (documenté par l’interrogatoire et dosage de cotinine urinaire)
    - Impact neuropsychologique sous traitement et S25 d’autre part : échelle de mesure des émotions (PANAS), échelle de mesure de l’anxiété et la dépression (HAD) et échelle des symptômes des troubles du sommeil (ISI), échelle de mesure du syndrome de stress post-traumatique (IES-R)
    - Échelle d’envie de fumer FTCQ12 à S25
    - Échelle de symptômes de sevrage CWS à S25
    - Poids sous traitement d’une part et à S16 et S25 d’autre part
    - Observance du traitement (arrêt du traitement prématuré, modification de doses, …)
    - Dosage de cotinine dans les urines mesurée à S8, pour vérifier la prise de traitement dans le bras expérimental et l’absence de prise de nicotine dans le bras contrôle (les résultats de ces dosages ne seront pas rendus lors du suivi pour ne pas lever l’insu)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From week 0 to week 25
    A partir de la semaine 0 et jusqu'à la semaine 25
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Visit of the Last Subject
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1668
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 87
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    prophylaxis in hospital staff (medical and non-medical)
    prophylaxie chez le personnel (médical et non médical) des hôpitaux
    F.4 Planned number of subjects to be included
    F.4.1In the member state1755
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-01
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