NICOVIDEvaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients
Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour
+ Placebo of NICOTINE Transdermal patch
COVID-19+7
+ Infecciones por Coronaviridae
+ Infecciones
Estudio de Tratamiento
Resumen
Fecha de inicio: 9 de diciembre de 2020
Fecha en la que se inscribió al primer participante.The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. To current knowledge, there is no treatment yet that that can prevent infection from SARS-COV-2 virus, nor the disease progression to a severe form. Daily active smokers are rare among outpatients or hospitalized COVID-19 patients. Several arguments suggest that nicotine could be responsible for this protective effect thank to the nicotinic acetylcholine receptor (nAChR). Based on epidemiological data and experimental data from scientific literature, we hypothesize that nicotine could inhibit the penetration and spread of the virus and improve the management of COVID19 , particularly in hospitalized patients to prevent adverse outcomes (death, transfer to intensive care unit, care limitation, mechanical ventilation an high flow oxygen).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 32 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Age ≥ 18 years * Patients hospitalized for less than 72 hours * Non-smoking and non-vaping patients (for former smokers or former vapers: abstinent for at least 12 months) * Documented diagnosis of COVID19 * Lung disease suggestive of COVID-19 on chest scanner or need for oxygen therapy * Obtaining, informed and signed consent * Affiliated to a social security scheme or beneficiary of such a scheme (except AME) Exclusion Criteria: * WHO 10-point Clinical Progression Scale score \> 5 (patient on non-invasive or mechanical ventilation, patient in need of high-flow oxygen therapy) * Indication of transfer to intensive care unit (oxygen therapy\> 8 L / min ; out or not carried out due to LATA) * Current treatment with nicotine replacement therapy, bupropion or varenicline in the last 30 days * Known addiction problem to alcohol or other substances * Contraindication for nicotine patches: * pregnant or breastfeeding woman * lack of effective contraception for women of childbearing age * Generalized skin pathologies that may interfere with the use of a transdermal patch * 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 angina * Severe cardiac arrhythmia (defined by wearing an automatic implantable defibrillator) * Known obliterating peripheral arterial disease * Known severe heart failure with an ejection fraction \<30%) * Known severe renal (ClCr \<30 ml / min) or hepatic (Child C) impairment * Known pheochromocytoma * Known uncontrolled hyperthyroidism * Esophagitis due to gastroesophageal reflux disease or an active peptic ulcer * Patient included in another interventional trial evaluating a health product * Patient under guardianship or curatorship * Patient deprived of liberty by judicial or administrative decision
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Hospital Pitié-Salpêtrière - AP-HP
Paris, FranceAbrir Hospital Pitié-Salpêtrière - AP-HP en Google Maps