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+9
+ Coronaviridae Infections
+ Infections
Treatment Study
Summary
Study start date: December 9, 2020
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Hospital Pitié-Salpêtrière - AP-HP
Paris, FranceOpen Hospital Pitié-Salpêtrière - AP-HP in Google Maps