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. According to current knowledge, there are no treatments that prevent the spread of the infection, especially in exposed populations, or the disease progression to a severe form. Daily active smokers are infrequent among outpatients or hospitalized patients with COVID-19. Several arguments suggest that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). Nicotine may inhibit the penetration and spread of the virus and have a prophylactic effect in COVID-19 infection. However, the epidemic is progressing throughout French territory and new variants (in particular the "English B1. 1.7 variant of SARS-COV-2") much more contagious run a risk of accelerating the epidemic in the population. The anti-SARS-COV-2 vaccines recently launched (or being evaluated) represent great hope in this health crisis, but trials were only able to show their effectiveness on symptomatic forms of SARS-COV-2 infection. On the one hand, the vaccination compaign for the entire population requires many months,which leaves many unprotected subjects waiting. In addition, there is currently no evidence of a protective role of vaccines against asymptomatic forms of COVID-19 and therefore on SARS-COV-2 transmission. Finally, the nicotine patches may protect people in hight-risk areas/periods until they are vaccinated (if they accept it and are eligible for it) and in the post-vaccination weeks necessary for the effectiveness of the vaccine,which reinforces the importance of evaluating this alternative prevention strategy, in the context of the arrival of vaccines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,633
NICOPATCHLIB, 7mg/24h Day 1 to day 3 : 3,5 mg/day Day 4 to day 9 : 7 mg/day Day 10 to Day 15 : 10,5 mg/day Day 16 to day 98 : 14 mg/day Decrease treatment Day 99 to day 105 : 10,5 mg/day Day 106 to day 112 : 7 mg/day Day 113 to Day 119 : 3,5 mg/day
PLACEBO OF NICOPATCHLIB, 7mg/24h Day 1 to day 3 : 3,5 mg/day Day 4 to day 9 : 7 mg/day Day 10 to Day 15 : 10,5 mg/day Day 16 to day 98 : 14 mg/day Decrease treatment Day 99 to day 105 : 10,5 mg/day Day 106 to day 112 : 7 mg/day Day 113 to Day 119 : 3,5 mg/day
Centre Hospitalier Gonesse
Gonesse, France
RECRUITINGGroupe Hospitalier de la Région de Mulhouse Sud Alsace
Mulhouse, France
NOT_YET_RECRUITINGHôpital Pitié Salpêtrière - Service de Médecine Interne
Paris, France
RECRUITINGHôpital Sainte-Anne
Paris, France
NOT_YET_RECRUITINGSARS-COV2 seroconversion between W0 and W19 after randomization
This is the proportion of subjects with at least one positive serology between W2 and W19. The time of S19 takes into account a seroconversion delay of 5 weeks in relation to the SARS-CoV2 contamination.
Time frame: Between week 0 and week 19
Proportion of documented symptomatic COVID-19 infection
Time frame: Week 8, Week16
SARS-COV2 seroconversion
This is the proportion of patients with at least one positive serology between W2 and W16.
Time frame: Week 16
Asymptomatic COVID-19 infection proportion at week 14
Asymptomatic COVID-19 infection is defined as SARS-CoV2 seroconversion at Week 19 without symptoms suggestive of COVID until the end of Week 16 to take in account of the two weeks of incubation period
Time frame: Week 14
Proportion of severe COVID-19 infection
documented infection (positive SARS-CoV2 PCR test and / or suggestive chest CT scan and / or seroconversion) whose first symptoms appeared before W8 and W16 respectively, and requiring hospitalization or home oxygen therapy, or having resulted in death
Time frame: Week 8, Week16
Number of sick leaves for a COVID-19 infection
Time frame: Week 16
Number of days off during sick leaves for a COVID-19 infection
Time frame: Week 16
Proportion of AE, SAE
Time frame: From inclusion and week 25
Intensity and frequency of nausea, dizziness, feeling of empty head, headache, vomiting
Time frame: Week 25
Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination
Time frame: Week 25
Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine
Time frame: Week 25
Mean score of Desire to smoke defined by French Tobacco Craving scale
Time frame: Week 25
Mean score of Withdrawal symptoms scale
Time frame: Week 25
Dosage of cotinine in the urine
Time frame: Week 8 and 25
Mean score of Fatigue Numeric rating scale
Time frame: Week 2, week 8, week 16
Weight
Time frame: Week 8, week 16, week 25
Mean score of Hospital anxiety and depression scale
Time frame: Week 2, week 8, week 16
Mean score of Insomnia severity scale
Time frame: Week 2, week 8, week 16
Positive and negative syndrome scale
Time frame: Week 2, week 8, week 16
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