Efficacy of Nicotine in Preventing COVID-19 Infection (NICOVID-PREV)

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 3

Conditions: SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Covid19

Treatments: Drug: Nicotine patch; Drug: Placebo patch

Study type: Interventional

Funder types: Other

Identifiers

NCT04583410

APHP200538

2020-003722-23 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 1,633 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 or over
2. May be followed for the duration of the study
3. Obtaining free, 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)

Exclusion criteria

1. Symptoms suggestive of COVID-19 on the day of inclusion or in the past 14 days

2. Documented history of COVID-19 and / or positive SARS-COV2 serology before the day of inclusion

3. Treatment ongoing with nicotine replacement therapy, varenicline or bupropion within 30 days before inclusion

4. Known addiction problem to alcohol (defined by AUDIT-C > or = 10) or other substances.

5. Vaccinated against COVID19 infection.

6. Contraindications for nicotine patches:

   • pregnant woman (negative pregnancy test on inclusion) or breastfeeding woman

   • lack of effective contraception for women of childbearing potential

   • Generalized skin conditions that can 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 angor

   • Severe cardiac arrhythmia (defined by wearing an automatic implantable defibrillator)

   • Obliterating peripheral arterial disease

   • Known severe heart failure

   • Known severe renal or hepatic impairment,

   • Pheochromocytoma

   • Uncontrolled hyperthyroidism

   • Esophagitis due to gastroesophageal reflux disease or active peptic ulcer

     7 Already included in an interventional trial evaluating a health product 8 Staff under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision 9 Do not have a smartphone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,633 participants in 2 patient groups, including a placebo group

Nicotine patch

Experimental group

Treatment:

Drug: Nicotine patch

Placebo patch

Placebo Comparator group

Treatment:

Drug: Placebo patch