Efficacy of Nicotine in Preventing COVID-19 Infection

NCT04583410 | Unknown Phase 3 DMC

• 2 other identifiers: APHP2005382020-003722-23
• Study Type: interventional
• Target: 1,633
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

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

Keywords

Covid19; SARS-COV2; Preventing infection

Outcome Measures

Primary Outcomes (1)

• SARS-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.

  Between week 0 and week 19

Secondary Outcomes (18)

• Proportion of documented symptomatic COVID-19 infection

  Week 8, Week16

• SARS-COV2 seroconversion

  Week 16

• Asymptomatic COVID-19 infection proportion at week 14

  Week 14

• Proportion of severe COVID-19 infection

  Week 8, Week16

• Number of sick leaves for a COVID-19 infection

  Week 16

Study Arms (2)

Nicotine patch

EXPERIMENTAL

Drug: Nicotine patch

Placebo patch

PLACEBO COMPARATOR

Drug: Placebo patch

Interventions

Nicotine patch DRUG

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

Nicotine patch

Placebo patch DRUG

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

Placebo patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over
• May be followed for the duration of the study
• Obtaining free, informed and signed consent
• Affiliated to a social security scheme or beneficiary of such a scheme (except AME)
• Non-smoker and non-vaping (for former smokers or vapers: abstinent for at least 12 months)

You may not qualify if:

• Known addiction problem to alcohol (defined by AUDIT-C \> or = 10) or other substances.
• Vaccinated against COVID19 infection.
• Contraindications for nicotine patches:
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (4)

Centre Hospitalier Gonesse

Gonesse, 95500, France

RECRUITING

Groupe Hospitalier de la Région de Mulhouse Sud Alsace

Mulhouse, 68100, France

NOT YET RECRUITING

Hôpital Pitié Salpêtrière - Service de Médecine Interne

Paris, 75013, France

RECRUITING

Hôpital Sainte-Anne

Paris, 75014, France

NOT YET RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zahir AMOURA, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahir AMOURA, MD

CONTACT

+33142178244; zahir.amoura@aphp.fr

Florence TUBACH, MD

CONTACT

florence.tubach@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 12, 2020
• Study Start: October 22, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

FR (4)