Efficacy of Nicotine in Preventing COVID-19 Infection

Covid19 Clinical Trial

— NICOVID-PREV  

Official title:

Efficacy of Nicotine in Preventing COVID-19 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04583410
• Other study ID #: APHP200538
• Secondary ID: 2020-003722-23
• Status: Recruiting
• Phase: Phase 3
• Start date: October 22, 2020
• Est. completion date: June 2022

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Zahir AMOURA, MD
• Phone: +33142178244
• Email: zahir.amoura[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1633
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19
• Infection
• SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Nicotine patch
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
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

Locations

Country	Name	City	State
France	Centre Hospitalier Gonesse	Gonesse
France	Groupe Hospitalier de la Région de Mulhouse Sud Alsace	Mulhouse
France	Hôpital Pitié Salpêtrière - Service de Médecine Interne	Paris
France	Hôpital Sainte-Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of documented symptomatic COVID-19 infection		Week 8, Week16
Secondary	SARS-COV2 seroconversion	This is the proportion of patients with at least one positive serology between W2 and W16.	Week 16
Secondary	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	Week 14
Secondary	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	Week 8, Week16
Secondary	Number of sick leaves for a COVID-19 infection		Week 16
Secondary	Number of days off during sick leaves for a COVID-19 infection		Week 16
Secondary	Proportion of AE, SAE		From inclusion and week 25
Secondary	Intensity and frequency of nausea, dizziness, feeling of empty head, headache, vomiting		Week 25
Secondary	Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination		Week 25
Secondary	Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine		Week 25
Secondary	Mean score of Desire to smoke defined by French Tobacco Craving scale		Week 25
Secondary	Mean score of Withdrawal symptoms scale		Week 25
Secondary	Dosage of cotinine in the urine		Week 8 and 25
Secondary	Mean score of Fatigue Numeric rating scale		Week 2, week 8, week 16
Secondary	Weight		Week 8, week 16, week 25
Secondary	Mean score of Hospital anxiety and depression scale		Week 2, week 8, week 16
Secondary	Mean score of Insomnia severity scale		Week 2, week 8, week 16
Secondary	Positive and negative syndrome scale		Week 2, week 8, week 16