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

The safety and scientific validity of this study is the responsibility of the
study sponsor and investigators. Listing a study does not mean it has been
evaluated by the U.S. Federal Government. Know the risks and potential
benefits of clinical studies and talk to your health care provider before
participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04583410

Recruitment Status  : Recruiting

First Posted  : October 12, 2020
Last Update Posted  : February 17, 2021

See Contacts and Locations

Sponsor:
Assistance Publique - Hôpitaux de Paris

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Details Tabular View No Results Posted Disclaimer

How to Read a Study Record

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Study Description Go to

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

Intervention/treatment Phase
Condition or disease 
 

Covid19 Drug: Nicotine patch Phase 3

SARS-Associated Coronavirus as Cause Drug: Placebo patch

of Disease Classified Elsewhere

Study Design Go to

Study Type  : Interventional (Clinical Trial)

Estimated Enrollment  : 1633 participants

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Nicotine in Preventing COVID-19 Infection
Actual Study Start Date  : October 22, 2020
Estimated Primary Completion Date  : December 2021
Estimated Study Completion Date  : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics:

COVID-19 (Coronavirus Disease 2019)

Drug Information available for: Nicotine tartrate Nicotine polacrilex

Genetic and Rare Diseases Information Center resources:

Severe Acute Respiratory Syndrome

U.S. FDA Resources

Arms and Interventions Go to

Arm  Intervention/treatment 

Experimental: Nicotine patch 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 Comparator: Placebo patch Drug: 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

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Arm  Intervention/treatment 

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

Outcome Measures Go to

Primary Outcome Measures  :

1. SARS-COV2 seroconversion between W0 and W19 after randomization

[ Time Frame: Between week 0 and week 19 ]

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.

Secondary Outcome Measures  :

1. Proportion of documented symptomatic COVID-19 infection [ Time Frame: Week 8,

Week16 ]
2. SARS-COV2 seroconversion [ Time Frame: Week 16 ]

This is the proportion of patients with at least one positive serology between W2 and
W16.

3. Asymptomatic COVID-19 infection proportion at week 14 [ Time Frame: 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

4. Proportion of severe COVID-19 infection [ Time Frame: Week 8, Week16 ]

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

5. Number of sick leaves for a COVID-19 infection [ Time Frame: Week 16 ]

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6. Number of days off during sick leaves for a COVID-19 infection [ Time Frame: Week
16 ]
7. Proportion of AE, SAE [ Time Frame: From inclusion and week 25 ]
8. Intensity and frequency of nausea, dizziness, feeling of empty head, headache,
vomiting [ Time Frame: Week 25 ]
9. Proportion of active smoker or active vapers or taking nicotine substitutes documented
by examination [ Time Frame: Week 25 ]
10. Proportion of active smoker or active vapers or taking nicotine substitutes documented
by urinary cotinine [ Time Frame: Week 25 ]
11. Mean score of Desire to smoke defined by French Tobacco Craving scale
[ Time Frame: Week 25 ]
12. Mean score of Withdrawal symptoms scale [ Time Frame: Week 25 ]
13. Dosage of cotinine in the urine [ Time Frame: Week 8 and 25 ]
14. Mean score of Fatigue Numeric rating scale [ Time Frame: Week 2, week 8, week 16 ]
15. Weight [ Time Frame: Week 8, week 16, week 25 ]
16. Mean score of Hospital anxiety and depression scale [ Time Frame: Week 2, week 8,
week 16 ]
17. Mean score of Insomnia severity scale [ Time Frame: Week 2, week 8, week 16 ]
18. Positive and negative syndrome scale [ Time Frame: Week 2, week 8, week 16 ]

Eligibility Criteria Go to

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk

with your doctor and family members or friends about deciding to join a
study. To learn more about this study, you or your doctor may contact the
study research staff using the contacts provided below. For general
information, Learn About Clinical Studies.

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

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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

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decision 9 Do not have a smartphone

Contacts and Locations Go to

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the
study research staff using the contact information provided by the
sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT

number): NCT04583410

Contacts

Contact: Zahir AMOURA, MD +33142178244 [email protected]

Contact: Florence TUBACH, MD [email protected]

Locations

France

Centre Hospitalier Gonesse Recruiting

Gonesse, France, 95500

Contact: Isabelle AMOURA, MD [email protected]

Groupe Hospitalier de la Région de Mulhouse Sud Alsace Not yet recruiting

Mulhouse, France, 68100

Contact: Guylaine LABRO, MD [email protected]

Hôpital Pitié Salpêtrière - Service de Médecine Interne Recruiting

Paris, France, 75013

Contact: Zahir AMOURA, MD [email protected]

Hôpital Sainte-Anne Not yet recruiting

Paris, France, 75014

Contact: Raphael GAILLARD, MD [email protected]

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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Principal Investigator: Zahir AMOURA, MD Assistance Publique - Hôpitaux de Paris

More Information Go to

Responsible Party: Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier: NCT04583410 History of Changes
Other Study ID Numbers: APHP200538
2020-003722-23 ( EudraCT Number )
First Posted: October 12, 2020 Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Covid19
SARS-COV2
Preventing infection

Additional relevant MeSH terms:

Infections Respiratory Tract Diseases
COVID-19 Nicotine
Severe Acute Respiratory Syndrome Ganglionic Stimulants
Respiratory Tract Infections Autonomic Agents
Pneumonia, Viral Peripheral Nervous System Agents
Pneumonia Physiological Effects of Drugs
Virus Diseases Nicotinic Agonists
Coronavirus Infections Cholinergic Agonists
Coronaviridae Infections Cholinergic Agents
Nidovirales Infections Neurotransmitter Agents
RNA Virus Infections Molecular Mechanisms of Pharmacological Action
Lung Diseases

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