Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients

NCT ID: NCT04608201

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2021-11-05

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. To current knowledge, there is no treatment yet that that can prevent infection from SARS-COV-2 virus, nor the disease progression to a severe form.

Daily active smokers are rare among outpatients or hospitalized COVID-19 patients.

Several arguments suggest that nicotine could be responsible for this protective effect thank to the nicotinic acetylcholine receptor (nAChR).

Based on epidemiological data and experimental data from scientific literature, we hypothesize that nicotine could inhibit the penetration and spread of the virus and improve the management of COVID19 , particularly in hospitalized patients to prevent adverse outcomes (death, transfer to intensive care unit, care limitation, mechanical ventilation an high flow oxygen).

Conditions

SARS-COV2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NICOTINE transdermal patch

NICOTINE 7 mg / 24h, transdermal patch

Group Type: EXPERIMENTAL

Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour

Intervention Type: DRUG

Treatment involves escalating doses to the target dose of 14 mg / day

1. / Dose escalation:

• Level 1: 3.5 mg/day (1/2 patch) for 2 days (D1 and D2)
• Level 2: 7 mg/day (1 patch) for 2 days (D3 and D4)
• Level 3: 10.5 mg/day (1.5 patch) for 2 days (D5 and D6)
• Level 4: target dose = 14 mg/day (from D7 to discharge from hospital + 1 week or maximum 5 weeks after the start of treatment)

2. / Decrease in dose (1 week after exit from hospital or maximum 5 weeks after the start of treatment): Decrease of 3.5 mg (1/2 patch) per week (over 3 weeks maximum)

Placebo of NICOTINE transdermal patch

Placebo of nicotine patch

Group Type: PLACEBO_COMPARATOR

Placebo of NICOTINE Transdermal patch

Intervention Type: DRUG

Placebo of nicotine patch administered to the same administration schedule as in the experimental arm

Interventions

Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour

Treatment involves escalating doses to the target dose of 14 mg / day

1. / Dose escalation:

• Level 1: 3.5 mg/day (1/2 patch) for 2 days (D1 and D2)
• Level 2: 7 mg/day (1 patch) for 2 days (D3 and D4)
• Level 3: 10.5 mg/day (1.5 patch) for 2 days (D5 and D6)
• Level 4: target dose = 14 mg/day (from D7 to discharge from hospital + 1 week or maximum 5 weeks after the start of treatment)

2. / Decrease in dose (1 week after exit from hospital or maximum 5 weeks after the start of treatment): Decrease of 3.5 mg (1/2 patch) per week (over 3 weeks maximum)

Intervention Type: DRUG

Placebo of NICOTINE Transdermal patch

Placebo of nicotine patch administered to the same administration schedule as in the experimental arm

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Patients hospitalized for less than 72 hours
• Non-smoking and non-vaping patients (for former smokers or former vapers: abstinent for at least 12 months)
• Documented diagnosis of COVID19
• Lung disease suggestive of COVID-19 on chest scanner or need for oxygen therapy
• Obtaining, informed and signed consent
• Affiliated to a social security scheme or beneficiary of such a scheme (except AME)

Exclusion Criteria

• WHO 10-point Clinical Progression Scale score > 5 (patient on non-invasive or mechanical ventilation, patient in need of high-flow oxygen therapy)
• Indication of transfer to intensive care unit (oxygen therapy> 8 L / min ; out or not carried out due to LATA)
• Current treatment with nicotine replacement therapy, bupropion or varenicline in the last 30 days
• Known addiction problem to alcohol or other substances
• Contraindication for nicotine patches:

• pregnant or breastfeeding woman
• lack of effective contraception for women of childbearing age
• Generalized skin pathologies that may 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 angina
• Severe cardiac arrhythmia (defined by wearing an automatic implantable defibrillator)
• Known obliterating peripheral arterial disease
• Known severe heart failure with an ejection fraction <30%)
• Known severe renal (ClCr <30 ml / min) or hepatic (Child C) impairment
• Known pheochromocytoma
• Known uncontrolled hyperthyroidism
• Esophagitis due to gastroesophageal reflux disease or an active peptic ulcer
• Patient included in another interventional trial evaluating a health product
• Patient under guardianship or curatorship
• Patient deprived of liberty by judicial or administrative decision

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valérie POURCHER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hospital Pitié-Salpêtrière - AP-HP

Paris, , France

Countries

France

Other Identifiers

2020-003743-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APHP200529

Identifier Type: -

Identifier Source: org_study_id