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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

SARS-COV2

Treatments

Drug: Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour

Drug: Placebo of NICOTINE Transdermal patch

Study type

Interventional

Funder types

Other

Identifiers

NCT04608201

APHP200529

2020-003743-28 (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. 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).

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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