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

NCT04608201 | Completed Phase 3

• 2 other identifiers: APHP2005292020-003743-28
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

SARS-COV2; COVID19; NICOTINE; transdermal patch

Outcome Measures

Primary Outcomes (1)

• The unfavorable outcome on Day 14

  Defined by scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 14

  Day 14

Secondary Outcomes (27)

• Survival rate

  Day 14, Day 28

• Proportion of transfer to intensive care unit (ICU)

  Day 14, Day 28

• Proportion of indication of transfer to intensive care unit (carried out or not in case of LATA)

  Day 14, Day 28

• Number of days living without mechanical ventilation

  Day 14, Day 28

• Number of days living without non-invasive ventilation and mechanical ventilation

  Day 4, Day 14, Day 28

Study Arms (2)

NICOTINE transdermal patch

EXPERIMENTAL

NICOTINE 7 mg / 24h, transdermal patch

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

Placebo of NICOTINE transdermal patch

PLACEBO COMPARATOR

Placebo of nicotine patch

Drug: Placebo of NICOTINE Transdermal patch

Interventions

Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour 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)

NICOTINE transdermal patch

Placebo of NICOTINE Transdermal patch DRUG

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

Placebo of NICOTINE transdermal patch

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Pitié-Salpêtrière - AP-HP

Paris, 75013, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nicotine; Transdermal Patch

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)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Equipment and Supplies

Study Officials

• Valérie POURCHER, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

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: October 23, 2020
• First Posted: October 29, 2020
• Study Start: December 9, 2020
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

FR (1)