Skip to main content
OpenTrials
Completed

NCT Number: NCT04608201

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sars-CoV2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Pitié-Salpêtrière - AP-HP

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour

Drug

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

  • / 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)
  • / 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

Drug

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

Primary outcomes

  1. The unfavorable outcome on Day 14

    Time frame: Day 14

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

Secondary outcomes

  1. Survival rate

    Time frame: Day 14, Day 28

  2. Proportion of transfer to intensive care unit (ICU)

    Time frame: Day 14, Day 28

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

    Time frame: Day 14, Day 28

  4. Number of days living without mechanical ventilation

    Time frame: Day 14, Day 28

  5. Number of days living without non-invasive ventilation and mechanical ventilation

    Time frame: Day 4, Day 14, Day 28

  6. Proportion of patient with a score higher than 6 on the World Health Organization 10-point Clinical Progression Scale

    Time frame: Day 14

  7. Duration of hospitalization

    Time frame: Fom day 1 up to 3 month

  8. Proportion of patient in each category of the World Health Organization 10-point Clinical Progression Scale

    Time frame: Day 7, Day 14 and Day 28

  9. Proportion of patient in each category of the National Early Warning Scale (NEWS) 2

    Time frame: Day 7, Day14 and Day28 (or the day of discharge from hospital)

  10. Proportion of patient with a SARS-CoV-2 viral load detection

    Time frame: Day 7 or the day of discharge from hospital if before day 7

  11. Mean evolution of blood count

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  12. Mean evolution of platelets

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  13. Mean evolution of blood ionogram

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  14. Mean evolution of glycemia

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  15. Mean evolution of serum creatinine

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  16. Mean evolution of C reactive protein

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  17. Mean evolution of Interleukin 6 (IL-6)

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  18. Mean evolution of oxygen requirements (number of liters / min)

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  19. Mean evolution of SaO2

    Time frame: At randomization then every 3 days until discharge, or up to 5 weeks

  20. Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination

    Time frame: Week 2 after treatment decrease, Week 8 after treatment decrease

  21. Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine

    Time frame: Week 8 after treatment decrease

  22. Mean score of Desire to smoke defined by French Tobacco Craving questionnaire (FTCQ12 )

    Time frame: Week 2 after treatment decrease, Week 8 after treatment decrease

  23. Mean score of Cigarette Withdrawal Scale (CWS)

    Time frame: Week 2 after treatment decrease, Week 8 after treatment decrease

  24. Mean score of Hospital anxiety and depression scale (HAD)

    Time frame: Week 2 after treatment decrease, Week 8 after treatment decrease

  25. Mean score of Positive and Negative Affect Schedule (PANAS)

    Time frame: Week 2 after treatment decrease, Week 8 after treatment decrease

  26. Mean score of Insomnia severity scale (ISI)

    Time frame: Week 2 after treatment decrease, Week 8 after treatment decrease

  27. weight evolution

    Time frame: Day 1, Week 2 after treatment decrease, Week 8 after treatment decrease

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: NICOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.