We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608201
Recruitment Status : Completed
First Posted : October 29, 2020
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).


Condition or disease Intervention/treatment Phase
SARS-COV2 Drug: Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour Drug: Placebo of NICOTINE Transdermal patch Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients
Actual Study Start Date : December 9, 2020
Actual Primary Completion Date : November 5, 2021
Actual Study Completion Date : November 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NICOTINE transdermal patch
NICOTINE 7 mg / 24h, transdermal patch
Drug: 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)

Placebo Comparator: Placebo of NICOTINE transdermal patch
Placebo of nicotine patch
Drug: Placebo of NICOTINE Transdermal patch
Placebo of nicotine patch administered to the same administration schedule as in the experimental arm




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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.


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

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): NCT04608201


Locations
Layout table for location information
France
Hospital Pitié-Salpêtrière - AP-HP
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Valérie POURCHER, MD, PhD Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04608201    
Other Study ID Numbers: APHP200529
2020-003743-28 ( EudraCT Number )
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

Layout table for additional information
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:
SARS-COV2
COVID19
NICOTINE
transdermal patch
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action