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SARS-COV2Phase 3NICOVIDNCT04608201

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

A Phase 3 study testing Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour in people with SARS-COV2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-COV2
What is being tested?
Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteFrance
Study dates
9 Dec 2020to 5 Nov 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hospital Pitié-Salpêtrière - AP-HP

    Paris, 75013

Other trials in France

About this study

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.

Read more

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
Being tested
Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour, Placebo of NICOTINE Transdermal patch
Keywords
SARS-COV2, COVID19, NICOTINE, transdermal patch
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine 7 mg/ 24h Transdermal Patch - 24 HourDrug

    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)
    1. / 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 patchDrug

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

Study groups in NCT04608201
Study groupRoleWhat they receive
NICOTINE transdermal patchExperimentalNICOTINE 7 mg / 24h, transdermal patch
Receives: Drug: Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour
Placebo of NICOTINE transdermal patchPlacebo comparatorPlacebo of nicotine patch
Receives: Drug: Placebo of NICOTINE Transdermal patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 14

Secondary outcomes (27)

  1. Survival rate

    Measured: Day 14, Day 28

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

    Measured: Day 14, Day 28

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

    Measured: Day 14, Day 28

  4. Number of days living without mechanical ventilation

    Measured: Day 14, Day 28

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

    Measured: 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

    Measured: Day 14

  7. Duration of hospitalization

    Measured: Fom day 1 up to 3 month

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

    Measured: Day 7, Day 14 and Day 28

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

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

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

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

  11. Mean evolution of blood count

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

  12. Mean evolution of platelets

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

  13. Mean evolution of blood ionogram

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

  14. Mean evolution of glycemia

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

  15. Mean evolution of serum creatinine

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

  16. Mean evolution of C reactive protein

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

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

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

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

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

  19. Mean evolution of SaO2

    Measured: 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

    Measured: 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

    Measured: Week 8 after treatment decrease

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

    Measured: Week 2 after treatment decrease, Week 8 after treatment decrease

  23. Mean score of Cigarette Withdrawal Scale (CWS)

    Measured: Week 2 after treatment decrease, Week 8 after treatment decrease

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

    Measured: Week 2 after treatment decrease, Week 8 after treatment decrease

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

    Measured: Week 2 after treatment decrease, Week 8 after treatment decrease

  26. Mean score of Insomnia severity scale (ISI)

    Measured: Week 2 after treatment decrease, Week 8 after treatment decrease

  27. weight evolution

    Measured: Day 1, Week 2 after treatment decrease, Week 8 after treatment decrease

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start9 Dec 2020
  3. Primary completion5 Nov 2021
  4. Study completion5 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04608201
Sponsor's protocol ID
APHP200529
Other IDs
2020-003743-28
Acronym
NICOVID
Status last verified
Feb 2022
First submitted
23 Oct 2020
Last updated
11 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour in people with SARS-COV2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The unfavorable outcome on Day 14 (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04608201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.

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