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Covid19Phase 3NICOVID-PREVNCT04583410

Efficacy of Nicotine in Preventing COVID-19 Infection

A Phase 3 study testing Nicotine patch in people with Covid19 and SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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
What is being tested?
Nicotine patch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,633 participants
Where
4 sitesFrance
Study dates
22 Oct 2020to Jun 2022
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

  • Aged 18 or over
  • May be followed for the duration of the study
  • Obtaining free, informed and signed consent
  • Affiliated to a social security scheme or beneficiary of such a scheme (except AME)
  • Non-smoker and non-vaping (for former smokers or vapers: abstinent for at least 12 months)

Who cannot join

  • Symptoms suggestive of COVID-19 on the day of inclusion or in the past 14 days
  • Documented history of COVID-19 and / or positive SARS-COV2 serology before the day of inclusion
  • Treatment ongoing with nicotine replacement therapy, varenicline or bupropion within 30 days before inclusion
  • Known addiction problem to alcohol (defined by AUDIT-C > or = 10) or other substances.
  • Vaccinated against COVID19 infection.
  • Contraindications for nicotine patches:
Show all 21Show fewer
  • pregnant woman (negative pregnancy test on inclusion) or breastfeeding woman
  • lack of effective contraception for women of childbearing potential
  • Generalized skin conditions that can 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 angor
  • Severe cardiac arrhythmia (defined by wearing an automatic implantable defibrillator)
  • Obliterating peripheral arterial disease
  • Known severe heart failure
  • Known severe renal or hepatic impairment,
  • Pheochromocytoma
  • Uncontrolled hyperthyroidism
  • Esophagitis due to gastroesophageal reflux disease or active peptic ulcer
  • 7 Already included in an interventional trial evaluating a health product 8 Staff under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision 9 Do not have a smartphone

Trial locations and contacts

4 sites in 1 country.

Zahir AMOURA, MD contact

+33142178244

zahir.amoura@aphp.fr

Florence TUBACH, MD contact

florence.tubach@aphp.fr

France4 sites, 4 recruiting

  • Centre Hospitalier Gonesse

    Gonesse, 95500

    Isabelle AMOURA, MD, isabelle.amoura@ch-gonesse.fr

    Recruiting

  • Groupe Hospitalier de la Région de Mulhouse Sud Alsace

    Mulhouse, 68100

    Guylaine LABRO, MD, guylaine.labro@ghrmsa.fr

    Not yet recruiting

  • Hôpital Pitié Salpêtrière - Service de Médecine Interne

    Paris, 75013

    Zahir AMOURA, MD, zahir.amoura@aphp.fr

    Recruiting

  • Hôpital Sainte-Anne

    Paris, 75014

    Raphael GAILLARD, MD, r.gaillard@ghu-paris.fr

    Not yet recruiting

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.

According to current knowledge, there are no treatments that prevent the spread of the infection, especially in exposed populations, or the disease progression to a severe form.

Read more

Daily active smokers are infrequent among outpatients or hospitalized patients with COVID-19. Several arguments suggest that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR).

Nicotine may inhibit the penetration and spread of the virus and have a prophylactic effect in COVID-19 infection.

However, the epidemic is progressing throughout French territory and new variants (in particular the "English B1. 1.7 variant of SARS-COV-2") much more contagious run a risk of accelerating the epidemic in the population. The anti-SARS-COV-2 vaccines recently launched (or being evaluated) represent great hope in this health crisis, but trials were only able to show their effectiveness on symptomatic forms of SARS-COV-2 infection. On the one hand, the vaccination compaign for the entire population requires many months,which leaves many unprotected subjects waiting. In addition, there is currently no evidence of a protective role of vaccines against asymptomatic forms of COVID-19 and therefore on SARS-COV-2 transmission. Finally, the nicotine patches may protect people in hight-risk areas/periods until they are vaccinated (if they accept it and are eligible for it) and in the post-vaccination weeks necessary for the effectiveness of the vaccine,which reinforces the importance of evaluating this alternative prevention strategy, in the context of the arrival of vaccines

Being tested
Nicotine patch, Placebo patch
Keywords
Covid19, SARS-COV2, Preventing infection
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 patchDrug

    NICOPATCHLIB, 7mg/24h Day 1 to day 3 : 3,5 mg/day Day 4 to day 9 : 7 mg/day Day 10 to Day 15 : 10,5 mg/day Day 16 to day 98 : 14 mg/day

    Decrease treatment Day 99 to day 105 : 10,5 mg/day Day 106 to day 112 : 7 mg/day Day 113 to Day 119 : 3,5 mg/day

  • Placebo patchDrug

    PLACEBO OF NICOPATCHLIB, 7mg/24h Day 1 to day 3 : 3,5 mg/day Day 4 to day 9 : 7 mg/day Day 10 to Day 15 : 10,5 mg/day Day 16 to day 98 : 14 mg/day

    Decrease treatment Day 99 to day 105 : 10,5 mg/day Day 106 to day 112 : 7 mg/day Day 113 to Day 119 : 3,5 mg/day

Study groups in NCT04583410
Study groupRoleWhat they receive
Nicotine patchExperimentalNot described
Receives: Drug: Nicotine patch
Placebo patchPlacebo comparatorNot described
Receives: Drug: Placebo patch

What is being measured

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

  1. SARS-COV2 seroconversion between W0 and W19 after randomization

    This is the proportion of subjects with at least one positive serology between W2 and W19. The time of S19 takes into account a seroconversion delay of 5 weeks in relation to the SARS-CoV2 contamination.

    Measured: Between week 0 and week 19

Secondary outcomes (18)

  1. Proportion of documented symptomatic COVID-19 infection

    Measured: Week 8, Week16

  2. SARS-COV2 seroconversion

    This is the proportion of patients with at least one positive serology between W2 and W16.

    Measured: Week 16

  3. Asymptomatic COVID-19 infection proportion at week 14

    Asymptomatic COVID-19 infection is defined as SARS-CoV2 seroconversion at Week 19 without symptoms suggestive of COVID until the end of Week 16 to take in account of the two weeks of incubation period

    Measured: Week 14

  4. Proportion of severe COVID-19 infection

    documented infection (positive SARS-CoV2 PCR test and / or suggestive chest CT scan and / or seroconversion) whose first symptoms appeared before W8 and W16 respectively, and requiring hospitalization or home oxygen therapy, or having resulted in death

    Measured: Week 8, Week16

  5. Number of sick leaves for a COVID-19 infection

    Measured: Week 16

  6. Number of days off during sick leaves for a COVID-19 infection

    Measured: Week 16

  7. Proportion of AE, SAE

    Measured: From inclusion and week 25

  8. Intensity and frequency of nausea, dizziness, feeling of empty head, headache, vomiting

    Measured: Week 25

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

    Measured: Week 25

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

    Measured: Week 25

  11. Mean score of Desire to smoke defined by French Tobacco Craving scale

    Measured: Week 25

  12. Mean score of Withdrawal symptoms scale

    Measured: Week 25

  13. Dosage of cotinine in the urine

    Measured: Week 8 and 25

  14. Mean score of Fatigue Numeric rating scale

    Measured: Week 2, week 8, week 16

  15. Weight

    Measured: Week 8, week 16, week 25

  16. Mean score of Hospital anxiety and depression scale

    Measured: Week 2, week 8, week 16

  17. Mean score of Insomnia severity scale

    Measured: Week 2, week 8, week 16

  18. Positive and negative syndrome scale

    Measured: Week 2, week 8, week 16

Timeline

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

  1. First posted12 Oct 2020
  2. Study start22 Oct 2020
  3. Primary completionDec 2021 (estimated)
  4. Study completionJun 2022 (estimated)

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
1,633 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04583410
Sponsor's protocol ID
APHP200538
Other IDs
2020-003722-23
Acronym
NICOVID-PREV
Status last verified
Feb 2021
First submitted
28 Sep 2020
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicotine patch in people with Covid19 and SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 5 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Results are not available in the source record.

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

Contact Zahir AMOURA, MD (+33142178244, zahir.amoura@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-COV2 seroconversion between W0 and W19 after randomization (time frame: Between week 0 and week 19). 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 NCT04583410.

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 17 Feb 2021.

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