Efficacy of Nicotine in Preventing COVID-19 Infection

What Was Tested

The trial (phase 3) is built around Therapeutic nicotine (patch, non-peptide).

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.

It had two arms (groups): Nicotine patch (experimental) and Placebo patch (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1633 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged 18 or over. May be followed for the duration of the study. Obtaining free, informed and signed consent. Non-smoker and non-vaping (for former smokers or vapers: abstinent for at least 12 months).

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2020-10-22 with completion listed for 2021-12.

It ran at 4 sites in France (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): SARS-COV2 seroconversion between W0 and W19 after randomization (time frame: Between week 0 and week 19).

It also tracked 18 secondary outcomes, for example Proportion of documented symptomatic COVID-19 infection, SARS-COV2 seroconversion, Asymptomatic COVID-19 infection proportion at week 14, Proportion of severe COVID-19 infection, Number of sick leaves for a COVID-19 infection and Number of days off during sick leaves for a COVID-19 infection.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1633 people.

With 1633 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.