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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003743-28 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NICOTINE transdermal patch | Experimental | NICOTINE 7 mg / 24h, transdermal patch |
|
| Placebo of NICOTINE transdermal patch | Placebo Comparator | Placebo of nicotine patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour | Drug | Treatment involves escalating doses to the target dose of 14 mg / day
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Day 14, Day 28 | |
| Proportion of transfer to intensive care unit (ICU) | Day 14, Day 28 | |
| Proportion of indication of transfer to intensive care unit (carried out or not in case of LATA) |
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Inclusion Criteria:
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:
Patient included in another interventional trial evaluating a health product
Patient under guardianship or curatorship
Patient deprived of liberty by judicial or administrative decision
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| Name | Affiliation | Role |
|---|---|---|
| Valérie POURCHER, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pitié-Salpêtrière - AP-HP | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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|
| Placebo of NICOTINE Transdermal patch | Drug | Placebo of nicotine patch administered to the same administration schedule as in the experimental arm |
|
| Day 14, Day 28 |
| Number of days living without mechanical ventilation | Day 14, Day 28 |
| Number of days living without non-invasive ventilation and mechanical ventilation | Day 4, Day 14, Day 28 |
| Proportion of patient with a score higher than 6 on the World Health Organization 10-point Clinical Progression Scale | Day 14 |
| Duration of hospitalization | Fom day 1 up to 3 month |
| Proportion of patient in each category of the World Health Organization 10-point Clinical Progression Scale | Day 7, Day 14 and Day 28 |
| Proportion of patient in each category of the National Early Warning Scale (NEWS) 2 | Day 7, Day14 and Day28 (or the day of discharge from hospital) |
| Proportion of patient with a SARS-CoV-2 viral load detection | Day 7 or the day of discharge from hospital if before day 7 |
| Mean evolution of blood count | At randomization then every 3 days until discharge, or up to 5 weeks |
| Mean evolution of platelets | At randomization then every 3 days until discharge, or up to 5 weeks |
| Mean evolution of blood ionogram | At randomization then every 3 days until discharge, or up to 5 weeks |
| Mean evolution of glycemia | At randomization then every 3 days until discharge, or up to 5 weeks |
| Mean evolution of serum creatinine | At randomization then every 3 days until discharge, or up to 5 weeks |
| Mean evolution of C reactive protein | At randomization then every 3 days until discharge, or up to 5 weeks |
| Mean evolution of Interleukin 6 (IL-6) | At randomization then every 3 days until discharge, or up to 5 weeks |
| Mean evolution of oxygen requirements (number of liters / min) | At randomization then every 3 days until discharge, or up to 5 weeks |
| Mean evolution of SaO2 | At randomization then every 3 days until discharge, or up to 5 weeks |
| Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination | Week 2 after treatment decrease, Week 8 after treatment decrease |
| Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine | Week 8 after treatment decrease |
| Mean score of Desire to smoke defined by French Tobacco Craving questionnaire (FTCQ12 ) | Week 2 after treatment decrease, Week 8 after treatment decrease |
| Mean score of Cigarette Withdrawal Scale (CWS) | Week 2 after treatment decrease, Week 8 after treatment decrease |
| Mean score of Hospital anxiety and depression scale (HAD) | Week 2 after treatment decrease, Week 8 after treatment decrease |
| Mean score of Positive and Negative Affect Schedule (PANAS) | Week 2 after treatment decrease, Week 8 after treatment decrease |
| Mean score of Insomnia severity scale (ISI) | Week 2 after treatment decrease, Week 8 after treatment decrease |
| weight evolution | Day 1, Week 2 after treatment decrease, Week 8 after treatment decrease |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D004864 | Equipment and Supplies |