Patch, Nicotine
DrugTwo patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day
NCT Number: NCT04598594
There is currently no known treatment for COVID19. Active smokers are infrequent among patients with COVID-19 which has led our team to hypothesize that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). In fact, nAChR possess the ability to modulate ACE2 expression, the cellular doorway for SARS-CoV2. nAChR modulation by the virus would be responsible for the numerous clinical signs observed in COVID-19, including the cytokine storm manifested in intensive care hyperinflammatory patients.
Based on epidemiological data and experimental data from scientific literature, our team hypothesize that nicotine could inhibit the penetration and propagation of SARS-CoV2. Our team also claim that nicotine could attenuate the hyperinflammatory response and cytokine storm leading to acute respiratory failure and a probable multi-organ failure associated with COVID19.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Centre Hospitalier Victor Dupouy - Service de Réanimation polyvalente et USC, Argenteuil, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day
Two patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day
Time frame: Day 28
Time frame: Day 60
Time frame: Day 60
Without reintubation or death in the following 48 hours for tracheotomized patients: alive and not ventilated for 48 hours (with death and LATA in competitive risks).
Time frame: Day 28
Time frame: Day 60
This is a ranked composite score that incorporates death and days free from mechanical ventilation through day 28, calculated in such a manner that death constitutes a worse outcome than fewer days off the ventilator.16 Time free from mechanical ventilation was calculated as the number of days between successful liberation from the ventilator and study day 60. Each patient was compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better
Time frame: Day 1 to Day 14
measured each day from day 1 to day 14
Time frame: Day 1 to Day 14
measured each day from day 1 to day 14
Time frame: Day 1 to Day 14
measured each day from day 1 to day 14
Time frame: Day 1 to Day 14
measured each day from day 1 to day 14
Time frame: Day 1 to Day 14
measured each day from day 1 to day 14
Time frame: Day 1 to Day 14
measured each day from day 1 to day 14
Time frame: Day 1 to Day 28
A higher score indicate a worse outcome
Time frame: Day 28, day 60
Time frame: From day 1 up to 3 months
Time frame: From day 1 up to 3 months
Time frame: Day 28, day 60
Time frame: Day 7, Day 14 or day of ICU discharge if before day 14
samples taken on D7 and D14 or the day of discharge from intensive care unit if before D14
Time frame: 2 weeks after treatment decrease, 8 weeks after treatment decrease
Time frame: 2 weeks after treatment decrease, 8 weeks after treatment decrease
Time frame: 2 weeks after treatment decrease, 8 weeks after treatment decrease
Time frame: 2 weeks after treatment decrease, 8 weeks after treatment decrease
Time frame: 2 weeks after treatment decrease, 8 weeks after treatment decrease
Time frame: 2 weeks after treatment decrease, 8 weeks after treatment decrease
Time frame: 2 weeks after treatment decrease
Time frame: 8 weeks after treatment decrease
Assistance Publique - Hôpitaux de Paris
Other
Acronym: NICOVID-REA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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