• Guylaine Labro, Florence Tubach, Lisa Belin, Jean-Louis Dubost, David Osman, Grégoire Muller, QuenotJean-PierreJPDepartment of Intensive Care, Burgundy University Hospital, Dijon, France.Lipness Team, INSERM Research Center LNC-UMR1231 and LabEx LipSTIC, University of Burgundy, Dijon, France.INSERM CIC 1432, Clinical Epidemiology, University of Bu, Daniel Da Silva, Jonathan Zarka, Matthieu Turpin, Julien Mayaux, Christian Lamer, Denis Doyen, Guillaume Chevrel, Gaétan Plantefeve, Sophie Demeret, Gaël Piton, Cyril Manzon, Evelina Ochin, Raphael Gaillard, Bertrand Dautzenberg, Mathieu Baldacini, Said Lebbah, Makoto Miyara, Pineton de ChambrunMarcMService de Médecine Intensive-Réanimation, Institut de Cardiologie, APHP Hôpital Pitié-Salpêtrière, 75013, Paris, France.INSERM, UMRS_1166-ICAN, Institute of Cardiometabolism and Nutrition, Sorbonne Université, 47, Boulevard de l'H, Zahir Amoura, Alain Combes, and NICOVID-REA Trial Group.
• Service de Médecine Intensive-Réanimation Groupement Hospitalier Régional Mulhouse Et Sud Alsace, Hôpital Emile Muller, 68100, Mulhouse, France.
• Intensive Care Med. 2022 Jul 1; 48 (7): 876887876-887.

PurposeEpidemiologic studies have documented lower rates of active smokers compared to former or non-smokers in symptomatic patients affected by coronavirus disease 2019 (COVID-19). We assessed the efficacy and safety of nicotine administered by a transdermal patch in critically ill patients with COVID-19 pneumonia.MethodsIn this multicentre, double-blind, placebo-controlled trial conducted in 18 intensive care units in France, we randomly assigned adult patients (non-smokers, non-vapers or who had quit smoking/vaping for at least 12 months) with proven COVID-19 pneumonia receiving invasive mechanical ventilation for up to 72 h to receive transdermal patches containing either nicotine at a daily dose of 14 mg or placebo until 48 h following successful weaning from mechanical ventilation or for a maximum of 30 days, followed by 3-week dose tapering by 3.5 mg per week. Randomization was stratified by centre, non- or former smoker status and Sequential Organ Function Assessment score (< or ≥ 7). The primary outcome was day-28 mortality. Main prespecified secondary outcomes included 60-day mortality, time to successful extubation, days alive and free from mechanical ventilation, renal replacement therapy, vasopressor support or organ failure at day 28.ResultsBetween November 6th 2020, and April 2nd 2021, 220 patients were randomized from 18 active recruiting centers. After excluding 2 patients who withdrew consent, 218 patients (152 [70%] men) were included in the analysis: 106 patients to the nicotine group and 112 to the placebo group. Day-28 mortality did not differ between the two groups (30 [28%] of 106 patients in the nicotine group vs 31 [28%] of 112 patients in the placebo group; odds ratio 1.03 [95% confidence interval, CI 0.57-1.87]; p = 0.46). The median number of day-28 ventilator-free days was 0 (IQR 0-14) in the nicotine group and 0 (0-13) in the placebo group (with a difference estimate between the medians of 0 [95% CI -3-7]). Adverse events likely related to nicotine were rare (3%) and similar between the two groups.ConclusionIn patients having developed severe COVID-19 pneumonia requiring invasive mechanical ventilation, transdermal nicotine did not significantly reduce day-28 mortality. There is no indication to use nicotine in this situation.© 2022. Springer-Verlag GmbH Germany, part of Springer Nature.

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