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NCT04598594
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Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Intensive Care Unit Patients |
Completed |
Phase 3 |
Nov/06/2020 |
Jun/20/2021 |
- Alternative id - APHP200537|2020-003723-42
- Interventions - Drug: Patch, Nicotine|Drug: Patch, Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Centre Hospitalier Victor Dupouy - Service de Réanimation polyvalente et USC, Argenteuil, France|CHRU de Besançon - Service de Médecine Intensive Réanimation, Besançon, France|Centre Hospitalier Sud Francilien - Service de réanimation, Corbeil-Essonnes, France|CHU Dijon - Hôpital François Miterrand Service de Médecine Intensive Réanimation, Dijon, France|Hôpital Simone VEIL - Service d'Anesthésie-Réanimation, Eaubonne, France|Grand Hôpital de l'Est Francilien - Site Jossigny - Réanimation, Jossigny, France|Hôpital Bicêtre - Service de Médecine Intensive Réanimation, Le Kremlin-Bicêtre, France|Grand Hôpital de l'Est Francilien Site Meaux - Service de Réanimation Médico-Chirurgicale, Meaux, France|Groupement Hospitalier de la Région de Mulhouse Sud Alsace - Hop Emile MULLER, Mulhouse, France|CHU Nice - Hôpital L'Archet 1 - Service de Médecine Intensive Réanimation, Nice, France|CHR Orléans Service de Médecine Intensive Réanimation, Orléans, France|Hôpital Pitié Salpêtrière - ICU, Paris, France|Hôpital Pitié Salpêtrière - Intensive care unit, Paris, France|Institut Mutualiste Montsouris Service de Réanimation Polyvalente, Paris, France|Hôpital Tenon - Service de Médecine Intensive Réanimation, Paris, France|Centre Hospitalier René Dubos - Service de Réanimation Médico-Chirurgicale, Pontoise, France|Hôpital DELAFONTAINE Service de Médecine Intensive Réanimation, Saint-Denis, France|Médipôle Hôpital Privé - MHP Service de Médecine Intensive Réanimation, Villeurbanne, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 220
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mortality|Time before successful extubation|Number of days living without invasive mechanical ventilation|Composite score incorporating death and the number of days living without mechanical ventilation|Mean evolution of blood gases|Mean evolution of Tidal Volume (ventilator parameters)|Mean evolution of respiratory rate (ventilator parameters)|Mean evolution of Positive Expiratory Pressure (ventilator parameters)|Mean evolution of plateau pressure (ventilator parameters)|Mean evolution of fraction of inspired oxygen (ventilator parameters)|Evolution of the Sequential Organ Failure Assessment (SOFA) score and its components by organ|Number of days alive without organ failure|Duration of hospitalization in intensive care unit|Duration of hospitalization in hospital|Number of days alive and out of the ICU and hospital|Evolution of viral load|Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination|Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine|Mean score of Desire to smoke defined by French Tobacco Craving scale|Mean score of Withdrawal symptoms scale|Mean score of Hospital anxiety and depression scale|Post traumatic stress disorder scale|Mean score of Insomnia severity scale|Cotinin rate in blood
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NCT04429815
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Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19 |
Completed |
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Aug/25/2020 |
May/26/2021 |
- Alternative id - 2020-A01681-38
- Interventions - Diagnostic Test: Serological test for COVID-19.
- Study type - Observational
- Study results - No Results Available
- Locations - CHRU Nancy, Vandoeuvre-les-Nancy, France
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 195
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Percentage of patients with a positive serological test for COVID-19.
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NCT04583761
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Tobacco and Nicotine Consumption and the Risk of Acquisition of Coronavirus Disease 2019 (COVID-19) |
Completed |
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Oct/14/2020 |
Feb/06/2021 |
- Alternative id - APHP200663
- Interventions - Behavioral: questionnaire
- Study type - Observational
- Study results - No Results Available
- Locations - Hotel-Dieu Hospital, Paris, France
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 622
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - questionnaire to assess strength of correlation between current smoking and SARS-CoV-2 RT-PCR positivity|questionnaire to assess strength of correlation between current alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity|questionnaire to assess strength of correlation between former smokers and SARS-CoV-2 RT-PCR positivity|questionnaire to assess strength of correlation between former alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity
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NCT04583410
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Efficacy of Nicotine in Preventing COVID-19 Infection |
Recruiting |
Phase 3 |
Oct/22/2020 |
Jun/01/2022 |
- Alternative id - APHP200538|2020-003722-23
- Interventions - Drug: Nicotine patch|Drug: Placebo patch
- Study type - Interventional
- Study results - No Results Available
- Locations - Centre Hospitalier Gonesse, Gonesse, France|Groupe Hospitalier de la Région de Mulhouse Sud Alsace, Mulhouse, France|Hôpital Pitié Salpêtrière - Service de Médecine Interne, Paris, France|Hôpital Sainte-Anne, Paris, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 1633
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - SARS-COV2 seroconversion between W0 and W19 after randomization|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|Number of days off during sick leaves for a COVID-19 infection|Proportion of AE, SAE|Intensity and frequency of nausea, dizziness, feeling of empty head, headache, vomiting|Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination|Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine|Mean score of Desire to smoke defined by French Tobacco Craving scale|Mean score of Withdrawal symptoms scale|Dosage of cotinine in the urine|Mean score of Fatigue Numeric rating scale|Weight|Mean score of Hospital anxiety and depression scale|Mean score of Insomnia severity scale|Positive and negative syndrome scale
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NCT04608201
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Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients |
Completed |
Phase 3 |
Dec/09/2020 |
Nov/05/2021 |
- Alternative id - APHP200529|2020-003743-28
- Interventions - Drug: Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour|Drug: Placebo of NICOTINE Transdermal patch
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Pitié-Salpêtrière - AP-HP, Paris, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 32
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - The unfavorable outcome on Day 14|Survival rate|Proportion of transfer to intensive care unit (ICU)|Proportion of indication of transfer to intensive care unit (carried out or not in case of LATA)|Number of days living without mechanical ventilation|Number of days living without non-invasive ventilation and mechanical ventilation|Proportion of patient with a score higher than 6 on the World Health Organization 10-point Clinical Progression Scale|Duration of hospitalization|Proportion of patient in each category of the World Health Organization 10-point Clinical Progression Scale|Proportion of patient in each category of the National Early Warning Scale (NEWS) 2|Proportion of patient with a SARS-CoV-2 viral load detection|Mean evolution of blood count|Mean evolution of platelets|Mean evolution of blood ionogram|Mean evolution of glycemia|Mean evolution of serum creatinine|Mean evolution of C reactive protein|Mean evolution of Interleukin 6 (IL-6)|Mean evolution of oxygen requirements (number of liters / min)|Mean evolution of SaO2|Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination|Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine|Mean score of Desire to smoke defined by French Tobacco Craving questionnaire (FTCQ12 )|Mean score of Cigarette Withdrawal Scale (CWS)|Mean score of Hospital anxiety and depression scale (HAD)|Mean score of Positive and Negative Affect Schedule (PANAS)|Mean score of Insomnia severity scale (ISI)|weight evolution
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