v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04608201 |
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Full text link
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Feb. 12, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Feb. 12, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
valerie.martinez@aphp.fr |
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Registration date
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-10-29 |
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Recruitment status
Last imported at : Feb. 12, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Dec. 16, 2020, 10:02 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - age ≥ 18 years - patients hospitalized for less than 72 hours - non-smoking and non-vaping patients (for former smokers or former vapers: abstinent for at least 12 months) - documented diagnosis of covid19 - lung disease suggestive of covid-19 on chest scanner or need for oxygen therapy - obtaining, informed and signed consent - affiliated to a social security scheme or beneficiary of such a scheme (except ame) |
|
Exclusion criteria
Last imported at : Dec. 16, 2020, 10:02 a.m. Source : ClinicalTrials.gov |
- 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: - pregnant or breastfeeding woman - lack of effective contraception for women of childbearing age - generalized skin pathologies that may interfere with the use of a transdermal patch - stroke or myocardial infarction or acute coronary syndrome for less than 3 months - allergy to nicotine or to one of the excipients of the transdermal patch - uncontrolled high blood pressure - unstable or worsening angina - severe cardiac arrhythmia (defined by wearing an automatic implantable defibrillator) - known obliterating peripheral arterial disease - known severe heart failure with an ejection fraction <30%) - known severe renal (clcr <30 ml / min) or hepatic (child c) impairment - known pheochromocytoma - known uncontrolled hyperthyroidism - esophagitis due to gastroesophageal reflux disease or an active peptic ulcer - 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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Number of arms
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Assistance Publique - Hôpitaux de Paris |
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Inclusion age min
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate disease at enrollment |
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Severity scale
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3: Moderate disease at enrollment |
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Total sample size
Last imported at : Feb. 12, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
32 |
|
primary outcome
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
The unfavorable outcome on Day 14 |
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Notes
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 886, "treatment_name": "Nicotine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}] |