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Trial - NCT04609865


Column Value
Trial registration number NCT04609865
Full text link
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04609865

First author
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Thiên-Nga CHAMARAUX-TRAN, MD

Contact
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

thiennga.chamaraux-tran@chru-strasbourg.fr

Registration date
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-10-30

Recruitment status
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - age ≥18 years - hospitalized in icu - presence of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms: - pao2/fio2 <300 mmhg with positive end-expiratory pressure (peep) ≥5 cmh2o - bilateral opacities not fully explained by cardiac failure or fluid overload - intubated and sedated for mechanical protective ventilation - affiliation to the french sociale security - beta hcg negative for women for covid-19 subgroup: - covid-19 infection (rt-pcr < 7 days and/or another approved diagnostic technique and/or typical ct appearance of covid-19 pneumonia

Exclusion criteria
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- allergy to amide local anesthetics - acute porphyria - disorders of atrioventricular conduction requiring a non-done permanent electrosystolic pacing - uncontrolled epilepsy - fluvoxamine treatment - class iii antiarrythmic agent treatments (amiodarone, dronedarone) - class i antiarythmic agent (quinidine, disopyramide, hydroquinidine, flecainid, propafenone) - hepatocellular insufficiency defined by pt<15% in the absence of anti-vitamin k - patient under a tutelage measure or placed under judicial protection - known pregnancy - breastfeeding

Number of arms
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University Hospital, Strasbourg, France

Inclusion age min
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

primary outcome
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

alveolar-capillary gas exchange after two days of treatment

Notes
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 733, "treatment_name": "Lidocaine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]