COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04366739

Marion Plaze, MD, PHD

m.plaze@ghu-paris.fr

2020-04-29

Not reported

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - biological and/or radiological diagnosis of covid-19 infection - who-osci at 3, 4 or 5 at the time of inclusion - benefiting from a social security scheme - voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the informed consent form (icf); willingness and capability to complete all the study procedures

- treatment with chlorpromazine (cpz) the month preceding the inclusion visit - contraindication to the cpz: - hypersensitivity to the active substance or any of the excipients - risk of glaucoma by closing the angle. - risk of urinary retention linked to urethroprostatic disorders. - history of agranulocytosis - association with dopaminergic outside parkinson's (cabergoline, quinagolide), citalopram, escitalopram, domperidone, hydroxyzine, and piperaquine - wheat allergy - risk of qt prolongation and occurrence of severe ventricular rhythm disorders: the existence of bradycardia, hypokalaemia, long congenital or acquired qt - history of ischemic stroke - treatment with chloroquine or hydroxychloroquine during the inclusion visit or the previous month - need for mechanical ventilation linked to covid-19, during the inclusion visit or the last month - in the opinion of the clinical team, imminent progression to death within the next 24 hours regardless of treatment - psychiatric care under duress - protected adults, persons under the protection of justice - pregnant or lactating woman

2

Centre Hospitalier St Anne

18

None

France

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

40

Time To Response (TTR)

None

Phase 3

[{"arm_notes": "", "treatment_id": 280, "treatment_name": "Chlorpromazine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]