Repurposing of Chlorpromazine in Covid-19 Treatment

• Status: Not yet recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effects of the addition of chlorpromazine to the standard therapeutic protocol in COVID-19 patients hospitalized for respiratory symptom management (score 3-5 WHO Ordinal Scale for Clinical Improvement).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier St Anne
• Collaborator: Hôpital Cochin
• Treatments: Chlorpromazine

Criteria

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

Exclusion Criteria:

• 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