Status:
WITHDRAWN
Repurposing of Chlorpromazine in Covid-19 Treatment
Lead Sponsor:
Centre Hospitalier St Anne
Collaborating Sponsors:
Hôpital Cochin
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Scal...
Detailed Description
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 Scal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04366739
Start Date
April 29 2020
End Date
September 30 2020
Last Update
July 10 2024
Active Locations (1)
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1
Centre Hospitalier Sainte-Anne
Paris, France, 75014