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Repurposing of Chlorpromazine in Covid-19 Treatment

NCT04366739 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-07-10

No results posted yet for this study

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).

Conditions

Interventions

DRUG

CHLORPROMAZINE (CPZ)

Drug List 1, AMM obtained in 1952, AMM 3400930571187 1952/90, RCP revised 22/08/2019 Administration: oral route, if the clinical condition requires it, intravenous administration. Initial dosage: 75 mg per day orally (or 37.5 mg per day orally in subjects 75 years of age or older). Then: titration up to the maximum tolerated dose, with a minimum of 12.5 mg and a maximum of 300 mg per day by the oral administration (or 600 mg per day by the oral in certain exceptional cases which also correspond to the CPM CPM marketing authorization indications); or from 6.25 to 150 mg per day intravenously. Duration of treatment: until healing criteria are obtained (≥ 8 days from the onset of COVID-19 symptoms AND ≥ 48 hours of apyrexia and absence of dyspnea) or 21 days maximum

COMBINATION_PRODUCT

Standard of Care (SOC)

In the absence of a reference treatment in COVID-19, the "standard of care" (SOC) is the comparison arm

Sponsors & Collaborators

  • Hôpital Cochin

    collaborator OTHER

  • Centre Hospitalier St Anne

    lead OTHER

Principal Investigators

  • Marion Plaze, MD, PHD · Service Hospitalo-Universitaire - GHU PARIS Psychiatrie & Neurosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-29
Primary Completion
2020-08-30
Completion
2020-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04366739 on ClinicalTrials.gov