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Clinical Trial to assess benefit of adding Chlorpromazine to the current Standard of Care in treating patients who are moderately infected with COVID-19. Â

A Phase II B III, Multi Centre Open label Randomized Controlled trial to assess Clinical Benefits of Chlorpromazine and Standard of Care Versus Standard of Care alone in the management of moderate SARS COV 2 infection - Nil

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034064
Enrollment
176
Registered
2021-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Chlorpromazine tablet oral: Chlorpromazine 25mg BD Oral for 10 days,50mg BD Oral for 10 days,100mg BD Oral for 10 days Control Intervention1: Not applicable: Not Applicable

Sponsors

CSIRIICT
Lead Sponsor
Izatech Labs
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Documented COVID-19 infection as observed by positive RT-PCR for SARS-CoV-2 on the day of screening. Adult having moderate form of infection defined as presence of clinical features of dyspnea, and or hypoxia, fever, cough including spO2

Exclusion criteria

Exclusion criteria: Patients suffering from severe Covid-19 disease as per the physicianâ??s discretion. History of Chronic illness will be obtained and those with a history of active, ongoing disease will be excluded.

Design outcomes

Primary

MeasureTime frame
Time To Response TTR measured as the number of days since randomization in which there is reduction of at least one severity level of the disease measured using a World Health Organization 8 Point Ordinal Scale for Clinical Improvement WHO OSCI.Timepoint: Baseline and 3 weeks (21 days)

Secondary

MeasureTime frame
A decrease in the swab viral load of SARSCOV2 Reduction in the need for intensive care in the treatment arm versus SOC A decrease in inflammatory markers will be measured at screening and End of TreatmentTimepoint: Baseline and 3 weeks (21 days) 8.5 weeks (60 days) if SAE occurs

Countries

India

Contacts

Public ContactMr Shriram Vedapuri

ClinSync Clinical Research Pvt. Ltd.

attili@clinsynccro.com9246243034

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026