Administration of Chlorpromazine as a Treatment for COVID-19
1 other identifier
interventional
100
1 country
1
Brief Summary
In this study, defined cases of COVID-19 confirmed with PCR, with a mild, moderate or severe pneumonia will be treated with chlorpromazine. The improvement in clinical \& laboratory manifestations will be evaluated in treated patient compared to control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Aug 2020
Shorter than P25 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJuly 8, 2020
July 1, 2020
2 months
April 17, 2020
July 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical improvement
In the current study, the clinical improvement will be determined by: 1. Temperature 2. Heart rate (pulse) 3. Respiratory rate 4. Oxygen saturation 5. Need for oxygen 6. Hospital stay time. 7. CT lung involvement at day 0 and day 14.
2 weeks
Study Arms (2)
Group A
EXPERIMENTALThe group of 50 patients are going to receive Chlorpromazine (oral dose of 50 mg/ day for 3 days then doubled to 100mg/day for further 11 days) every 24 hours for 14 days in addition to the convential treatment of COVID-19 according to the Egyptian Ministry of Health protocol.
Group B
NO INTERVENTIONA group of 50 patients control group who will recieve only the convential treatment of COVID-19 according to the Egyptian Ministry of Health protocol.
Interventions
(Oral dose of 50 mg/ day for 3 days then doubled to 100mg/day for further 11 days)
Eligibility Criteria
You may qualify if:
- Adult conscious male and female (non-pregnant, non-breast feeder), level of consciousness is assessed by Glasgow Coma Scale ≥ 13.
- Diagnosed initially with COVID-19 confirmed with PCR prior to any interference.
- Follow the treatment regimen for COVID-19 according to The Ministry of Health in Egypt.
You may not qualify if:
- Patients having allergy to chlorpromazine which will be assessed by asking the patient or relative.
- Patients with hypotension(\<90/60mmHg).
- Pregnant and breast feeder female patients.
- Hepatic patients.
- Patients already receiving chlorpromazine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Noha Mahmoud Nasreldin Hassancollaborator
Study Sites (1)
Cairo University
Cairo, 11562, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Rezk
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Instructor
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 21, 2020
Study Start
August 1, 2020
Primary Completion
October 1, 2020
Study Completion
November 1, 2020
Last Updated
July 8, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- September 2020 to December 2020
- Access Criteria
- Direct contact with the investigator