Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Administration of Chlorpromazine as a Treatment for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354805
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
Noha Mahmoud Nasreldin Hassan
Information provided by (Responsible Party):
Ahmed Rezk, Cairo University

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Chlorpromazine Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single centred, single-blinded randomised controlled trial. All subjects from a population of interest will be randomly assigned to one of two groups, one group who is exposed to the intervention or a second group who receive the routine care in the hospital.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Administration of Chlorpromazine as a Treatment for COVID-19
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
The 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.
Drug: Chlorpromazine
(Oral dose of 50 mg/ day for 3 days then doubled to 100mg/day for further 11 days)
Other Name: Neurazine, Largactil

No Intervention: Group B
A group of 50 patients control group who will recieve only the convential treatment of COVID-19 according to the Egyptian Ministry of Health protocol.



Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 2 weeks ]

    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult conscious male and female (non-pregnant, non-breast feeder), level of consciousness is assessed by Glasgow Coma Scale ≥ 13.
  2. Diagnosed initially with COVID-19 confirmed with PCR prior to any interference.
  3. Follow the treatment regimen for COVID-19 according to The Ministry of Health in Egypt.

    Exclusion criteria:

  4. Patients having allergy to chlorpromazine which will be assessed by asking the patient or relative.
  5. Patients with hypotension(<90/60mmHg).
  6. Pregnant and breast feeder female patients.
  7. Hepatic patients.
  8. Patients already receiving chlorpromazine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354805


Contacts
Layout table for location contacts
Contact: Ahmed Nasreldin Rezk 1118080934 ext 0020 ahmed.nasr@cu.edu.eg
Contact: Noha Nasreldin Hassan 1099433863 ext 0020 noha.m.nasreldin@students.kasralainy.edu.eg

Locations
Layout table for location information
Egypt
Cairo University
Cairo, Egypt, 11562
Contact: Ahmed Rezk    1118080934 ext 0020    ahmed.nasr@cu.edu.eg   
Sponsors and Collaborators
Cairo University
Noha Mahmoud Nasreldin Hassan
Investigators
Layout table for investigator information
Principal Investigator: Ahmed Rezk Cairo University
Layout table for additonal information
Responsible Party: Ahmed Rezk, Clinical Instructor, Cairo University
ClinicalTrials.gov Identifier: NCT04354805    
Other Study ID Numbers: Medical
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Time Frame: September 2020 to December 2020
Access Criteria: Direct contact with the investigator

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Chlorpromazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action