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Administration of Chloropromazine 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 : April 21, 2020
Sponsor:
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 IV injection. 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 Injection Phase 1 Phase 2

Detailed Description:

Background:

Coronaviruses (CoVs) primarily cause enzootic infections in birds and mammals but, in the last few decades, have shown to be capable of infecting humans as well. The viral Covid-19 outbreak is currently considered a pandemic according to the World Health Organisation (WHO). COVID-19 integration to the host cells requires active function of lysosome with a pH value from 4 to 5. This is the suitable PH for the bio-chemical reactions thats ends with removal of the viral protein envelope and freedom of the viral genetic material for replication.

Chlorpromazine is an antagonist of the dopamine receptor D2 (DRD2) and has been effectively and safely employed for over half a century in the treatment of psychiatric disorders. The potential efficacy of Chlorpromazine as a treatment for COVID-19 depends on the ability of Chlorpromazine to increase the pH of lysosome. This will deprive the COVID-19 to set its genetic material free for further replication.

Aim of the study:

This study aims to evaluate the effect of administration of the Chlorpromazine on COVID-19 patients.The improving clinical outcomes and reducing the need for ventilator support will be evaluated in treated patient compared to control group. Approximately 60 participants hospitalized with COVID-19 in Cairo University hospitals will be enrolled into this study.

Materials and methods:

  • Consents are collected from control and study group according to the ethical regluations.
  • Intra-venous administration of Chlorpromazine, a dose of 25 mg every 6 hours for duration of 1 week.
  • Evaluation will be done through monitoring:

    1. Lactate dehydrogenase (LDH).
    2. The lymphocyte count.
    3. C-reactive protein (CRP).
    4. Arterial Blood gases for Patients on Ventilators only.
    5. The change in patients clinical manifestation [ Time Frame: up to 3 weeks ] (Mild, Moderate or Severe).
    6. Polymerase chain reaction (PCR).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Quasi-Experimental pre/post test nonequivalent, interrupted, control group design will be utilized in the current study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Administration of Chloropromazine as a Treatment for COVID-19
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
The group of 30 patients are going to receive 25 mg Chlorpromazine every 6 hours for 1 week in addition to the convential treatment of COVID-19 according to the Egyptian Ministry of Health protocol.
Drug: Chlorpromazine Injection
An intravenous administration of 25 mg Chloropromazine every 6 hours for 1 week .
Other Name: Neurazine

No Intervention: Group B
A group of 30 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. Lactate dehydrogenase (LDH) [ Time Frame: 2 weeks ]
    LDH is an enzyme indicate some form of tissue damage, Normal LDH levels range from 140 units per litre (U/L) to 280 U/L.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • COVID-19 Adult patients

Exclusion Criteria:

  • Age less than 18 years.
  • Previous history of allergy to 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
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Contact: Ahmed Nasreldin Rezk 1118080934 ext 0020 ahmed.nasr@cu.edu.eg
Contact: Noha Rezk 1099433863 ext 0020 drnoha92@gmail.com

Locations
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Egypt
Cairo University
Cairo, Egypt, 11562
Contact: Ahmed Rezk    1118080934 ext 0020    ahmed.nasr@cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Rezk Cairo University
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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: April 21, 2020
Last Verified: April 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

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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:
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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