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
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Chlorpromazine Injection||Phase 1 Phase 2|
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:
- Lactate dehydrogenase (LDH).
- The lymphocyte count.
- C-reactive protein (CRP).
- Arterial Blood gases for Patients on Ventilators only.
- The change in patients clinical manifestation [ Time Frame: up to 3 weeks ] (Mild, Moderate or Severe).
- Polymerase chain reaction (PCR).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|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|
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.
- 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.
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
|Contact: Ahmed Nasreldin Rezk||1118080934 ext email@example.com|
|Contact: Noha Rezk||1099433863 ext firstname.lastname@example.org|
|Cairo, Egypt, 11562|
|Contact: Ahmed Rezk 1118080934 ext 0020 email@example.com|
|Principal Investigator:||Ahmed Rezk||Cairo University|