Evaluation of efficacy and safety of adding Chlorpromazine to Atazanavir/Ritonavir regimen in the treatment of COVID-19 patients, a randomized double-blind clinical trial
Evaluation of efficacy and safety of adding chlorpromine to Atzanavir/Ritonavir in treatment of admitted patients with covid-19 infection, in order to find the better and safer treatment for this lethal infection.
Design
Randomized parallel group trial with blinded outcome assesment on 100 patients,.Randomization will be done with a 5 digit code from excell software .
Settings and conduct
Patients will be allocated into two groups based on block randomization.Using the Excel software, a 5-digit code will be assigned to each patient. Study drugs will be placed in similar envelopes and patients, physicians and evaluators will not be aware of the type of intervention received. One group will receive atazanavir/ritonavir 300/100 once daily and 25 mg chlorpromazine Three times a day and the other group will receive atazanavir ritonavir 300/100 once daily with 3 doses of placebo for up to 14 days.
Participants/Inclusion and exclusion criteria
the patients with covid 19 infection who admitted in one of university afiliated hospital of Mazandaran University of Medical Sciences,based on clinical findings consistent with covid 19 and confirmed with Rt-PCR or lung Ct findings.
treaement regimen consisting of Atazanavir /Ritonavir
Spo2 < 93% in room air
ages >18 years
Intervention groups
En Intervention group: َAtazanavir Ritonavir 300/100 mg once daily and Chlorpromazine 25 mg three times daily up to maximum 14 days
Control group: Atazanavir Ritonavir 300/100 mg once daily and placebo three times daily up to maximum 14 days
Main outcome variables
Primary outcome: Daily Spo2
Secondary outcomes: need to ICU admission, admission length in the ICU, admission length in the hospital, mortality rates
General information
Reason for update
Acronym
CIC
IRCT registration information
IRCT registration number:IRCT20200913048708N1
Registration date:2020-10-01, 1399/07/10
Registration timing:prospective
Last update:2020-10-01, 1399/07/10
Update count:0
Registration date
2020-10-01, 1399/07/10
Registrant information
Name
roya ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3337 8840
Email address
royaghasemian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-31, 1399/08/10
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of adding Chlorpromazine to Atazanavir/Ritonavir regimen in the treatment of COVID-19 patients, a randomized double-blind clinical trial
Public title
Efficacy and safety of Chlorpromazine in the treatment of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all admitted patients with covid -19 infection based on clinical findings ,PCR or lung CT abnormality consistent with covid-19
spo2 bellow 93 mmHg
age above 18 years old
Exclusion criteria:
patient rejection
history of antipsycotic use
history of seizure, dementia and parkinson disease
Hx of liver disease
Hx of feochromocytoma
allergy to phenothiazines drug
any drug interaction between patients medicines and chlorpromazine
pregnancy and lactation
Hx of covid treatments
bradycardia < 60 /min
multi-organ failure
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using block randomization. 5-digits’ codes will be obtained by Excel program and patients will be randomly assigned to intervention and control groups. Each randomization unit will be a block of six blocks including 4 patients in each block (AABB, ABBA, ABAB, BBAA, BAAB and BABA). The sequence of blocks will be determined with a dice that numbers of 1 to 6 written on it. Allocation concealment will be carried out through inserting the study drugs in matt containers with identical appearance and 5 digits’ codes written on it.
Blinding (investigator's opinion)
Double blinded
Blinding description
A separate 5-digit code obtained from the computer will be assigned to each patient.The intervention, including the drug or placebo, will be placed in identical containers, and the senior researcher will insert the code on the containers. The researcher and patient will not be aware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Mazandaran University of Medical Sciences
Street address
Number 8, Shahid moini ave , Amir mazandarani Street , Sari, Iran
City
Sari
Province
Mazandaran
Postal code
48168-13393
Approval date
2020-08-12, 1399/05/22
Ethics committee reference number
IR.MAZUMS.REC.1399.617
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Patients level of Spo2
Timepoint
daily
Method of measurement
puls oximetr
Secondary outcomes
1
Description
Need to ICU admission
Timepoint
During the study
Method of measurement
Follow up of patient and documentation of the ICU admission
2
Description
Days stayed in the Intensive Care Unit
Timepoint
During the study
Method of measurement
Documenting the days stayed in the Intensive Care Unit
3
Description
Days stayed in the hospital
Timepoint
At the end of the study
Method of measurement
Documentation of the hospital stay according to patients chart
4
Description
Mortality rate
Timepoint
At the end of the study
Method of measurement
Follow up of patients and documentation of the mortality
Intervention groups
1
Description
Intervention group: Patients with covid 19 infection will receive standard treatment of Atazanavir/Ritonavirdrug 300/100 mg (Razavi Pharmaceutical Institute) once daily in addition to chlorpromazine 25 mg (Tehran Shimi Company) three times a day. Maximum time of intervention will be 14 days.
Category
Treatment - Drugs
2
Description
Control group: Patients with covid 19 infection will receive standard treatment of Atazanavir/Ritonavirdrug 300/100 mg (Razavi Pharmaceutical Institute) once daily in addition to Placebo three times a day. Maximum time of intervention will be 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital, Sari
Full name of responsible person
Roya Ghasemian
Street address
n.8, Shahid Moini ave, Amir mazadarani street, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
48168-13393
Phone
+98 11 3337 9692
Email
roya31gh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid saeedi
Street address
Research and Technology Deputy, Moallem Square
City
Sari
Province
Mazandaran
Postal code
48168-13393
Phone
+98 11 3337 9692
Email
Majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
15 Khordad street -Mahdieh 7 ave
City
Sari
Province
Mazandaran
Postal code
4818893716
Phone
+98 11 3340 6746
Email
Esalehifar52@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Ghasemian
Position
Associate proffessor of infectious disease
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
No 8 street
City
Sari
Province
Mazandaran
Postal code
48168-13393
Phone
+98 11 3337 9692
Email
roya31gh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Ghasemian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
No 8 Street
City
Sari
Province
Mazandaran
Postal code
48168-13393
Phone
+98 11 3337 9692
Email
roya31gh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of patients data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available