Evaluation of the Effect of Trifluoperazin in Treatment of Patients with Confirmed 2019 Novel Coronavirus(COVID- 19): An Open-Label Randomized Clinical Trial
Evaluation the effect of Trifluoperazine in treatment of patients with confirmed COVID- 19
Design
Clinical trial with control group with parallel, Open labeled, Randomised
Settings and conduct
Clinical trials will be conducted at the Valiasr Medical-Educational Center affiliated to Birjand University of Medical Sciences on approved COVID-19 patients. Patients are treated in two groups. The study will be performed at the beginning of hospitalization.
Participants/Inclusion and exclusion criteria
Inclusion and exclusion criteria in study:
Patients who have been confirmed with the Real Time PCR test for COVID-19 disease or patients who show evidence of lung involvement on CT scans.
The desire to participate in the study
Age over 12 years
Hospitalization in the department dedicated to patients with COVID-19
Lack of confirmed allergy to triflurpazine
Absence of liver disease
Over 65 years of age if dementia-related psychosis is not present
Lack of viral and bacterial infections
Absence of pregnancy in women
Patients with benign prostatic hyperplasia
Patients with intestinal obstruction
Patients with blood disorders and bone marrow disorders
Patients with severe central nervous system weakness or coma
Intervention groups
Control group:Patients treated with hydroxychloroquine and, if necessary, according to the approved treatment protocol, kaletra and ribavirin are added to the treatment.
Case group:In addition to treating hydroxychloroquine, trifluoprazine is given at a dose of 2 mg twice daily for 14 days. In this group, if necessary, according to the approved treatment protocol, Kaletra and ribavirin are added to the treatment.
Main outcome variables
Determination of therapeutic effects of trifluoprazine in patients with COVID19:
-Respiratory function of the lungs.
-Reducing the patient's inflammatory responses.
-Reduction of the patient's hospitalization period.
-Reduce mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046992N1
Registration date:2020-04-14, 1399/01/26
Registration timing:prospective
Last update:2020-04-14, 1399/01/26
Update count:0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Kazem Dastjerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2639
Email address
dastjerdi1974@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-16, 1399/01/28
Expected recruitment end date
2020-07-18, 1399/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Trifluoperazin in Treatment of Patients with Confirmed 2019 Novel Coronavirus(COVID- 19): An Open-Label Randomized Clinical Trial
Public title
Effect of Trifluoperazine in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with laboratory-confirmed COVID 19 infection with Real Time PCR and patients with evidence of lung involvement in CT Scan
Willing to provide informed consent
Age older than 12 years.
Patients admitted to specialized COVID-19 ward
Patients without Known severe allergy to trifluoperazine perazin and other phenothiazines such as cholorphenothiazines
Patients older than age 65 years are included if they do not suffer from Dementia-Related Psychosis
Exclusion criteria:
Patient With a Liver Disorder
Patients with bacterial or viral infection
Pregnant women
Patients with benign prostatic hyperplasia (BPH)
Patients with intestinal obstruction
Patients with blood disorders or bone marrow failure
Coma patients and patients with central nervous system weakness
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand,
City
birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.BUMS.REC.1399.004
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
Pneumonia due to SARS-associated coronavirus
Primary outcomes
1
Description
Determining the efficacy of trifluoprazine in improving the Clinical manifestations of patients with confirmed COVID-19 infection by recording the patient's clinical parameters including 7 clinical parameters of respiration number, Blood Oxigen Saturation, oxygen support, temperature, heart rate, systolic blood pressure and Awareness level, assessment of lung involvement with Chest CT-Scan, measurement of c-reactive protein on treatment days, measurement of CBC indicators and biochemical factors such as urea and creatinine
Timepoint
Check of the patient's clinical condition and blood sampling of patients on days 1-14 in the hospital and also on the 28th day after the onset of the disease
Method of measurement
Measuring CBC indicators and biochemical factors using an autoanalyzer and examining heart function using EKG,Measurement of other factors using a thermometer and blood pressure monitor and patient bedside examinations.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:35 participants in the investigational treatment group will receive trifluoprazine at a dose of 5 mg twice daily for 14 days on admission in addition to standard treatment consisting of hydroxychloroquine. If necessary, according to the approved treatment protocol, kaletra and ribavirin would be added to the treatment
Category
Treatment - Drugs
2
Description
Control group:35 participants in control group, would receive standard treatment protocol consisting hydroxychloroquine and , if necessary, according to the approved treatment protocol, kaletra and ribavirin would be added to the treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital , Infectious Disease Clinic
Full name of responsible person
Dr Masood Ziaee
Street address
Birjand University of Medical Sciences , Ghafari Street,
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 5000
Email
dr.m.ziaee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Ghafari Street, Birjand, Southern Khorasan, Iran.
City
Brijand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Masood Ziaee
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ghafari Street,
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Fax
Email
dr.m.ziaee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Kazem Dastjerdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Building No 56, Edaalat 4, Birjand
City
Birjand
Province
South Khorasan
Postal code
9718673131
Phone
+98 56 3243 2639
Fax
Email
dastjerdi1974@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Motahareh Mahi-Birjand
Position
Post-board Resident
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, Southern Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
motahare_mahi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available