Evaluation of efficacy of pharmacotherapy treatment of COVID- 19 infection using oral Levamisole and Formoterol+Budesonide inhaler and comparison of this treatment protocol with standard national treatment of the disease
A- Finding effective and available treatment for COVID-19 patients
B- Comparison of our treatment protocol with national standard, treatment protocol
Design
Two arm, parallel group, randomized double blind clinical trial
Settings and conduct
Hospitalized COVID-19 positive patients will be randomly divided into two groups of 15 patients in Vali Asr hospital of Fasa, One group will be test group and another will be control group according to the medical ethics guidelines.
Participants/Inclusion and exclusion criteria
All of the COVID-19 hospitalized patients with positive PCR and Chest CT-scan
Intervention groups
Control group will take national standard treatment medicines and test group will take Levamisole tablet 50 mg TDS and Budesonide+ Formoterol inhaler 1 puff every 12 hours as intervention drugs in addition to standard treatment. Standard treatment consists of Hydroxychloroquine equal to 400 mg in a single dose and Kaletra (Lopinavir / Ritonavir) 200/50 mg two tablets every 12 hours.
Both groups will take standard treatment but in test group intervention drugs will be added.
Main outcome variables
Main variables are elimination of sign of disease like Cough, Fever and dyspnea. Elimination of Lymphopenia and negative result of PCR and chest CT-scan are other expected result of intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200324046852N1
Registration date:2020-04-05, 1399/01/17
Registration timing:registered_while_recruiting
Last update:2020-04-05, 1399/01/17
Update count:0
Registration date
2020-04-05, 1399/01/17
Registrant information
Name
Siamack Afazeli
Name of organization / entity
Nivan pharmed pharmaceutical Company
Country
Iran (Islamic Republic of)
Phone
+98 21 6647 5335
Email address
dr.afazeli@nivanpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-01, 1399/01/13
Expected recruitment end date
2020-04-13, 1399/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of pharmacotherapy treatment of COVID- 19 infection using oral Levamisole and Formoterol+Budesonide inhaler and comparison of this treatment protocol with standard national treatment of the disease
Public title
Comparison of efficacy of oral Levamisole and Formoterol+Budesonide inhaler with standard treatment of Corona infection.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 positive patients with positive, PCR and chest CT scan
Exclusion criteria:
Patients with sever respiratory problems including patients with:1. Spo2<60%2. Severe respiratory distress3. Heamodynamic instabilitty 4. Acid base disturbance 5. Severe Anemia
Patients with hepatic diseases
Patients with Nervous system diseases
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be selected by the clinician. Each patient will be assigned an alphabetical code, a list of codes will be sent to the researcher. The researcher coded the codes from the random number table and assigned a new numeric code to each patient for each test and control group. These numerical codes will be used to form patient records and place the patient in the designed group.
Blinding (investigator's opinion)
Double blinded
Blinding description
All of the research team will be blind about the groups of study and position of patients in each group except of physician and main researcher. Files of patients which will be numbered using a random number table will be sent for analyzer of the study. Information about position of patients in the groups is masked from research team. Outcomes Assessor will receive the information of patients without any name in the file. Just when statistical analysis would be finished information of groups will be revealed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Fasa University of Medical Sciences
Street address
Fasa University of Medical Sciences, Ebne sina Sq.
City
Fasa
Province
Fars
Postal code
86688 - 74616
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.FUMS.REC.1399.002
Health conditions studied
1
Description of health condition studied
Corona virus infection
ICD-10 code
U07.1
ICD-10 code description
COVID-19, confirmed by laboratory testing
Primary outcomes
1
Description
Chest CT-Scan response to treatment including dispersion size of Ground Glass area, bronchitis and consolidation.
Timepoint
Days 0-3-7
Method of measurement
CT scan apparatus
2
Description
Response to treatment in Lymphocytes count.
Timepoint
Daily
Method of measurement
By apparatus in diagnostic lab.
3
Description
Response to treatment for COVID-19 specific PCR test
Timepoint
Days 0-3-7
Method of measurement
Using PCR apparatus
4
Description
Response to treatment in O2 level and CO2 level in ABG or VBG test
Timepoint
Daily
Method of measurement
By apparatus in diagnostic lab.
Secondary outcomes
1
Description
Blood pressure response to treatment
Timepoint
daily
Method of measurement
By Sphygmomanometer
2
Description
Creatinine level during intervention
Timepoint
Daily
Method of measurement
By apparatus in diagnostic labs.
3
Description
Level of CRP ( C reactive protein) in response to intervention
Timepoint
Daily
Method of measurement
By apparatus in diagnostic labs.
Intervention groups
1
Description
Intervention group:In this group along with the standard drugs according to the national guideline of treatment for COVID-19, patients will take Levamisole 50 mg TDS for 3-7 days, made by Poursina pharmaceutical Company and Budesonide+Formoterol 1 Puff every 12 hours made by Astra Zenca Company for 3-7 days. Brand name of Budesonide+Formoterol is Symbicort and it has two strength ; 160/4.5 and 320/9 mcg respectively. Decision about the used strength and dose of drug depends on the situation of the disease and will be made by physician.
Category
Treatment - Drugs
2
Description
Control group: This group just take standard drugs consist of Kaletra and Hydroxychloroquie. This national protocol would be taken as below: 1- Hydroxychloroquine sulfate 200 mg as a single dose. 2- Kaletra tablet ( Lopinavir/ Ritonavir) 200/50 mg 2 tablets every 12 hoursfor atleast 5 days which can be extended to 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Dr. Jalal Karimi
Street address
Ebne Sina Square
City
Fasa
Province
Fars
Postal code
86688 - 74616
Phone
+98 71 5331 5026
Email
info@fums.ac.ir
Web page address
http://www.fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjaam
Street address
Ebne Sina Square
City
FASA
Province
Fars
Postal code
86688 - 74616
Phone
+98 71 5335 0994
Email
farjam.md@gmail.com
Web page address
http://www.fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Dr. Siamack Afazeli
Position
consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Unit704, No 372, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416894438
Phone
+98 21 6647 5335
Email
dr.afazeli@gmail.com
Web page address
https://nivanpharmed.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.Siamack Afazeli
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 704, No. 372, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416894438
Phone
+98 21 6647 5335
Email
Dr.afazeli@gmail.com
Web page address
https://nivanpharmed.com/
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Siamack Afazeli
Position
consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Unit704, No 372, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416894438
Phone
+98 21 6647 5335
Email
dr.afazeli@gmail.com
Web page address
https://nivanpharmed.com/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Just some part of data which is deductible for health care staff will be shared.
When the data will become available and for how long
From the 17th of April till 17th of June 2020
To whom data/document is available
Just for medical proffesionals and managers of Ministry of health
Under which criteria data/document could be used
Following to written approval of Research deputy of Fasa University of medical sciences
From where data/document is obtainable
Research deputy of Fasa University of medical sciences
What processes are involved for a request to access data/document
By correspondence with the research deputy of the University and after approval requested data will be sent.