Evaluation of the effect of Levamisole on treatment of the patients with COVI-19 infection
Design
In this study every patient with diagnosis of COVID-19 and with sign and symptoms will be selected and will randomized in control and interventional groups. 20 patients will be selected with mild, moderate and sever condition (overall 60) and in every condition group 10 patients, will be randomized with block randomization method in control and interventional groups.
Settings and conduct
After randomzation, in interventional group levamizole 50 mg daily for 14 days will be administered in addition to standard therapy and in control group only standard therapy will be administered.
Participants/Inclusion and exclusion criteria
the patients with COVID 19 infection
Intervention groups
In this study the selected patients will be setelled into two groups . in interventional group levamizole will be administered and in the control group any drug will be given,
Main outcome variables
clinical status, Blood O2 saturation, Hemodynamic state
General information
Reason for update
Acronym
لوامیزول
IRCT registration information
IRCT registration number:IRCT20181208041886N1
Registration date:2020-10-18, 1399/07/27
Registration timing:prospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Morteza Pourahmad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3322 0197
Email address
mortezapourahmad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-17, 1399/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of levamizole on treatment of patients with COVID 19 infection: a controlled clinical trial study.
Public title
Levamizole in treatment of COVID19.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age =or > 18 years
Diagnosis of COVID19 infection was made by positive test for RtPCR on nasopharyngeal swab, Lung HRCT and the opinion of infectious diseases specialist.
informed consent of patient for study
the possibility of patient follow up.
Exclusion criteria:
Another cause for signs and symptoms
hypersensitivity to levamizole
consumption of other antibiotics on the neck.
Dyspnea
Pregnancy
breat feeding
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The selected patients on inclusion and exclusion criteria will be randomized in two experimental and control groups in 15 randomized block. In every block 4 patients will be setelled (2 patient as control and 2 as interventional). At first the physician will visit the patients and on the clinical criteria he/she decided that the disease is mild, moderate and / or sever and the patient will setelled in the blocks and groups (control or interventional).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the patients and the physician who evaluate the signs and symptoms of the patients are blinded about the therapy. To prevent of the bias the levamizole tablet will be give the patients accompanied with other drugs. On the other hand the assessor also will not be informed about the drugs of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
nothing
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
improvement of the patient which has had COVOD-19>
Timepoint
14 days
Method of measurement
evaluation of the patient by a physician
Intervention groups
1
Description
Intervention group: the patients with diagnosis of COVID19 with be treated by tablet Levamisole 50 mg daily for 14 days in addition to standard therapies for these patients. the sign and symptoms of the patients will be evaluated daily.
Category
Treatment - Drugs
2
Description
Control group: the patient with diagnosis of COVID19 will give the standard therapies and without Levamisole.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Morteza Pourahmad
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3322 0996
Fax
Email
mortezapourhamad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ِDr. Shaghayegh Haghjoo, Research assistant of Isfahan University of Medical Sciences
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3792 3078
Email
shaghayegh.haghjoo@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research assistant of Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Morteza Pourahmad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3322 0996
Email
mortezapourahmad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Morteza Pourahmad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Sofe Street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3322 0996
Email
mortezapourahmad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Morteza Pourahmaed
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3322 0996
Email
mortezapourahmad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
the article from this study will be distributed
the effect of Levamisole on treatment of COVID 19 infection
When the data will become available and for how long
immediately after article publish
To whom data/document is available
Every body
Under which criteria data/document could be used
no condition
From where data/document is obtainable
published article
What processes are involved for a request to access data/document