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Effectiveness of Ivermectin in the Treatment of Coronavirus Infection in Patients admitted to Educational Hospitals of Mazandaran in 2020

Protocol summary

Study aim
Determining the effectiveness of Ivermectin in the treatment of Covid-19 infection in hospitalized patients in Mazandaran educational hospitals in 2020
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. Study patients are divided into two groups by simple randomization method with random number table. The control group will receive the standard treatment and the intervention group will receive a single dose of Ivermectin in addition to the standard treatment.
Settings and conduct
Patients with coronavirus hospitalized in Mazandaran educational hospitals are randomly divided into two groups of intervention and control. The present study is double-blind so that patients and the care provider will be unaware of how the intervention and control group is allocated.
Participants/Inclusion and exclusion criteria
Patients with suspected Covid-19 hospitalized over the age of 5 years and weight more than 15 kg will be included in the study if they are satisfied.
Intervention groups
In the intervention group, along with the standard drugs of the national protocol for the treatment of coronavirus infection, a single dose of Ivermectin 3 mg oral tablet with a dose of 0.2 mg/kg of Tadbir Kala Jam Company will be used according to the following : weight 15-24, 3 mg ; Weight 25-3, 6 mg; Weight 36-50, 9 mg; Weight 51-80, 12 mg and weight over 80, 0.2 mg/kg
Main outcome variables
Clinical symptoms including fever, chills, sore throat, cough, shortness of breath, decreased appetite, abdominal pain, dizziness, insomnia, itching, joint pain, joint swelling, headache, nausea, vomiting, diarrhea, malaise, conjunctivitis, tachycardia, wheezing, rhonchus, retraction, hypotension, rash, other symptoms, and respiratory rate and O2 saturation will be recorded in first, second, third, fourth, fifth, sixth, seventh day.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111224008507N3
Registration date: 2020-06-27, 1399/04/07
Registration timing: registered_while_recruiting

Last update: 2020-06-27, 1399/04/07
Update count: 0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Mohammadsadegh Rezai
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 7230
Email address
rezai@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Ivermectin in the Treatment of Coronavirus Infection in Patients admitted to Educational Hospitals of Mazandaran in 2020
Public title
Evaluation of the effect of Ivermectin in the treatment of coronavirus infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients hospitalized with suspected Covid-19 Informed consent for inclusion in study Age above 5 years Weight above 15 kg
Exclusion criteria:
Liver and kidney disease Patients with acquired immunodeficiency Consumption of warfarin and ACEI family drugs (captopril, enalapril, etc.) Breastfeeding
Age
From 5 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control with 33 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the samples, none of the participant will be aware of randomization and allocation to groups. The evaluator nurse of data recording is from out of the study and questionnaires will be provided in the form of coding to him/her. So, the present study is double-blinded.
Placebo
Not 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
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.MAZUMS.REC.1399.057

Health conditions studied

1

Description of health condition studied
COVID-19 infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Clinical symptoms including fever, chills, sore throat, cough, shortness of breath, decreased appetite, abdominal pain, dizziness, insomnia, itching, joint pain, joint swelling, headache, nausea, vomiting, diarrhea, malaise, conjunctivitis, tachycardia, wheezing, rhonchus, retraction, hypotension, rash, other symptoms
Timepoint
The first, second, third, fourth, fifth, sixth, seventh day
Method of measurement
Observation and record in checklist

2

Description
Respiratory rate and O2 saturation
Timepoint
The first, second, third, fourth, fifth, sixth, seventh day
Method of measurement
Pulse Oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In the control group, only standard drugs of the national protocol are used.
Category
Treatment - Drugs

2

Description
Intervention group: In the intervention group, along with the standard drugs of the national protocol, a single dose of 3 mg Ivermectin oral tablet with a dose of 0.2 mg/kg of Tadbir Kala Jam Company will be used according to the following table: weight 15-24, 3 mg; Weight 25-35, 6 mg; Weight 36-50, 9 mg; Weight 51-80, 12 mg and weight over 80, 0.2 mg/kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Teaching hospitals of Mazandaran
Full name of responsible person
Modammad Sadegh Rezai, MD
Street address
Bouali Hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
drmsrezaii@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi
Street address
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
47128-55689
Phone
+98 11 3334 2334
Email
msaidi@mazums.ac.ir
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
Dr. Mohammad Sadegh Rezai
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Bouali Hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
drmsrezaii@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammadsadegh Rezai
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Bouali Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
drmsrezaii@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Hosseinzadeh
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bouali Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
fatima.hzade@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data is available
When the data will become available and for how long
Starting in January 2021
To whom data/document is available
All people
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Contact Dr. Mohammad Sadegh Rezai. E-mail: drmsrezaii@yahoo.com
What processes are involved for a request to access data/document
After contact, information is sent within a few days
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