Protocol summary

Study aim
1. Detection effect of Montelukast on disease improvement and inflammatory factors in patients with COVID-19 2. Detection effect of Montelukast on duration of hospitalization, changes of interleukin 1 and 6 levels in serum, cough, and oxygen saturation level
Design
Two arm parallel groups randomized trial with blinded care and outcome assessment. Randomization: 2 groups A & B
Settings and conduct
The current study will carry in Ayatollah Rohani hospital -Babol-Iran during 2020. All patients will give standard treatment of COVID-19 disease but test group will take Montelukast (Airokast, Abidi) at dose 10mg per day for at least 10 days along with standard regimen. blood sample will collect at beginning and end of study. The demographic data, fever, coughو and oxygen saturation will record . biochemical and inflammation markers such as CBC,CRP,LDH, ESR, ALB, TNFα, IL-1, and IL-6 in serum will measure by kits. Lung ct-scan and duration of hospitalization will record.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-All hospitalized patients with confirmed COVID-19 at both gender and 18-90 ages include in this study 2-All hospitalized patients with confirmed COVID-19 without other severe disease 3-Patient consent Exclusion criteria: 1-Patients with suspected COVID-19 2-History of allergy to Montelukast 3-lack of cooperation from the patient
Intervention groups
114 patients with COVID-19 will divide two groups (57 patients each group): group1: standard regimen; group2: standard regimen+ Montelukast
Main outcome variables
Primary outcomes:CBC,CRP,LDH وESR و ALB و IL-1,IL-6

General information

Reason for update
Acronym
MLK
IRCT registration information
IRCT registration number: IRCT20180624040213N2
Registration date: 2020-09-14, 1399/06/24
Registration timing: registered_while_recruiting

Last update: 2020-09-14, 1399/06/24
Update count: 0
Registration date
2020-09-14, 1399/06/24
Registrant information
Name
Hossein Najafzadehvarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3247 6421
Email address
h.najafzadeh@mubabol.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-07-21, 1399/04/31
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Montelukast on inflammatory factors in patients with COVID-19
Public title
Montelukast in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All hospitalized patients with confirmed COVID-19 at both gender and 18-90 ages include in this study All hospitalized patients with confirmed COVID-19 without other severe disease Patient consent
Exclusion criteria:
Patients with suspected COVID-19 History of allergy to Montelukast lack of cooperation from the patient
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
blocking Randomization & Concealment (A&B groups)
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding: single blind and open label
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz street, Kargar squer, Babol
City
Babol
Province
Mazandaran
Postal code
4774547176
Approval date
2020-07-01, 1399/04/11
Ethics committee reference number
IR.MUBABOL.REC.1399.222

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19 disease

Primary outcomes

1

Description
Change of interleukin levels
Timepoint
Beging of study and 10 days later
Method of measurement
With ELISA kit

Secondary outcomes

1

Description
Fever
Timepoint
During of study (10 days)
Method of measurement
Scoring (mild, moderate, sever)

2

Description
Cough
Timepoint
During of study (10 days)
Method of measurement
Scoring (mild, moderate, sever)

3

Description
Blood oxygen saturation
Timepoint
During of study (10 days)
Method of measurement
Percentage of blood oxygen

Intervention groups

1

Description
Test group: treatment with standard regimen along with Montelukast (current drugs for COVID-19 treatment such as Caletra and supportive treatment+ Montelukast at dose 10mg per day for at least 10 days)
Category
Treatment - Drugs

2

Description
Control group: standard regimen of COVID-19((current drugs for COVID-19 treatment such as Caletra and supportive treatment)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
َAyatollah Rohani hospital
Full name of responsible person
Hossein Najafzadehvarzi
Street address
Babol University of Medical Sciences, Ganjafrooz street, Kargar squer, Babol
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9936
Email
najafzadehvarzi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol university of medical sciences, Ganjafrooz street, Kargar squer, Babol
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9936
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Hossein Najafzadehvarzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Medical faculty, Babol University of Medical Sciences, Ganjafrooz street, Kargar squer, Babol
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9936
Email
najafzadehvarzi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hossein Najafzadehvarzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Medical faculty, Babol University of Medical Sciences, Ganjafrooz street, Kargar squer, Babol
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9936
Email
najafzadehvarzi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hossein Najafzadehvarzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Medical faculty, Babol University of Medical Sciences, Ganjafrooz street, Kargar squer, Babol
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9936
Email
najafzadehvarzi@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
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
Primary data will present
When the data will become available and for how long
6 months after publication
To whom data/document is available
Data will be available for scientific and academic proposes
Under which criteria data/document could be used
Data will take for scientific proposes by an allowance of the medical sciences university of Babol.
From where data/document is obtainable
Return to the medical sciences university of Babol.
What processes are involved for a request to access data/document
Data will take by an allowance of the medical sciences university of Babol.
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