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Evaluation of treatment regimen containing beta-1-b interferon on the COVID-19 patients with mild and severe symptoms and comparing it with interferon-free treatment regimen

Protocol summary

Study aim
evaluation of the effect of treatment regimen contains Intrefron beta-1-b on the Covid 19 patients compared with those patients who received treatment regimen without interfron.
Design
Open label, controlled and paralleled non-randomized clinical trial with control group phase 2-3 on 150 patients as two intervention and control groups.
Settings and conduct
Sampling for arterial oxygen pressure and other blood sample parameters (LDH, ESR,, CBC, D-dimer, Lymphocyte and neutrophil absolute count) will be measured at the beginning of hospitalization and the end of treatment course. Severity of lung involvement assessed by CT scan of chest. This study will be held on the patient hospitalized in Shahid Mohammadi hospital, Bandar Abbas, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive real time PCR test from nasopharyngeal and oropharyngeal swabs, Degree of lung involvement by CT-severity scoring, Arterial Po2 pressure less than 93 mmHg, and respiratory rate more than 30 times/min. Exclusion criteria: Chronic diseases like diabetes, asthma, cardiovascular disorder, Malignancy and other condition like pregnancy, breastfeeding and corticosteroid therapy.
Intervention groups
90 patients will be selected as an intervention group and 50 patients as a control group. The intervention group will be received routine treatment regimen plus Interferon beta-1-b and control group will be received routine regimen only.
Main outcome variables
CRP - LDH - ESR - WBC - Neutrophil count-Lymphocyte count- D-dimer - CT severity score- Po2 -

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201001048894N1
Registration date: 2020-12-15, 1399/09/25
Registration timing: registered_while_recruiting

Last update: 2020-12-15, 1399/09/25
Update count: 0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Afshin Samiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3371 0373
Email address
afshin.samiei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of treatment regimen containing beta-1-b interferon on the COVID-19 patients with mild and severe symptoms and comparing it with interferon-free treatment regimen
Public title
Effect of Interferon beta-1-b on COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive result of Real time PCR CT severity scoring P o2 < 93mmHg Respiratory rate more than 30 time per minute.
Exclusion criteria:
Diabetes Cardiac diseases pregnancy Malignancy Consumption of corticosteroids
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Hormozgan University of Medical Sciences
Street address
Emam Hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Approval date
2020-08-15, 1399/05/25
Ethics committee reference number
IR.HUMS.REC.1399.259

Health conditions studied

1

Description of health condition studied
Covid 19
ICD-10 code
U07.1
ICD-10 code description
Covid 19 , Virus Identified

Primary outcomes

1

Description
CT severiity score
Timepoint
At the beginning and the end of study
Method of measurement
By CT scan

2

Description
ABG - Pao2
Timepoint
At the beginning and at the end of study
Method of measurement
ABG assay system

3

Description
D-dimer that is fibrin degradation product (FDP)
Timepoint
At the beginning and at the end of study
Method of measurement
By ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Subcutaneous administration of 250 microgram IFN beta-1-b every other day
Category
Treatment - Drugs

2

Description
Control group: Control group will receive Covid-19 routine prescription.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Dr.Negahi
Street address
بلوار جمهوری اسلامی
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915595
Phone
+98 76 3334 7000
Email
shmh@hums.ac.ir
Web page address
https://shmh.hums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teymour Aghamolaei
Street address
Shafa Ave.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915189
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
research@hums.ac.ir
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Afshin Samiei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology- Faculty of Medicine - Emam Hossein Blvd. -
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0373
Email
afshin.samiei@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Afshin Samiei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Immunology Dept.- Faculty of Medicine - Emam hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919698116
Phone
+98 76 3371 0373
Email
afshin.samiei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Afshin Samiei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Immunology Dept.- Faculty of Medicine - Emam hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919698116
Phone
+98 76 3371 0373
Email
afshin.samiei@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
only outcome information will be presented
When the data will become available and for how long
3 month after publishing the results
To whom data/document is available
everyone
Under which criteria data/document could be used
not restricted
From where data/document is obtainable
afshin.samiei@gmail.com
What processes are involved for a request to access data/document
sending an E-mail
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