Efficacy of different methods of administeration of combination regiemn including dexamethasone, IV-IG and Interferone beta for treatment of patients with severe COVID-19: a randomized controlled trial
To determine the efficacy of different methods of administeration of combination regiemn including dexamethasone, IV-IG and Interferone beta for treatment of patients with severe COVID-19
Design
This is a phase 2 randomized controlled trial with 3 parallel arms without blinding.
Participants will be recruited in 3 arms including control, intervention 1 and intervention 2 arms. Participants will be allocated in the study arms using a simple randomization method.
Settings and conduct
The study will be conducted in hospitals of Golestan province. Data on demographic and risk factors will be collected using a questionnaire. Clinical data as well as lab data (SpO2,...) and imaging results will be collected from the hospital information system.
Participants/Inclusion and exclusion criteria
Inclusion: age 18-70 years old; severe COVID 19 disease.
Exclusion: need for intubation; contraindication of contortionists, IV IG and interferon beta; pregnancy or lactation.
Intervention groups
Control arm: receive standard treatment for COVID19 according to the protocol of MOH of Iran. Intervention 1: receive standard treatment for COVID19 and combination of dexamethadone, IV-IG and Interferon beta at admission. Intervention 2: receive standard treatment for COVID19 and combination of dexamethasone, IV-IG and Interferon beta 48 hours after admission.
Main outcome variables
Improvement in SpO2 (increasing in level of SpO2 to levels higher than 90%)
General information
Reason for update
Acronym
DIIC19
IRCT registration information
IRCT registration number:IRCT20120225009124N4
Registration date:2020-04-02, 1399/01/14
Registration timing:prospective
Last update:2020-04-02, 1399/01/14
Update count:0
Registration date
2020-04-02, 1399/01/14
Registrant information
Name
Gholamreza Roshandel
Name of organization / entity
Golestan University of Medical Sciences/ Golestan Research Center of Gastroenterology and Hepatology
Country
Iran (Islamic Republic of)
Phone
+98 17 3225 1910
Email address
roshandel@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of different methods of administeration of combination regiemn including dexamethasone, IV-IG and Interferone beta for treatment of patients with severe COVID-19: a randomized controlled trial
Public title
Efficacy of dexamethasone, IV-IG and Interferone beta for treatment of patients with severe COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-70 years
Sever COVID19 disease with the following criteria: SPpO2 below 90% and respiratory rate higher 24 per minute; Involvement of more that 50% of lung in CT-scan
Exclusion criteria:
Need for intubation at the time of admission
Contraindication of corticosteroids, IV IG and interferon beta
Pregnancy, lactation
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into study groups using a simple randomization method. The allocation process will be concealed to the physician and researchers. Allocation concealment will be made using sealed envelope system.
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 Golestan University of Medical Sciences
Street address
Sahst-kola, Falsafi campus
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-04-02, 1399/01/14
Ethics committee reference number
IR.GOUMS.REC.1399.004
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
Improvement in SpO2 (increasing in level of SpO2 to levels higher than 90%)
Timepoint
After finishing the intervetion
Method of measurement
By Pulse oximeter
Secondary outcomes
1
Description
Duration of stay in hospital
Timepoint
After finishing the intervention
Method of measurement
Reviewing patient hospital file
2
Description
Intubation
Timepoint
After finishing the intervention
Method of measurement
Reviewing patient hospital file
3
Description
Mortality
Timepoint
After finishing the intervention
Method of measurement
Reviewing patient hospital file
Intervention groups
1
Description
Control group: Receive standard treatment for COVID19 according to the protocol of MOH of Iran (antiviral drugs and hydroxychloroquine)
Category
Treatment - Drugs
2
Description
Intervention group 1: Receive standard treatment for COVID19 and combination of dexamethadone, IV-IG and Interferon beta at admission
Category
Treatment - Drugs
3
Description
Intervention group 2: Receive standard treatment for COVID19 and combination of dexamethasone, IV-IG and Interferon beta 48 hours after admission
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayyad Shirazi hospital
Full name of responsible person
Dr Nafiseh Abdolahi
Street address
Sayyad Shirazi Boulevard
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1910
Email
grcgh@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammadreza Honarvar
Street address
Sast-Kola, Falsafi campus
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Dr Nafiseh Abdolahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sayyad Shirazi boulevard, Sayyad Shirazi hospital
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1910
Email
n_abdolahi2002@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Gholamreza Roshandel
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Golestan Research Center of Gastroenterology and Hepatology, Sayyad Shirazi hospital
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1910
Fax
Email
roshandel@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Gholamreza Roshandel
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Golestan Research Center of Gastroenterology and Hepatology, Sayyad Shirazi hospital
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1910
Fax
Email
roshandel@goums.ac.ir
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Anonymized individual data
When the data will become available and for how long
After publication of the paper
To whom data/document is available
All interested researchers
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
Deputy of research of Golestan University of Medical Sciences
What processes are involved for a request to access data/document
By submission an approved research proposal to deputy of research of Golestan University of Medical Sciences