The effectiveness of Intravenous immunoglobulin (IVIG) for the treatment of Coronavirus induced cytokine storm will be studied.
Design
A clinical trial with a control group, with parallel groups, simple-randomly assigned to intervention and control groups, Phase 3, 100 patient
Settings and conduct
This study will be performed in Imam Reza Hospital, Tabriz, Iran. 100 patients will be divided into two groups (50 in each group) by simple randomization. Patients in the control group will be prescribed a standard regimen for COVID-19. The intervention group will be prescribed by intravenous immunoglobulin 100-200 mg oral two times daily for two days and a standard regimen for COVID-19. CT scan of lungs, biochemical tests, hospitalization period, need to intubation and mortality rate will be assessed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with moderate to severe cytokine storm and respiratory symptoms (ARDS); Patients with a respiratory rate of more than 30; PaO2/FiO2 less than 300 mm Hg; Age 18-65 year. Exclusion criteria: sensitivity to IVIG, IgA deficiency syndrome; pregnant or lactating women; severe respiratory failure؛ immediate need for intubation
Intervention groups
Intervention group: will receive a standard regimen for COVID-19 plus intravenous immunoglobulin (IVIG). Control group: will receive a standard regimen for COVID-19.
Main outcome variables
The change of pneumonia severity on CT scanning; decrease hospitalization period; decrease ARDS symptoms; decrease mortality; decrease hospitalization period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200317046797N3
Registration date:2020-04-11, 1399/01/23
Registration timing:prospective
Last update:2020-04-11, 1399/01/23
Update count:0
Registration date
2020-04-11, 1399/01/23
Registrant information
Name
Sepideh Zununi Vahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
sepide.zununi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effectiveness of intravenous immunoglobulin (IVIG) for the treatment of COVID-19-induced cytokine storm
Public title
Intravenous immunoglobulin (IVIG) in the treatment of COVID-19-induced cytokine storm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Respiratory rate more than 30
PaO2/FiO2 less than 300 mm Hg
Positive PCR for COVID -19
Age 18-65 year
Exclusion criteria:
Sensitivity to IVIG
Pregnancy
IgA deficiency syndrome
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be generated with a computer from 1 to 100. The computer will divide the digits between the two groups. According to the sequences of admission, they will go to the control or the IVIG group regarding the computerized random list.
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.TBZMED.REC.1399.003
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
U07.1: COVID-19, virus identified
2
Description of health condition studied
Coronavirus (COVID-19)-induced pneumonia
ICD-10 code
J12.81
ICD-10 code description
Pneumonia due to SARS-associated coronavirus
Primary outcomes
1
Description
Improving the general condition of the patient
Timepoint
Before and after intervention
Method of measurement
Lung CT scan; No need to receive any intensive respiratory care in the patient
2
Description
Mortality rate
Timepoint
At baseline and discharge time or patient death
Method of measurement
Observation
3
Description
Need for intubation
Timepoint
Period of hospitalization
Method of measurement
Observation or reading of hospitalized documents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 patients with Coronavirus (COVID-19)-induced moderate or severe pneumonia in addition to the standard regimen of covid-19، will receive IVIG for 2 days (100-200 mg two-wise a day). Privigen, Behring company, Switzerland
Category
Treatment - Drugs
2
Description
Control group: will receive a standard regimen of covid-19 based on national protocol including Hydroxychloroquine, Ribavirin and Kaletra).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Immamreza Hospita of Tabriz
Full name of responsible person
Dr Khalil Ansarin
Street address
Imamreza Hospital, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
3th floor of Tabriz University of Medical Sciences Central Building, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
ardalan34@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
ardalan34@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sepideh Zununi Vahed
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
sepide.zununi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available