Intravenous immunoglubolin (IVIG) effect on improvement of severe pulmonary damage in COVID 19 disease according to improvement in o2 saturation, mortality, hospital and ICU stay, improvement of fever and lung involvement in lung CT scan
Design
In this pilot study 40 patients with definite COVID 19 with poor response to first line drugs including at least one antiviral and chloroquine drugs, which have O2 saturation less than 90% and more than 30 percent involvement in lung CT scan randomly will assign into two groups, first group will receive intravenous immunoglobulin with a dose of 20 gram per day for at least 3 days, control group will take placebo, patients will be evaluated for improvement in o2 saturation (increasing above 90%) hospital death, improvement of fever, and ICU stay. Randomization will be performed by means of a computer-generated randomization schedule, and only the pharmacist of center will have knowledge about drug or placebo and , neither the patients nor the physicians nor whom responsible for data analysis will be aware of the types of treatment allocated. We will use 5 gr IVIG vials, so 4 vials will be used for each patient every 24 hours for at least 3 days. control group will receive placebo.
Settings and conduct
Ayatollah Talegani hospital
Participants/Inclusion and exclusion criteria
more tahn 30% involvement of lungs, age>18, no response to first line drugs
Intervention groups
definite COVID 19
Main outcome variables
improvement in o2 saturation , dyspnea, shortening of hospital stay and decreased mortality
General information
Reason for update
Acronym
IVIG(intravenous immunoglobulin)
IRCT registration information
IRCT registration number:IRCT20200501047259N1
Registration date:2020-05-17, 1399/02/28
Registration timing:registered_while_recruiting
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Naser Gharebaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3344 4593
Email address
gharabaghi.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravenous immunoglubolin (IVIG) effect on improvement of severe pulmonary damage in COVID 19 disease
Public title
IVIG and COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
stablished COVID 19 in PCR test
age more than 18
no response to at least one antiviral and chloroquine drugs
more than 30% involvement in chest computed tomography
Exclusion criteria:
pregnant women
coagulopathies
previous hypersensitivity to IVIG
left ventricular ejection fraction less than 35%
previous lung fibrosis or lung surgery
LUNG SARCOIDOSIS OR TUBERCULOSIS
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
computer- generated random number table
Blinding (investigator's opinion)
Triple blinded
Blinding description
randomization of patients will be done by computer- generated random number table and the pharmacist of center only will have knowledge of the randomization code. neither the patients nor the physicians nor those responsible for data analysis were aware of the types of treatment allocated. vials of IVIG and placebo will be in the same shape only code on them different
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Kashani street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.UMSU.REC.1399.025
Health conditions studied
1
Description of health condition studied
COVID19
ICD-10 code
COVID19
ICD-10 code description
COVID19
Primary outcomes
1
Description
increasing of patient's O2 saturation above 90%, improvement of lung involvement in lung CT scan
Timepoint
before discharge
Method of measurement
percentile
Secondary outcomes
empty
Intervention groups
1
Description
Immune Globulin intravenous (human) flebogamma 5% DIF GRIFOLS will be used, each vial has 5 gram IVIG and patient will receive 4 vial every day for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Talegani hospital
Full name of responsible person
Naser Gharebaghi
Street address
kashani street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3344 4593
Email
hajizadh.reza@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Gharebaghi
Street address
Kashani street
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3344 4593
Email
hajizadh.reza@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Naser Gharebaghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Kashani street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3344 4593
Email
hajizadh.reza@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Hajizadeh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
kashani street talegani hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3344 4593
Email
hajizadh.reza@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Hajizadeh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
kashani street talegani hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3344 2200
Email
hajizadh.reza@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
SPSS file
When the data will become available and for how long
6 months after publication
To whom data/document is available
researchers of valid institutes
Under which criteria data/document could be used
for furthur evaluation and meta analysis
From where data/document is obtainable
Urmia University of medical sciences
What processes are involved for a request to access data/document
Requests should be sent by email to Urmia University of Medical Sciences