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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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15 June 2020 |
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Main ID: |
IRCT20200501047259N1 |
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Date of registration:
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2020-05-17 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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IVIG and COVID19
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Scientific title:
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Intravenous immunoglubolin (IVIG) effect on improvement of severe pulmonary damage in COVID 19 disease |
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Date of first enrolment:
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2020-05-09 |
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Target sample size:
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40 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/47609 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: computer- generated random number table, 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.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Reza Hajizadeh
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Address:
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kashani street talegani hospital
5714783734
Urmia
Iran (Islamic Republic of) |
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Telephone:
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+98 44 3344 4593 |
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Email:
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hajizadh.reza@gmail.com |
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Affiliation:
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Oroumia University of Medical Sciences |
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Name:
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Naser Gharebaghi
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Address:
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Kashani street
5714783734
Urmia
Iran (Islamic Republic of) |
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Telephone:
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+98 44 3344 4593 |
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Email:
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hajizadh.reza@gmail.com |
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Affiliation:
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Oroumia University of Medical Sciences |
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Key inclusion & exclusion criteria
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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 minimum:
18 years
Age maximum:
100 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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COVID19
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COVID19.
COVID19
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Intervention(s)
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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.
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Primary Outcome(s)
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Increasing of patient's O2 saturation above 90%, improvement of lung involvement in lung CT scan. Timepoint: before discharge. Method of measurement: percentile.
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Source(s) of Monetary Support
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Oroumia University of Medical Sciences
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Ethics review
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Status: Approved
Approval date: 08/04/2020
Contact:
Ethics committee of Urmia University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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