The effect of pentaglobin on patients with coronavirus
Design
covid-19patients admitted to the intensive care unit and who had severe respiratory failure and lack of adequate response to treatment were included in the group, and a 7 mg.kg pentaglobin ampoule was gradually infused for 5 days. The general symptoms of patients and CT scans of patients were noted.
Settings and conduct
Patients admitted to the ICU who have respiratory failure and have not responded to treatment. They are selected and infused with pentaglobin ampule patients and patients' symptoms are noted.
Participants/Inclusion and exclusion criteria
Non-intubated patients
Positive covid patients
Patients over 18 years of age
Intervention groups
covid-19patients admitted to the intensive care unit and who had severe respiratory failure
Main outcome variables
improve oxygenation; improve ct scans
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N27
Registration date:2020-06-15, 1399/03/26
Registration timing:registered_while_recruiting
Last update:2020-06-15, 1399/03/26
Update count:0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pentaglobin in the treatment of critically ill patients with COVID-19
Public title
The effect of pentaglobin in the treatment of critically ill patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Covid patients
Patients over 18 years
Non-intubated patients
Exclusion criteria:
Patients with dissatisfaction
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Masih Daneshvari Hospital the Edjucational , Research and Treatment center.
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.014
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
covid19 disease
Primary outcomes
1
Description
Improve oxygenation
Timepoint
0,1,2,3,7after treatment with cyclosporin
Method of measurement
Pulse oximeter
2
Description
Improve ct scan
Timepoint
Seven days after treatment
Method of measurement
CT scan unit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patient under pentaglobin treatment: Patients who have acute respiratory failure due to covid-19 and do not respond to antiretroviral therapy due to the unknown nature of the disease to reduce inflammatory cytokines in patients with slow pentaglobin injections within two hours of infusion and seven days continue and the general condition of patients and symptoms Patient and CT-scans are checked
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Seyyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2265
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Seyyed Mohamadreza Hashemian
Street address
Shahid Beheshti University of Medical Sciences, Tabnak Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
iran.criticalcare@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research and Technology, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
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
Yes - There is a plan to make this available
Title and more details about the data/document
All patient information can be published after deleting the name
When the data will become available and for how long
It will take a month from the time of application
To whom data/document is available
All professors of medical universities in the country
Under which criteria data/document could be used
Help advance science
From where data/document is obtainable
professor hashemian in masih daneshvari hospital
What processes are involved for a request to access data/document