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Protocol summary
The rate of reduction in the duration of hospital stay of patients; mortality reduction; requirement of artificial ventilation and entry into the ICU; The rate of achieve to 3 point decrease in WHO clinical scale since plasma usage OR WHO score less than 3 (each achieved first)
The rate of reduction in the duration of hospital stay of patients; mortality reduction; requirement of artificial ventilation and entry into the ICU; The rate of achieve to minimum 2 point decrease in WHO clinical scale since plasma usage OR WHO score less than 3 (each achieved first)
The rate of reduction in the duration of hospital stay of patients; mortality reduction; requirement of artificial ventilation and entry into the ICU; The rate of achieve to 3minimum 2 point decrease in WHO clinical scale since plasma usage OR WHO score less than 3 (each achieved first)
طول مدت بستری بیماران، مورتالیتی بیماران بستری شده، نیاز به تهویه مصنوعی و ورود به آی سی یو , ریت رسیدن به نمره بالینی حداقل 3نمره کمتر از زمان تزریق پلاسما یا نمره بالینی کمتر از 3 (هرکدام زودتر)
طول مدت بستری بیماران، مورتالیتی بیماران بستری شده، نیاز به تهویه مصنوعی و ورود به آی سی یو , ریت رسیدن به نمره بالینی حداقل 2 نمره کمتر از زمان تزریق پلاسما یا نمره بالینی کمتر از 3 (هرکدام زودتر)
طول مدت بستری بیماران، مورتالیتی بیماران بستری شده، نیاز به تهویه مصنوعی و ورود به آی سی یو , ریت رسیدن به نمره بالینی حداقل 3نمره2 نمره کمتر از زمان تزریق پلاسما یا نمره بالینی کمتر از 3 (هرکدام زودتر)
Primary outcomes
#1
Reduce 3 points on clinical signs or score less than 3 each earlier.
Reduce at least 2 points on clinical signs or score less than 3, each earlier.
Reduce 3at least 2 points on clinical signs or score less than 3, each earlier.
کاهش 3 نمره در علائم بالینی یا نمره کمتر از 3 هر کدام زودتر باشد.
کاهش حداقل 2 نمره در علائم بالینی یا نمره کمتر از 3, هر کدام زودتر باشد.
کاهش 3حداقل 2 نمره در علائم بالینی یا نمره کمتر از 3, هر کدام زودتر باشد.
Protocol summary
Study aim
The purpose of this study is immediate uses of convalescent covid-19 plasma in the treatment of new infected patients at the first day of hospitalization in a clinical trail and evaluate the effectiveness of this type of treatment.
Design
Clinical trials have a control group, with parallel groups and phase 3 on 100 patients.
The case group are 50 patients. The control group are 50 patients who are either not in randomization or not satisfied with receiving plasma.
Settings and conduct
The study is being conducted in Khuzestan province: Ahvaz, Razi Hospital and in Sistan and Baluchestan province: Zahedan, Bouali Hospital.
After being hospitalized by the treating physician in hospital, treatment begins with the diagnosis and judgment of Covid-19. In the case group, plasma injection will be one of the first hospital treatment orders.
Participants/Inclusion and exclusion criteria
Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale will enter the study.
COVID-19 patients who have Score<4 in terms of WHO Progression Scale and more than 24 hours passed from the hospitalization, wont enter the study.
Intervention groups
Convalescent plasma injection, a 500 cc unit will be injected to the case group within 4 hours in addition to antiviral and treatments available at the hospital.
The control group treatment will only be antiviral and inpatient care.
Main outcome variables
The rate of reduction in the duration of hospital stay of patients; mortality reduction; requirement of artificial ventilation and entry into the ICU; The rate of achieve to minimum 2 point decrease in WHO clinical scale since plasma usage OR WHO score less than 3 (each achieved first)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200525047562N1
Registration date:2020-06-14, 1399/03/25
Registration timing:registered_while_recruiting
Last update:2020-06-24, 1399/04/04
Update count:1
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Peyman Eshghi
Name of organization / entity
High institute for research & education in transfusion medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 1582
Email address
p.eshghi@ibto.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-25, 1399/03/05
Expected recruitment end date
2020-07-26, 1399/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immediate uses of convalescent covid-19 plasma in the treatment of new infected patients at the first day of hospitalization in a clinical trail
Public title
Treatment of Covid-19 patients with convalescent plasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale.
The least reasons of hospitalization are dyspnea and/or SPO2<93% or RR>30
The intervention should be performed within the first 24 hours of hospitalization.
Exclusion criteria:
COVID-19 patients having Score<4 in terms of WHO Progression Scale.
More than 24 hours passed from hospitalization.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
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 the High Educational and Research Institute of Transfusion Medicine
Street address
High Educational and Research Institute of Transfusion Medicine, Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449613111
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
IR.TMI.REC.1399.003
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduce at least 2 points on clinical signs or score less than 3, each earlier.
Timepoint
At the beginning of the study (before the start of the intervention) and day 4 of hospitalization, day 7 of hospitalization and discharge time.
Method of measurement
WHO Progression Scale
2
Description
length of hospital stay
Timepoint
Hospitalization time to discharge
Method of measurement
Counting days
Secondary outcomes
1
Description
The rate of need for artificial ventilation and entry into the ICU
Timepoint
From hospitalization to discharge
Method of measurement
Percentage calculation
Intervention groups
1
Description
Intervention group: Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale. Before 24 hours passed from the hospitalization. A 500 cc unit with blood group compatibility between receiver and donor is injected within 4 hours. In patients with grade 7 and above, a plasma unit can be re-injected after 24 hours. Plasma is obtained by apheresis from patients who have recovered from the covid-19 virus in blood transfusion centers.
Category
Treatment - Drugs
2
Description
Control group: The control group is a patient who is hospitalized with suspicion of Covid-19 but either not in randomization or not satisfied with receiving plasma.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Hamid Reza Kouhpayeh
Street address
Bu Ali hospital, Shariati St
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813617697
Phone
+98 54 3322 8102
Email
hkouhpayeh@yahoo.com
2
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Mandana Pouladzadeh
Street address
Razi hospital,In front of the governorate, Palestine Street, Amaniyeh,
City
Ahwaz
Province
Khouzestan
Postal code
6133633366
Phone
+98 61 3333 5937
Email
Mandanapouladzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
High Educational and Research Institute of Transfusion Medicine
Full name of responsible person
Mahtab Maghsoodlu
Street address
High Educational and Research Institute of Blood Transfusion Medicine, Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449613111
Phone
+98 21 8860 1564
Email
maghsoodlu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
High Educational and Research Institute of Transfusion Medicine
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
Iran Blood Transfusion Organization
Full name of responsible person
Saeed Mohammadi
Position
Technical Deputy and New Technologies
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Iran Blood Transfusion Organization, Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449613111
Phone
+98 21 8862 3682
Email
smohammadi@cina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Blood Transfusion Organization
Full name of responsible person
Peyman Eshghi
Position
Chief executive officer of the Blood Transfusion Organization of Iran
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Iran Blood Transfusion Organization, Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449613111
Phone
+98 21 8860 1582
Email
P.eshghi@ibto.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran Blood Transfusion Organization
Full name of responsible person
Shamsi Okati
Position
Specialist physician
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Iran Blood Transfusion Organization, Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
14665-1157
Phone
+98 21 8862 3682
Email
shamsi.okati@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main and secondary consequences can be shared.
When the data will become available and for how long
The access period will start 6 months after the results are printed.
To whom data/document is available
Researchers working at academic and scientific institutes, as well as craftsmen, can apply to receive them.
Under which criteria data/document could be used
The data/document can be used if the reasons of the request are determined .
The type of analysis that will be performed on the delivered data are specified.
Any type of data exploitation must be approved by the project supervisor.
From where data/document is obtainable
He or she can refere to the High Educational and Research Institute of Blood Transfusion Medicine.
Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
Phone:0098 21 88601564
Website: ibto.ir
What processes are involved for a request to access data/document
The High Educational and Research Institute of Blood Transfusion Medicine will receive and review the request, coordinate with the project manager, provide data files and inform to the applicant.