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Evaluation of the effectiveness of intravenous infusion of human COVID-19 hyperimmune plasma with specific antibody titer in hospitalized patients with Covid-19: a randomized clinical trial

Protocol summary

Study aim
Evaluation of the effectiveness of intravenous infusion of human COVID-19 hyperimmune plasma with specific antibody titer in hospitalized patients with Covid-19: a randomized clinical trial
Design
Case-control, 3 arm, parallel, single center, phase 3 clinical trial
Settings and conduct
This study will be performed in the lung diseases ward of Imam Khomeini Hospital in Tehran. Eligible patients with free and informed written consent will randomly assigned to one of the study groups and receive the relevant intervention.
Participants/Inclusion and exclusion criteria
Confirmed or suspected COVID-19 pneumonia based on PCR or pulmonary imaging; Presenting clinical symptoms of COVID-19 (fever, cough, dyspnea); O2 saturation equal or less than 93%; Age equal or more than 18 years old; The patient has informed and free written consent to participate in the study; Less than 7 days passed from the onset of clinical symptoms to the time of enrollment; The patient should not attend another clinical trial at the same time.
Intervention groups
Arm1: Human COVID-19 hyperimmune plasma with a specific antibody titer, volume 500ml, intravenous infusion over 4 hours; In addition to routine treatment based on the latest update of the national protocol. Arm2: Routine Human COVID-19 hyperimmune plasma, volume 500ml, intravenous infusion over 4 hours; In addition to routine treatment based on the latest update of the national protocol. Arm3: Routine treatment based on the latest update of the national protocol.
Main outcome variables
Requirement of receiving ICU care, mortality rate, requirement of mechanical ventilation, length of hospitalization, NEWS2 score changes, Ordinal Scale changes, chest ct-scan score changes, side effects.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201004048922N1
Registration date: 2020-10-10, 1399/07/19
Registration timing: prospective

Last update: 2020-10-10, 1399/07/19
Update count: 0
Registration date
2020-10-10, 1399/07/19
Registrant information
Name
Hamidreza Abtahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2796
Email address
hrabtahi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of intravenous infusion of human COVID-19 hyperimmune plasma with specific antibody titer in hospitalized patients with Covid-19: a randomized clinical trial
Public title
Evaluation of the effectiveness of intravenous infusion of human COVID-19 hyperimmune plasma with specific antibody titer in hospitalized patients with Covid-19: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed or suspected COVID-19 pneumonia based on PCR or pulmonary imaging; Presenting clinical symptoms of COVID-19 (fever, cough, dyspnea); O2 saturation equal or less than 93%; Age equal or more than 18 years old; The patient has informed and free written consent to participate in the study; Less than 7 days passed from the onset of clinical symptoms to the time of enrollment; The patient should not attend another clinical trial at the same time.
Exclusion criteria:
Advanced renal or liver disease; Active cancer; Known Hypersensitivity reaction to Plasma-derived drugs; Pregnancy; Lactation; The patient may be excluded from the study during the first 48 hours.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Block Randomization method will be used. To perform, by visiting the site www.sealedenvelope.com, while entering the number of intervention groups, sample size, block size (which was selected according to the number of study groups, 6), a random list of patients in 3 groups will be obtained that this list will be used for random allocation of patients.
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 Tehran University of Medical Sciences
Street address
Building No. 1 of the School of Medicine, Poursina St. North Door of the University, Ghods St., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.436

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19

Primary outcomes

1

Description
Length of hospital stay due to covid-19
Timepoint
Daily until discharge or death
Method of measurement
Count the days of hospitalization from the time of admission to the hospital until discharge or death

Secondary outcomes

1

Description
Mortality rate on day 28
Timepoint
Day 28 from enrollment
Method of measurement
Clinical assessment

2

Description
Requirement rate of mechanical ventilation
Timepoint
day 1 to 7
Method of measurement
Clinical assessment

3

Description
Requirement rate of receiving ICU care
Timepoint
Day 1 to 7
Method of measurement
Clinical assessment

4

Description
The 7-point ordinal scale
Timepoint
Day 1 and 7
Method of measurement
Clinical assessment

5

Description
National Early Warning Score 2 (NEWS2) changes
Timepoint
Day 1 and 7
Method of measurement
Clinical assessment and laboratory findings

6

Description
Chest CT-scan score changes
Timepoint
Day 1 and 28
Method of measurement
Chest CT scan

7

Description
Side effects
Timepoint
Day 1 to 7
Method of measurement
Clinical assessment

Intervention groups

1

Description
Intervention group: Human COVID-19 hyperimmune plasma with a specific antibody titer, volume 500ml, intravenous infusion over 4 hours; In addition to routine treatment based on the latest update of the national protocol.
Category
Treatment - Drugs

2

Description
Intervention group: Routine Human COVID-19 hyperimmune plasma, volume 500ml, intravenous infusion over 4 hours; In addition to routine treatment based on the latest update of the national protocol.
Category
Treatment - Drugs

3

Description
Control group: Routine treatment based on the latest update of the national protocol.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini Complex hospital
Full name of responsible person
Mohammadreza Salehi
Street address
Dr.Gharib St, End of Keshavrz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6693 9001
Email
salehi.mohamad3@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraeiyan
Street address
6th floor, University Central Organization, corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hamidreza Abtahi
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonary disease
Street address
Imam Khoemini Complex hospital, Dr.Gharib St., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9001
Email
hrabtahi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamidreza Abtahi
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonary disease
Street address
Imam Khomeini Complex hospital, Dr.Gharib St., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9001
Email
hrabtahi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Kianpour
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherpay
Street address
Pharmacy faculty, Tehran University of Medical Science, 16 Azar St., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Email
Parisa_kianpour@yahoo.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
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