Protocol summary

Study aim
Evaluation of Convalescent Plasma Therapy for COVID-19 Patients
Design
This study is a randomized clinical trial (RCT) of the prospective applied research type. Two groups of 20 patients with severe disease are included in the study as intervention and control groups. People under the age of 60 will be selected from patients with severe illness. In all respects, the control group includes age, sex, and drug use.
Settings and conduct
200 ml of plasma prepared from the blood bank of improved individuals with the same blood type as the target group is injected intravenously twice into patients in the intervention group who are hospitalized. Patients in the control group are not injected with blood plasma and receive the usual treatment protocol. In the days after treatment, clinical and laboratory symptoms, and the recovery process are compared between the intervention and control groups. Blinding is not predicted in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with severe corona disease and age less than 60 years. Exclusion criteria: having a history of immune and/or other infectious diseases.
Intervention groups
The intervention group is injected with the same blood group twice and 200 ml each time. The control group does not receive plasma. The control group in all respects includes age, sex, drug use, and the group being matched.
Main outcome variables
The patient's age, Clinical protests, Mortality rate, Serological and molecular tests, Duration of hospitalization

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200503047281N1
Registration date: 2020-07-25, 1399/05/04
Registration timing: prospective

Last update: 2020-07-25, 1399/05/04
Update count: 0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Farzaneh Fesahat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3628 5406
Email address
farzaneh.fesahat@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Convalescent Plasma Therapy for COVID-19 Patients
Public title
Evaluation of Convalescent Plasma Therapy for COVID-19 Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20 to 60 years old
Exclusion criteria:
People with a history of other immune, genetic or infectious diseases other than corona Individual suspended but negative for clinical standard covid-19 test
Age
From 20 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using a table of random numbers. In this method, all patients who meet the inclusion criteria are assigned a number from the file number and these numbers are randomly placed in the table of numbers. Then 20 numbers without the possibility of replacement as an intervention group and 20 people as the control group will be selected.
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 Shahid Sadoughi University of MEdical Sciences
Street address
Daneshjoo Blv. reproductive immuology research center, Shadid Sadoughi University ,Yazd,Iran
City
yazd
Province
Yazd
Postal code
8916188635
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.SSU.REC.1399.001

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
Percentage of patients discharged from the intensive care unit and hospital
Timepoint
Measurement of all standard clinical signs of the disease before the start of plasma therapy and after the start of each injection of plasma over specific intervals of up to one year (if surviving)
Method of measurement
Patient file information

Secondary outcomes

1

Description
Patient mortality rate
Timepoint
Recording the mortality rate for one year after starting plasma therapy
Method of measurement
Patient file information

Intervention groups

1

Description
Intervention group: 20 patients are in the severe stage of the disease who receive plasma therapy with intravenous injection dose twice (200 ml per dose) and in addition to routine medical care.
Category
Treatment - Drugs

2

Description
Control group: 20 patients admitted to the severe stage of the disease who did not receive plasma therapy and receive only routine medical care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Shahid sadoughi hospital
Full name of responsible person
Dr. Hossein Hadinedoushan
Street address
Shahid Sadoughi Hospital, Ibn Sina St., Shahid Ghandi Blvd., Safaieh,Yazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
medschool@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Headquarters of Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3146 2136
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hossein Hadinedoushan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Reproductive Immunology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916188635
Phone
+98 35 3628 5406
Email
hhadin2000@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Hossein Hadinedoushan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
School of Paramedical Sciences, Imam Reza Educational and Research Complex, Daneshjoo Blvd., Imam Hossein Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916188635
Phone
+98 35 3628 5406
Email
hhadin2000@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Fesahat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Reproductive Immunology Research Center, Shahid Sadoughi University of Medical Sciences,Daneshjoo Blvd. Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8916188635
Phone
+98 35 3628 5406
Email
farzaneh.fesahat@gmail.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
Undecided - It is not yet known if there will be 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 data can be published after coding and unidentifiable and privacy.
When the data will become available and for how long
after article publication
To whom data/document is available
All researchers specialize in related fields
Under which criteria data/document could be used
In order to use the results by the scientific community of the world, the information can be published after printing and by observing the coding and confidentiality of the participants in the study upon request.
From where data/document is obtainable
To the first author or the corresponding person of the published article through their email Dr. Hossein Hadi Nodoshan.hhadin2000@gmail.com
What processes are involved for a request to access data/document
The request and how to use the data must be explained by e-mail to the author responsible for the article, which will be received as soon as possible.
Comments
Loading...