Protocol summary

Study aim
Evaluation of the therapeutic effects of Convalescent Plasma (CP) of recovered people from Covid-19 in improving clinical and laboratory symptoms of hospitalized patients
Design
The clinical trial with a control group, with parallel groups, non-randomized, single-center. The sample size is 12 patients (consist of 2 groups of 6 control and intervention).
Settings and conduct
This study will be performed at Kosar hospital in Semnan. Convalescent plasma from COVID-19 recovered people will be injected to hospitalized patients suffering from COVID-19.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Complete resolution of COVID-19 disease symptoms at least 14 days prior to donation; Donors do not have a history of blood or blood product transfusion; COVID-19 neutralizing antibody titers be greater than 1:320 (If possibly checked); Negative results for COVID-19 by PCR; Respiratory frequency ≥ 30/min. Exclusion criteria: Negative real-time PCR from respiratory secretions or blood within 48 h prior to CP transfusion; History of allergic reaction to blood or plasma products; Known IgA deficiency.
Intervention groups
Intervention group: Administration of 2 units of intravenous CP (Convalescent Plasma obtained from COVID-19 recovered people thorough plasmapheresis). Each unit of plasma that is collected from one different donor will be given over 2 h with an interval of 1 h between the two units. Control group: Patients with COVID-19 will receive conventional treatment.
Main outcome variables
Checking the amount of ventilation; White blood cell count, CRP in patients with COVID-19; Percentage of T CD8 in peripheral blood; Percentage of T CD4 in peripheral blood; C-Reactive Protein (CRP) in patients with COVID-19

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025732N53
Registration date: 2020-04-10, 1399/01/22
Registration timing: prospective

Last update: 2020-04-10, 1399/01/22
Update count: 0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effects of Convalescent Plasma (CP) of recovered people from Covid-19 in improving clinical and laboratory symptoms of hospitalized patients
Public title
Therapeutic effects of plasma of recovered people from COVID-19 on hospitalized patients with this disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
(As a plasma donor): Complete resolution of COVID-19 disease symptoms at least 14 days prior to donation. (As a plasma donor): Donors do not have a history of blood or blood product transfusion (As a plasma donor): COVID-19 neutralizing antibody titers be greater than 1:320 (If possibly checked) (As a plasma donor): The donor's age be between 25 and 55 years old (As a plasma donor): Negative results for COVID-19 by PCR (As a plasma donor): Be in suitable general health condition for plasmapheresis (As a plasma recipient): Patients admitted to the ICU who is receipt of mechanical invasive or non-invasive ventilation, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300mmHg (93%). Current receipt of intravenous vasoactive medications to maintain mean arterial pressure >65 mmHg (As a plasma recipient): Respiratory frequency ≥ 30/min (As a plasma recipient): Laboratory-confirmed COVID-19 infection (by real time PCR).
Exclusion criteria:
(As a plasma recipient): Negative real-time PCR from respiratory secretions or blood within 48 h prior to CP transfusion (As a plasma recipient): History of allergic reaction to blood or plasma products (As a plasma recipient): Known IgA deficiency
Age
From 25 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 12
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-04-04, 1399/01/16
Ethics committee reference number
IR.SEMUMS.REC.1399.004

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Checking the amount of ventilation
Timepoint
Before intervention, 30 minutes after each step of intervention and daily
Method of measurement
Artificial respirator or ventilator

2

Description
White blood cell count, CRP in patients with COVID-19
Timepoint
Every 24 hours (Before and after intervention)
Method of measurement
Cell counter

3

Description
Percentage of T CD8 in peripheral blood
Timepoint
Before and after the intervention
Method of measurement
Evaluation of T CD8 percentage by Flow cytometry

4

Description
Percentage of T CD4 in peripheral blood
Timepoint
Before and after the intervention
Method of measurement
Evaluation of T CD4 percentage by Flow cytometry

5

Description
C-Reactive Protein (CRP) in patients with COVID-19
Timepoint
Every 24 hours (Before and after intervention)
Method of measurement
Rapid test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Administration of 2 units of CP (Convalescent Plasma obtained from COVID-19 recovered people thorough plasmapheresis) (IV). Each unit of plasma that is collected from one different donor will be given over 2 h with an interval of 1 h between the two units.
Category
Treatment - Drugs

2

Description
Control group: Patients with COVID-19 will receive conventional treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Koesar hospital
Full name of responsible person
Parviz Kokhaei
Street address
Amin street, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
are20935@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Semnan University of Medical Sciences, Basij boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Semnan University of Medical Sciences, Basij boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maral Hemati
Position
Academic Research Expert
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Semnan University of Medical Sciences, Basij boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
m.scientist1993@gmail.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
No - There is not a plan to make this available
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