Protocol summary

Study aim
Determination of the effects of COVID-19 convalescent plasma in acute respiratory distress syndrome due to COVID-19
Design
Present study is randomized, parallel, clinical trial.
Settings and conduct
the present study will be done in hospitalized COVID-19 patients at Urmia University of Medical Sciences hospitals. patients divided into 3 groups that will receive standard treatment and 2 of them will receive different doses of convalescent plasma.
Participants/Inclusion and exclusion criteria
1-Positive PCR test 2-dyspnea 3-respiratory frequency ≥ 30/min 4-blood oxygen saturation ≤ 93% 5-the partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 6-lung infiltrates > 50% within 24 to 48 hours 7- The life-threatening disease is defined as respiratory failure
Intervention groups
1-control group: standard treatment 2-first interventional group: 2-5 cc/kg convalescent plasma (days 1,3,5) 3-second interventional group: 8-10 cc/kg convalescent plasma (day 1)
Main outcome variables
hospitalization time, ICU admission time, mechanical ventilation time, survival rate.

General information

Reason for update
Acronym
COVID-19
IRCT registration information
IRCT registration number: IRCT20200501047258N1
Registration date: 2020-05-04, 1399/02/15
Registration timing: registered_while_recruiting

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Rahim Asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 7286
Email address
asghari.r@umsu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of COVID-19 convalescent plasma in acute respiratory distress syndrome due to COVID-19
Public title
effects of convalescent plasma in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR test The life-threatening disease is defined as respiratory failure dyspnea respiratory frequency ≥ 30/min blood oxygen saturation ≤ 93% partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 lung infiltrates > 50% within 24 to 48 hours
Exclusion criteria:
Pregnancy Hypersensitivity to blood or blood products Uncontrolled bacterial infection Disagreement
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
More than 1 sample in each individual
Number of samples in each individual: 5
CD4, CD8 Lymphocytes/ IL-6, TNF/ Plt/ Hb/ WBC/ Lymphocytes/ Neutrophils/ BUN/ Cr/ AST/ ALT/ ALP/ Bill (T,D)/ Vitamin D/ D-dimer
Randomization (investigator's opinion)
Randomized
Randomization description
We use block randomization and according to the study design patients will be divided into two groups (severe and critical). firstly, we will create two separate blocks size equal to 6 (AABBCC). Secondly, we will list all permutation of them and assigned code for each permutation. We will select 10 blocks using a simple random method for two study groups (severe and critical).
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
Urmia University of Medical Sciences
Street address
Resalat Street, UMSU.
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Approval date
2020-04-26, 1399/02/07
Ethics committee reference number
IR.UMSU.REC.1399.030

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
Hospitalization time
Timepoint
0, 1, 3, 7, 14 days
Method of measurement
check list

2

Description
ICU admission time
Timepoint
0, 1, 3, 7, 14 days
Method of measurement
check list

3

Description
mechanical ventilation time
Timepoint
0, 1, 3, 7, 14 days
Method of measurement
check list

4

Description
survival rate
Timepoint
0, 1, 3, 7, 14 days
Method of measurement
check list

Secondary outcomes

1

Description
CT scan
Timepoint
0- 1- 3- 7- 14 days
Method of measurement
CT scan

2

Description
serological tests
Timepoint
0- 1- 3- 7- 14 days
Method of measurement
ELISA

3

Description
hematological markers
Timepoint
0- 1- 3- 7- 14 days
Method of measurement
flowcytometry

4

Description
clinical findings
Timepoint
0- 1- 3- 7- 14 days
Method of measurement
check list

Intervention groups

1

Description
Intervention group 1: hospitalized patients received convalescent plasma with 2-5 cc/kg transfused on 1, 3, 5 days after treatment that treated with the standard national guideline.
Category
Treatment - Drugs

2

Description
Intervention group 2: hospitalized patients received convalescent plasma with 8-10 cc/kg transfused on 1 day after treatment that treated with the standard national guideline.
Category
Treatment - Drugs

3

Description
Control group: hospitalized patients treated with the standard national guideline.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
hospitals of UMSU
Full name of responsible person
Rahim Asgari
Street address
Resalat street, UMSU
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Phone
+98 44 3223 4897
Fax
+98 44 3222 9059
Email
rahimasghari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Resalat street, UMSU
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Phone
+98 44 3223 4897
Fax
+98 44 3222 9059
Email
rahimasghari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia University of Medical University
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
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Asghari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology & medical oncology
Street address
Resalat street, UMSU
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Phone
+98 44 3223 4897
Email
rahimasghari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Asghari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
hematology & medical oncology
Street address
Resalat st, UMSU
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Phone
+98 44 3223 4897
Email
rahimasghari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Asghari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
hematology & medical oncology
Street address
Resalat st, UMSU
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Phone
+98 44 3223 4897
Email
rahimasghari@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
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
Not applicable
Title and more details about the data/document
Aggregate data can be shared.
When the data will become available and for how long
A year after beginning of study.
To whom data/document is available
this study only available for people working in academic institutions.
Under which criteria data/document could be used
take permission from UMSU and research team members.
From where data/document is obtainable
Resalat st, UMSU
What processes are involved for a request to access data/document
Contact with UMSU
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