Determining the effect of plasma administration of COVID-19 survivors on one-month mortality of patients with acute respiratory distress syndrome during COVID-19 disease
Design
All eligible patients with ARDS due to COVID-19 admitted to the intensive care unit are randomly divided into two parallel groups. In the control arm, the necessary care will be prescribed according to the current symptoms and standard treatments, and in the intervention arm, the patients will receive the survivors plasma in addition to the treatments of the control group. According to the study conditions, blinding is not done.
Settings and conduct
Imam Reza Hospital, Mashhad
Participants/Inclusion and exclusion criteria
Entry requirements:
1- Po2 / FIO2 ratio less than 300
2- The patient should be 50 to 75 years old
Conditions of non-entry:
1-Intubated patient
2- Uncontrolled HTN
3. Advanced heart or renal failure
4- COPD
Intervention groups
In the control group, patients receive all available supportive and specific therapies based on existing standards.
In the intervention group, in addition to similar treatments in the control group, patients were given 500 cc of freshly survivors plasma every other day up to 3 times.
Main outcome variables
1- The length of hospital stay in the ICU from the time of entering the study
2- The length of hospital stay from the time of entering the study
3- The need for mechanical ventilation from the time of entering the study
4 - Severity of the disease based on SOFA score
5- Severity of the disease based on Pao2 / Fio2 ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200409047007N1
Registration date:2020-04-12, 1399/01/24
Registration timing:prospective
Last update:2020-04-12, 1399/01/24
Update count:1
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Mohsen Seddigh-Shamsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 8818
Email address
seddighshamsim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-08-15, 1399/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of plasma administration of COVID-19 survivors in patients with acute respiratory distress syndrome due to COVID-19
Public title
Effect of COVID 19 survivors plasma in COVID 19 patients with ARDS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Po2 / FIO2 ratio less than 300 despite receiving standard treatment
The patient should be between 50 and 75 years old
Normal IgA level
Less than a week has passed since the patient entered the ICU
Exclusion criteria:
Uncontrolled HTN
Advanced heart failure
Systolic blood pressure less than 90 mm Hg
COPD
The patient is intubated
Chronic renal failure with GFR less than 30
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
16 patients will be randomly assigned to each of the intervention and control arms. Randomization is that after making specific sequences for each group using specialized software, the assigned code (for example, even / odd) is written on separate sheets. Each sheet is folded and sealed so that it is not visible inside. After each eligible patient enters the ICU, a sheet is opened in order, and according to the code in it (even / odd), the patient is placed in the control or intervention group.
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 Mashhad University of Medical Sciences
Street address
Central University Building, University Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-04-06, 1399/01/18
Ethics committee reference number
IR.MUMS.REC.1399.055
Health conditions studied
1
Description of health condition studied
COVID-19 Disease
ICD-10 code
U07.02
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
mortality rate in first month from the time of entry into the study
Timepoint
The first month of entering the study
Method of measurement
Continuous clinical evaluation
Secondary outcomes
1
Description
The length of hospital stay in the ICU from the time of entering the study
Timepoint
Daily evaluation
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group: In the intervention group, patients, in addition to the current standard treatments, also receive survivors plasma 500 cc each time. This treatment is started as soon as possible after the patient enters the ICU and within a week and is performed up to 3 times a day. For the preparation of fresh plasma products, survivors with 18 to 60 years old were contacted and tested for CRP, CBC, HBS Ag, HCV Ab, HIV Ab, HTLV1 Ab and COVID 19 PCR if they were without symptoms for at least 10 days. If all tests are normal, 500 cc plasma will be taken from them and are prescribed to patients in the ICU in less than 12 hours. Survivors should have a positive initial PCR test for coronavirus, be male, or have no history of pregnancy if they are female. The donor and the patient must be the same in blood group and Rh.
Category
Treatment - Other
2
Description
Control group: In the control group, patients benefit from all available supportive and specific therapies based on existing standards. Survivors plasma is not prescribed in this group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Imam Reza Hospital
Full name of responsible person
Dr Abolghasem Allahyari
Street address
Department of Internal Medicine, Taqi abad Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 8818
Email
allahyaria@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central University Building, University Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Seddigh Shamsi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Department of Internal Medicine, Taqi abad Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
seddighshamsim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Abolghasem Allahyari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Department of Internal Medicine, Taqi abad Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
allahyaria@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Seddigh Shamsi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Department of Internal Medicine, Taqi abad Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
seddighshamsim@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After collecting and analyzing the data, the results will be made available to the public in the form of articles.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
physicians
Under which criteria data/document could be used
There are no restrictions
From where data/document is obtainable
1- Dr Abolghasem Allahyari, Mashhad University of Medical Science
2- Dr Mohsen Seddigh Shamsi, Mashhad University of Medical Science
What processes are involved for a request to access data/document