Evaluation of the effect of plasma replacement on one-month mortality of patients
Design
Clinical trial with retrospective control group, non-randomized, phase 2 on 42 patients. Matching will be done by propencity score and will be controlled in regression models.
Settings and conduct
This study will be performed in the Intensive care units of Imam Reza Hospital in Mashhad. 42 patients enter study based on inclusion and exclusion criteria. In 21 patients, in addition to standard treatments, plasmapheresis is performed. The other 21 patients will be selected from the ICU admitted patients from April 2020 until the time of study begins. Study objectives will be evaluated on days 0, 3, 7 and finally on day 30 after ICU admission.Regression models and propensity score calculation will be used to ensure the homogeneity of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Patients over 15 years of age with definitive covid 19 based on positive PCR test,who have all of four criteria for acute respiratory distress syndrome and are available to enter the study with their (or their legal guardian) consent can enter the study. Patients with unstable hemodynamics or a history of myocardial infarction within 3 months before admission or history of allergies to blood products are not included in the study
Intervention groups
In the intervention group, in addition to standard treatments (but no IVIg, hemoperfusion and Tocilizumab) plasmapheresis done with fresh frozen plasma (FFP) at a rate of 10-20 cc per kg body weight, once a day for three days. In the control group, only standard treatments are used.
Main outcome variables
Death rate, length of stay in ICU, need for mechanical ventilation support, number of days of mechanical ventilation and ARDS severity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200405046958N2
Registration date:2021-04-14, 1400/01/25
Registration timing:registered_while_recruiting
Last update:2021-04-14, 1400/01/25
Update count:0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Mohammad Moeini Nodeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2742
Email address
moeininm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of therapeutic plasma exchange in patients with acute respiratory distress syndrome caused by Covid 19 disease
Public title
Evaluation of the effect of plasmapheresis in the treatment of Covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient must be definitive case of Covid-19 based on positive PCR test.
The patient must have clinical and paraclinical criteria for acute respiratory distress syndrome (ARDS)
The patient age must be over 15 years
There must be the informed consent of the patient or his/her legal guardian
Exclusion criteria:
The patient has unstable hemodynamics
The patient has a history of previous acute cardiac infarction in the last 3 months
The patient has a history of allergies to blood products
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study,the control group will be retrospective and the previous data will be used, matching is done based on propensity score matching and this index is used in regression models to adjust for potential confounders.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Intervention group: Patients who underwent plasmapheresis for 3 days in addition to routine treatment (Includes ventilation supportive care, serum therapy, treatment with heparin or enoxaparin, famotidine or pantoprazole, low-dose dexamethasone, remdesivir, atorvastatin, and antibiotics if needed)
Category
Treatment - Other
2
Description
Control group: Patients who receive only the usual treatments listed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital in Mashhad, ICU ward
Full name of responsible person
Mohammad Moeini Nodeh
Street address
Imam Reza Hospital., Ibn Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9186744163
Phone
+98 51 3802 2370
Email
MoeiniNM@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Dadgar
Street address
ghorayshi bilding., Daneshgah st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
Vresaerch@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
Mohammad Moeini nodeh
Position
َAssistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
internal medicine department., Ghaem hospital., ahmadabad St
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Fax
+98 51 3845 3239
Email
MoeiniNM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moeini Nodeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology oncology
Street address
Ghaem hospital., Ahmad abad St
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Fax
+98 51 3845 3239
Email
MoeiniNM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moeini Nodeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
ghaem hospital., Ahmadabad St
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Fax
+98 51 3845 3239
Email
MoeiniNM@mums.ac.ir
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
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
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
Title and more details about the data/document
Some of the data can be shared if the patients' privacy is respected and with the permission of the ethics committee.
When the data will become available and for how long
At the end of the study up to two years later.
To whom data/document is available
Any researcher who submits a written request to the corresponding author and can convince the researchers to share the information.
Under which criteria data/document could be used
Observance of research ethics, protection of participants' privacy and permission of the Medical Ethics Committee.
From where data/document is obtainable
Corresponding author.
What processes are involved for a request to access data/document
Send email and provide sufficient reasons and permission of the Medical Ethics Committee.