The effect of plasmapheresis on inflammatory cytokines and pulmonary function in patients with severe COVID-19
Design
In this phase II clinical trial study with no blinding and randomization and control group, patients with severe respiratory disease of COVID-19 who are hospitalized in Imam khomeini hospital of Sari and Taleghani hospital of Tehran, as the intervention group, will be under three rounds of plasmapheresis treatment.
Settings and conduct
Blinding doesn't apply for this study and there is only one group of intervention that includes patients with severe respiratory disease of emerging corona virus in Imam Khomeini hospital that will be under treatment with plasmapheresis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: respiration rate more than 30 times per minutes, Partial pressure of arterial oxygen/Fraction of inspired oxygen (pao2/fio2) less than 300 mmHg and the need for mechanical ventilation.
Exclusion criteria: Invasive Mechanical Ventilation more than 7 days
Intervention groups
The intervention group will receive plasmapheresis in 3 consecutive days. First round will be after assessment of patients based on inclusion and exclusion criteria, the second and third round will be 12 and 24 hours after the first round, respectively
Main outcome variables
The level of interleukin 6 and 10 and tumor necrosis alpha before and after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210315050710N1
Registration date:2021-05-10, 1400/02/20
Registration timing:registered_while_recruiting
Last update:2021-05-10, 1400/02/20
Update count:0
Registration date
2021-05-10, 1400/02/20
Registrant information
Name
Mohammad Eslami Jouybari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 4044
Email address
mo.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of plasmapheresis on inflammatory cytokines and pulmonary function in patients with severe COVID-19
Public title
Evaluation of the effect of plasmapheresis on patients with severe COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men or women 18 to 80 years old
Informed consent by the phone call from relatives or legal representative
Diagnosis of COVID-19 by polymerase chain reaction in nasopharynx smear, sputa, or bronchial aspiration
Hospitalization in intensive care unit under invasive mechanical ventilation
Acute respiratory distress syndrome (sudden and acute hypoxia Pao2/Fio2<300) and (pulse oximetry Sao2<50%)
Lung bilateral opacity in computed tomography scan (during 24-48 hours that is not related to congestive heart failure)
Severe pneumonia which is accompanied with fever or respiratory infection)
D-dimer higher than 1000 ng/m
Ferritin higher than 500 µg/L
Exclusion criteria:
Being under invasive mechanical ventilation more than 7 days
Cirrhosis (de-compensated)
Chronic renal failure that needs dialysis
Active neoplastic disease
Severe congestive heart failure (class III-IV based on The New York Heart Association {NYHA Classification})
Severe Pulmonary Disease (Sever Pulmonary Disease (GOLD III – IV))
Pregnancy
Human Immunodeficiency Virus (HIV)
Patients who are involved in another clinical trial
Patients with high mortality who their physician believes they are expected to succumb to disease during next 24 hours
Pulmonary embolism confirmation
Patients with acute coronary syndrome
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences, Moalem Sq
Before intervention, 24 and 120 hours after intervention
Method of measurement
Spectrophotometer machine
2
Description
Lung function by oxygen saturation (SPO2) level
Timepoint
Before intervention and 24 hours after intervention
Method of measurement
Spirometry machine
Secondary outcomes
1
Description
Patient's recovery or death
Timepoint
Till 10 days after intervention
Method of measurement
Patient's follow-up and their clinical status
2
Description
Transferring patients to the ICU
Timepoint
Till 10 days after intervention
Method of measurement
Patient's follow-up
3
Description
Evaluation of Ferritin level in blood
Timepoint
Before and after intervention
Method of measurement
Spectrophotometer machine
4
Description
C reactive protein level in blood
Timepoint
Before and after intervention
Method of measurement
Biochemistry auto analyzer
5
Description
C3 and C4 level
Timepoint
Before and after intervention
Method of measurement
Spectrophotometer machine
6
Description
Complement Total (CH50) level in blood
Timepoint
Before and after intervention
Method of measurement
Spectrophotometer machine
7
Description
Duration of hospitalization in the intensive care unit (ICU)
Timepoint
Till 10 days after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: will receive plasmapheresis in 3 consecutive days; first round after assessment of patients based on inclusion and exclusion criteria, second and third rounds 12 and 24 hours after intervention, respectively. Blood flow rate will be 200-250 ml/minutes and 40 ml/kg. The blood will be replaced with 2/3 fresh frozen plasma and 1/3 normal saline.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohamad Eslami Jouybari
Street address
Imam Khomeini Hospital, Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 4044
Email
drsinaeslami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences, Moalem Sq.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
Pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Eslami Jouybari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology and adult oncology
Street address
Imam Khomeini Hospital, Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 4044
Email
drsinaeslami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Eslami Jouybari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology and adult oncology
Street address
Imam Khomeini Hospital, Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 4044
Email
drsinaeslami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Eslami Jouybari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology and adult oncology
Street address
Imam Khomeini Hospital, Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 4044
Email
drsinaeslami@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
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be available to public with no name mentioned.
When the data will become available and for how long
The date to access to data will be after the publication of the results.
To whom data/document is available
All data will be available to public.
Under which criteria data/document could be used
All data will be available to others under valid and scientific analysis supervision.
From where data/document is obtainable
To access data, contact with the primary investigator on drsinaeslami@gmail.com.
What processes are involved for a request to access data/document
After sending the request to the primary investigator (PI) (drsinaeslami@gmail.com), the request will be considered by PI and the Vice Chancellor for Research and Technology of Mazandaran University of medical Sciences.