Protocol summary
-
Study aim
-
Investigating the efficacy and safety of Plasmapheresis in patients with moderate to severe COVID-19
-
Design
-
This study is a single-center, randomized, open-labeled, controlled and parallel .
-
Settings and conduct
-
Patients who is admitted to Baqiyatallah hospital and is meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation;The patient/Legal guardian has written consciously and freely consent to participate in the study; The patient has moderate to severe Corona-Virus associated pneumonia; In the first 48 hours of hospitalization, the patient did not show an improving trend; In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital.
Exclusion Criteria:
Multi organ failure; Pregnancy; Lactation.
-
Intervention groups
-
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
Control group: Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
-
Main outcome variables
-
Need to receive ICU service
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20080901001165N58
Registration date:
2020-05-27, 1399/03/07
Registration timing:
registered_while_recruiting
Last update:
2020-07-27, 1399/05/06
Update count:
1
-
Registration date
-
2020-05-27, 1399/03/07
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-04-29, 1399/02/10
-
Expected recruitment end date
-
2020-06-30, 1399/04/10
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Investigating the efficacy and safety of Plasmapheresis in patients with Moderate to severe COVID-19
-
Public title
-
Investigating the efficacy and safety of Plasmapheresis in patients with Moderate to severe COVID-19
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
The patient/Legal guardian has written consciously and freely consent to participate in the study;
The patient has moderate to severe Corona-Virus associated pneumonia;
In the first 48 hours of hospitalization, the patient did not show an improving trend;
In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;
Exclusion criteria:
Multi organ failure;
Pregnancy;
Lactation.
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
100
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Block Randomization method is used to randomized the patients.
In this method, the number of people assigned to each group is usually almost equal. Blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as witnesses. The main goal in this method is to balance the number of participants in each group.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-04-26, 1399/02/07
-
Ethics committee reference number
-
IR.BMSU.REC.1399.119
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
-
Need to receive ICU service (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12)
-
Timepoint
-
The patient is monitored every 6 hours, but the results are recorded daily in the checklist.
-
Method of measurement
-
Physical assessment
Secondary outcomes
1
-
Description
-
Mortality rate
-
Timepoint
-
30 days after including the study
-
Method of measurement
-
Physical assessment
2
-
Description
-
Length of hospitalization
-
Timepoint
-
The first day and the end of hospitalization
-
Method of measurement
-
The hospital record review
3
-
Description
-
Radiologic response
-
Timepoint
-
At the admission, before the discharge
-
Method of measurement
-
lung CT-SCAN
4
-
Description
-
Laboratory changes
-
Timepoint
-
Daily
-
Method of measurement
-
Blood sample, laboratory analysis
5
-
Description
-
Fever
-
Timepoint
-
Daily
-
Method of measurement
-
Thermometer
6
-
Description
-
Respiratory distress
-
Timepoint
-
Daily
-
Method of measurement
-
Clinical assessment
7
-
Description
-
Oxygen saturation without receiving oxygen supplement
-
Timepoint
-
It will be measured every 6 hours, but will be recorded daily
-
Method of measurement
-
Pulse-oxymetery device
Intervention groups
1
-
Description
-
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
-
Category
-
Treatment - Other
2
-
Description
-
Control group: Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virusfor the treatment of new corona-virus
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Bagheiat-allah 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
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
-
Undecided - It is not yet known if there will be a plan to make this available