Determining the effectiveness of plasmapheresis treatment in the treatment of patients with Coronavirus disease (COVID-19)
Design
Clinical trial, no control group, no randomization, phase 2 design of 100 patients
Settings and conduct
The study will be performed in critically ill patients with a diagnosis of Covid-19 disease admitted to the intensive care unit of Hazrat Rasoul Akram Hospital in Tehran in 1399. Symptoms will be monitored before and after plasmapheresis.
Participants/Inclusion and exclusion criteria
Coronavirus disease (COVID-19) admitted in the intensive care unit (ICU)
Intervention groups
Plasmaphereses at a dose of 60 mg per kg daily up to four doses
Main outcome variables
The status of fever, cough, dyspnea, oxygen saturation, lactate dehydrogenase, sedimentation and C-reactive protein in patients before and after plasmapheresis will be assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180316039112N3
Registration date:2021-02-01, 1399/11/13
Registration timing:retrospective
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
2020-06-21, 1399/04/01
Actual recruitment end date
2020-12-21, 1399/10/01
Trial completion date
2020-12-21, 1399/10/01
Scientific title
Plasmapheresis in the treatment of patients with COVID-19
Public title
Plasmapheresis in the treatment of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19
Exclusion criteria:
Patient dissatisfaction with inclusion in the study
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
120
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
Ethics committee of Iran University of Medical Sciences