Evaluation of the effect of tocilizumab on the recovery rate of patients with severe Covid 19 disease
Design
Single arm randomized clinical trial, without control group with a sample size of 15 people, phase 3 clinical tria
Settings and conduct
The place of the study is Razi Hospital in Ahvaz. Simple sampling of patients is done. It is a one-arm study and medicine is used
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Positive PCR test for covid- 19
-Hospitalization with pneumonia
-Lung involvement in lung imaging
-Oxygen saturation less than 90%
-High levels of interleukin 6
-Not participating in another study
Exclusion Criteria
-Pregnant or lactating women
-Severe liver disease
-Allergic reaction to the used drugs
-Neutrophils less than 500
-Platelets less than 50,000
-Intestinal diverticulosis or intestinal perforation
- Positive viral markers or positive tuberculosis skin test
Intervention groups
This study is a single arm and has only one intervention group that receives Tocilizumab injection at a dose of 8 mg per kg and a maximum dose of 400 mg as a single dose
Main outcome variables
Mortality rate, Hospitalized in the intensive care unit, Number of days hospitalized in the intensive care unit, Interleukin 6
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210408050899N1
Registration date:2021-05-25, 1400/03/04
Registration timing:registered_while_recruiting
Last update:2021-05-25, 1400/03/04
Update count:0
Registration date
2021-05-25, 1400/03/04
Registrant information
Name
Roohangize Nashibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 5935
Email address
dr.r.nashibi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-25, 1400/02/05
Expected recruitment end date
2021-05-31, 1400/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The effect of Tocilizumab on the recovery rate of patients with severe Covid 19 disease referred to Razi Hospital in Ahvaz
Public title
Evaluation of The effect of tocilizumab on patients with severe Covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR test for COVID- 19
Oxygen saturation less than 90%
Hospitalized with pneumonia
High levels of interleukin 6
Not participating in another study
Exclusion criteria:
Pregnant or lactating women
Severe liver disease (liver enzymes more than 5 times normal)
Allergic reaction to the used drugs
Neutrophils less than 500
Platelets less than 50000
Intestinal diverticulosis or intestinal perforation
Positive viral markers or positive tuberculosis skin test
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
15
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
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical
Street address
Ethics committee, main building, Ahvaz University of medical science, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6133744151
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.AJUMS.REC.1399.936
Health conditions studied
1
Description of health condition studied
Covid_19
ICD-10 code
U07.1
ICD-10 code description
Corona virus infection, unspecified
Primary outcomes
1
Description
Mortality rate
Timepoint
End of study
Method of measurement
Patient file
Secondary outcomes
1
Description
Hospitalized in the intensive care unit
Timepoint
End of study
Method of measurement
Patient file
2
Description
Number of days hospitalized in the intensive care unit
Timepoint
End of study
Method of measurement
Patient file
3
Description
Interleukin 6
Timepoint
Before and after the intervention
Method of measurement
Measuring kit
Intervention groups
1
Description
Intervention group: Patients who continue to have low oxygen saturation despite receiving antiviral drugs and corticosteroids receive tocilizumab. The drug tocilizumab made in China is Roche brand, which patients will receive at a dose of 8 mg per kilogram of body weight and a maximum dose of 400 mg as a single dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital, Ahvaz
Full name of responsible person
Rooh Angiz Nashibi
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
dr.r.nashibi@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdi Ahmadi moghadam
Street address
Main building, Ahvaz University of Medical Science, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3311 3815
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Rooh Angiz Nashibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
dr.r.nashibi@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Rooh Angiz Nashibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
dr.r.nashibi@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Rooh Angiz Nashibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
dr.r.nashibi@ajums.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
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