Determining and comparing the effectiveness of Tocilizumab and Infliximab in patients with Covid19
Design
The clinical trial has two parallel groups, one blind, non-random, phase 2-3 on 40 patientsمداخله
Settings and conduct
The intervention is performed for Covid19 patients with severe hospitalization in Shahrekord hospitals. One of the two drugs, tocilizumab and infliximab, are injected into patients at 8 mg and 5 mg per kg body weight, respectively, according to the treating physician. Patients are aware of receiving one of these two drugs but do not know which of the two
Participants/Inclusion and exclusion criteria
1. People aged 25-70 years with Covid19 (based on RT-PCR test for SARS-CoV-19 virus or CT scan criteria)
2. The presence of symptoms indicates the severity of the disease
3. ppd test, and markers of viral hepatitis are negative
4. No pregnancy
Intervention groups
Two groups of patients with severe covid19 disease who received conventional therapies received treatment with tocilizumab and infliximab (one drug in each group).
Main outcome variables
Ferritin; D-dimer; Lactate dehydrogenase; Complete blood cell count; Blood oxygen saturation; Reactive protein c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220208053970N1
Registration date:2022-03-12, 1400/12/21
Registration timing:registered_while_recruiting
Last update:2022-03-12, 1400/12/21
Update count:0
Registration date
2022-03-12, 1400/12/21
Registrant information
Name
Amir hossein koohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3230 5627
Email address
st-kouhi.a@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-12, 1400/12/21
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of ACTEMRA (TOCILIZUMAB) and REMICADE (INFLIXIMAB) in patients with Covid19
Public title
Effect of Toscilizumab and Infliximab on Covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with Covid 19 (based on RT-PCR test for SARS-CoV-19 virus or CT scan criteria)
People between the ages of 25 and 70
Symptoms indicate severe disease (more than 50% of lung involvement in CT or oxygen saturation below 90% or respiratory rate greater than 30 per minute)
Elevated CRP, ferritin and other inflammatory markers
Exclusion criteria:
People who test positive for PPD, HCV, HBV and have infections other than Covid 19 infection
Pregnancy and pregnancy intention
Mild involvement or in the early stages of Covid 19
Age
From 25 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients with Covid19 are divided into two groups and according to the treating physician, one of the drugs Tocilizumab and Infliximab is injected according to the inclusion criteria.
In this study, patients are aware and satisfied to receive one of these two drugs, but they are blind to which of these drugs, but the doctor and other research team are aware of which drug to receive by which group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences (Research Ethics Committee)
Street address
Hajar Hospital, Parastar Ave
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2022-01-25, 1400/11/05
Ethics committee reference number
IR.SKUMS.REC.1400.220
Health conditions studied
1
Description of health condition studied
covid19
ICD-10 code
U10
ICD-10 code description
covid19
Primary outcomes
1
Description
ferritin
Timepoint
Before the intervention and five days after receiving the drug
Method of measurement
Elisa
2
Description
d-dimer
Timepoint
Before the intervention and five days after receiving the drug
Method of measurement
Bio-Lis
3
Description
C-Reactive Protein
Timepoint
Before the intervention and five days after receiving the drug
Method of measurement
Bio-Lis
4
Description
Lactate Dehydrogenase
Timepoint
Before the intervention and five days after receiving the drug
Method of measurement
Bio-Lis
5
Description
complete blood count
Timepoint
Before the intervention and five days after receiving the drug
Method of measurement
sysmex
6
Description
Erythrocyte Sedimentation Rate
Timepoint
Before the intervention and five days after receiving the drug
Method of measurement
Sediman Reader
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group of patients with Covid19 who have received standard treatments ,receive tocilizumab brand name ACTEMRA and TEMZIVA from ROCHE PHARMA and ARIOGEN PHARMED factories at a dose of 8 mg / kg in one or two doses two days apart.
Category
Treatment - Drugs
2
Description
Intervention group 2: This group of patients with Covid19 who have received standard treatments, receive an infliximab brand name REMICADE from JANSSEN factory at a dose of 5 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Amirhossein Koohi Esfahani
Street address
Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3226 4841
Email
Info@skums.ac.ir
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Amirhossein koohi esfahani
Street address
Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Email
Kashani@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Esfandiar Heydarian
Street address
Building No. 2, University Headquarters.Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Amir hossein Koohi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
121Unit, Ghaem complex, Pars St, Shariati St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814658602
Phone
+98 31 3230 5627
Fax
Email
st-kouhi.a@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Amir hossein Koohi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
121Unit, Ghaem complex, Pars St, Shariati St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814658602
Phone
+98 31 3230 5627
Fax
Email
st-kouhi.a@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Amir hossein Koohi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
121Unit, Ghaem complex, Pars St, Shariati St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814658602
Phone
+98 31 3230 5627
Fax
Email
st-kouhi.a@skums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data from the study can be shared after being unidentified
When the data will become available and for how long
Access begins in the winter of 1401
To whom data/document is available
The data will be available to researchers and academics
Under which criteria data/document could be used
Access will be possible to assist with future studies and scientific reviews
From where data/document is obtainable
Contact Dr. Amir Hossein Koohi to receive data
amirh1391@gmail.com
What processes are involved for a request to access data/document
After introducing the applicant and stating the purpose of the information request, as well as the commitment not to use it anymore, it can be received via email.