Evaluation of the efficacy and safety of Adalimumab and Methylprednisolone pulse therapy in treatment of Covid-19 patients with ARDS
Design
This study is a two arm parallel group, randomized clinical trial in phase 2 which will be carried out on 40 hospitalized COVID-19 patients. Patients randomly divided into two groups.
Settings and conduct
This clinical trial will be carried out on 40 hospitalized COVID-19 patients in Intensive care unit of imam Reza hospital of AJA university of medical sciences, Iran. Patients will be received 1000mg Methylprednisolone pulse for 3 days and single 40 mg dose of Adalimumab.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients admitted to ICU with moderate to severe Covid-19 infection needs respiratory support PaO2/FiO2 less than 300 Progression of disease severity and not responding to standard treatment Prediction of intubation need in next 24 hours and LDH more than 450 Exclusion Criteria: Uncontrolled diabetes mellitus Active bacterial, fungal infection Procalcitonin more than 0.5 History of hypersensitivity to corticosteroids Active GI bleeding
Intervention groups
Control group: receive standard regimen for COVID-19 Intervention group: receive standard regimen for COVID-19 plus Methylprednisolone (1000 mg for 3 days) and Adalimumab (single stat 40 mg dose).
Main outcome variables
Changes in respiratory distress Changes in O2 Saturation Extubation Discharge from ICU Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200406046963N2
Registration date:2021-07-31, 1400/05/09
Registration timing:registered_while_recruiting
Last update:2021-07-31, 1400/05/09
Update count:0
Registration date
2021-07-31, 1400/05/09
Registrant information
Name
Reza Mosaed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8609 6001
Email address
reza.mosaed@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-18, 1400/03/28
Expected recruitment end date
2021-09-19, 1400/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of Adalimumab and methylprednisolone pulse therapy in treatment of Covid-19 patients with ARDS
Public title
Evaluation of the efficacy and safety of Adalimumab and methylprednisolone pulse therapy in treatment of Covid-19 patients with Acute respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with moderate to severe Covid-19 admitted to ICU
PaO2/FiO2 Less than 300
LDH more than 450
Progression of disease severity and not responding to standard treatment
prediction of intubation for next 24 hours
Exclusion criteria:
Uncontrolled diabetes mellitus
Active GI bleeding
history of corticosteroid hypersensitivity
sever electrolyte imbalances
Procalcitonin more than 0.5
active bacterial, viral ( HIV, Hepatitis) and fungal infection
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random allocation software and allocate patients to two groups of investigation (A) and control (B)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
Etemadzadeh Ave, west Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-05-19, 1400/02/29
Ethics committee reference number
IR.AJAUMS.REC.1400.032
Health conditions studied
1
Description of health condition studied
COVID-19 Disease
ICD-10 code
U07.2,
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Mortality rate
Timepoint
from including to study to 60 days
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients hospitalized with COVID-19 disease who in addition to their standard treatment ( Hydroxychloroquine 400mg daily) will be received 1000mg/day Methylprednisolone for 3 days and a stat 40 mg dose of Adalimumab.
Category
Treatment - Drugs
2
Description
Control group: Patients hospitalized with COVID-19 disease who are received standard treatment ( Hydroxychloroquine 400mg daily)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Ebrahim Hazrati
Street address
Etemadzadeh Ave, west Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 5072
Email
dr.hazrart.e@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ramin Hamidi Farahani
Street address
Etemadzadeh ave, west Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Rgsramin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Ebrahim Hazrati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh Ave, west Fatemi st
City
Tehran
Province
Tehran
Postal code
14117118541
Phone
+98 21 8609 6350
Email
dr.hazrart.e@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ebrahim hazrati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh Ave, west Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
dr.hazrart.e@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Mosaed
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Etemadzadeh Ave, west Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6001
Email
reza.mosaed@ajaums.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
not shared
When the data will become available and for how long
After acceptance of a journal
To whom data/document is available
All medical professionals and scientiscts
Under which criteria data/document could be used
There is no restriction on access to information
From where data/document is obtainable
Dr.Ebrahim Hazrati, AJA University of Medical sciences
What processes are involved for a request to access data/document