The purpose of this study is to determine the effect of Adalimumab on clinical symptoms of patients with COVID-19
Design
Phase II, single-blinded, randomized, parallel-group clinical trial on 100 patients
Settings and conduct
This study will be performed at Baqiyatallah hospital in Tehran. 50 patients receiving routine antiviral drug and chloroquine will receive 40 mg subcutaneous abdominal injection of Adalimumab. 50 control group patients receive only routine antiviral drug and chloroquine. Since this is a single-blind study, only patients participating in this study are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from COVID-19, Respiratory distress with over 30 breaths per minute, O2 saturation less than 93% at rest, PaO₂/Fio₂ less than 300 mmHg, HRCT indicating COVID-19, positive PCR test result.
Non-inclusion criteria: -
Intervention groups
Control group: Receiving standard antiviral treatment and Chloroquine.
Intervention group: Receiving drugs used in control group plus subcutaneous injection of 40 mg adalimumab into the periumbilical region
Main outcome variables
Disease severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171105037262N4
Registration date:2020-06-18, 1399/03/29
Registration timing:registered_while_recruiting
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
mohammadhossein pourhanifeh
Name of organization / entity
kashan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 0988
Email address
pourhanifeh-mh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-29, 1399/02/10
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adalimumab effect on clinical symptoms including respiratory distress, oxygen saturation and lung involvement of patients with COVID-19
Public title
Adalimumab effect on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having COVID-19
Respiratory distress with over 30 breaths per minute
O2 saturation less than 93% at rest
PaO₂/Fio₂ less than 300 mmHg
HRCT indicating COVID-19
positive PCR test result
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After specifying the sample size, blocks of size 4 consisting of A and B letters are formed (6 blocks). Then, each of the blocks is numbered 1 to 6 and based on the selected numbers from random numbers table, we form a sequence of blocks, in which the letters A and B are located, and then randomly one of the letters are considered as the drug group and the other letter as the control group. This method is referred to as "Permuted Blocked Randomization".
Blinding (investigator's opinion)
Single blinded
Blinding description
Since this is a single-blind study, our blindness would be single-blinded and only patients participating in this study are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Science
Street address
Mollasadra
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.BMSU.REC.1399.062
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Disease severity
Timepoint
At the beginning and end of the intervention
Method of measurement
According to protocol and clinical symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 patients with COVID-19 who receive routine antiviral treatment and chloroquine, have more than normal levels of TNF-α, and are at risk of critical disease statement (1-respiratory failure that needs mechanical ventilation, 2-shock, 3-any organ failure, 4-need to be admitted in ICU) will receive subcutaneous injection of anti-TNF-α (adalimumab), 40 mg, in periumbilical region of the abdomen. According to altered clinical and laboratory findings, mentioned dose can be repeated
Category
Treatment - Drugs
2
Description
Control group: 50 matched patients receiving equal antiviral treatment and chloroquine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Hassan Nikoueinejas
Street address
Mollasadra street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 1511
Email
hnikuinejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhossein Alishiri
Street address
Mollasadra
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
R.bmsu@yahoo.com
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
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hassan Nikoueinejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Mollasadra
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
hnikuinejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hassan Nikoueinejad
Position
Assosiate Professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Mollasadra
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
hnikuinejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Pourhanifeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ghotb-e-Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 0988
Email
mhph.lord.1996@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD