In this simple clinical trial study, 80 patients with inclusion criteria will be selected by the randomized complete block design and divided in two balance group.
The two groups will be matched as the same gender, age and background disorders.
Settings and conduct
The blood glucose, CBC, ESR, CRP, LFT will be checked for all patients according to hospital protocols. The LFT and blood glucose will be checked again one week and 10 days after injection of medicine and placebo.
The radiologic evaluation with CT scan will be done in all patients according to the hospital protocols. The second CT one week later, will depend on the patient̓ s situation.The data will be documented in the anonymous questionnaire with special codes for each person.
Participants/Inclusion and exclusion criteria
Confirmed the COVID-19 disease with one or more of these: fever, dry cough, dyspnea and one or more of below: positive SARS-COV2 PCR; characteristic changes of SARS-COV2 in chest CT; age>18 years old; signing inform consent; no history of diabet , heart failure, TB and the other chronic disease.
Exclusion criteria: administration of corticosteroids pulses and/or IVIG in the disease process or one month after anti-TNF prescription; unwillingness of involved patients.
Intervention groups
Altebrel 50 mg subcutaneously in 2 dose in one week.
Main outcome variables
Improvement of pulmonary manifestations and the duration of it;Improvement the radiologic parameters; necessity to ICU admission; duration the ICU admission; duration the hospitalization; the mortality; the time of mortality; the three months outcomes: complete improvement; improvement with transient complication; improvement with persistent complication; death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200312046749N1
Registration date:2020-03-28, 1399/01/09
Registration timing:registered_while_recruiting
Last update:2020-03-28, 1399/01/09
Update count:1
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Raheleh Assari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8443
Email address
r1assari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-27, 1399/01/08
Expected recruitment end date
2020-09-29, 1399/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19 outcomes: a prospective clinical trial study.
Public title
Efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed the COVID-19 disease with one or more of these: fever, dry cough, dyspnea and one or more of below: positive SARS-COV2 PCR • Characteristic changes of SARS-COV2 in chest CT scan such as bilateral ground grass opacity in bases of the lungs ( confirmation with the radiologist)
Age>15 years old
Signing inform consent from the patient or patient̓ s accompaniment
No manifestations of bacterial infection
No history of rheumatologic disorders
No history of cancer for the last 1 year.No history of immunodeficiency (primary or acquired)
No manifestations, history and radiologic parameters according to active or latent TB
No diabetes or autoimmune hepatitis
No uveitis
No history of immunosuppressive treatment in the last 6 months
No history of growth hormone, Testosterone and any Anabolic steroids in the last one month
No history of Corticosteroid therapy (>30 mg/m2) for > 5 days in the last one month
No history of Corticosteroid pulses or IVIG treatments for last one month
No history of Biologics treatment for the last 6 months
Exclusion criteria:
Administration of corticosteroids pulses and/or IVIG in the disease process or one month after anti-TNF prescription.
Unwillingness of involved patients to continue this research.
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized Complete Block Design. The patients are selected as a randomized block table. So, the randomization in both group and in each phases of the research are equivalent.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this simple clinical trial study, 80 patients with inclusion criteria will be selected by the randomized complete block design and divided in two balance group.
The two groups will be matched as the same gender, age and background disorders. The antiviral protocols in the treatment of COVID-19 will be the similar in both groups consisted of; tablet hydroxychloroquine 400 mg daily, tablet lupinavir/ritonavir 50/200 two tablets twice a day for 5 days. In the case group, anti-TNFα (Altebrel: The brand name drug) made by Aryogen pharmed company will be added 50 mg in one week in two doses with 2-3 days interval subcutaneously in deltoid region, to the main protocol. In control group, the similar injection will be done by distilled water. The other interventions and treatments will be exactly similar in both groups. Cooperation in this research will be voluntarily in two groups by signing the informed consents. The evaluation of effectiveness, complications and outcomes will be documented in both groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran university of medical sciences
Street address
No.226,Qods St., Keshavarz Blvd., Tehran, Iran
City
tehran
Province
Tehran
Postal code
02181633698
Approval date
2020-03-24, 1399/01/05
Ethics committee reference number
IR.TUMS.VCR.REC.1399.034
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Improvement of pulmonary manifestations and the duration.
Timepoint
One week, two weeks and 6 months after
Method of measurement
physical examination, labratory data and CT scan
2
Description
Improvement the radiologic parameters.
Timepoint
after 7-10 days
Method of measurement
computed tomography
3
Description
Necessity and Duration to ICU admission and hospitalization
Timepoint
One to two weeks later
Method of measurement
Questionnaire
4
Description
Mortality
Timepoint
One month later
Method of measurement
Number
5
Description
The three months outcomes: complete improvement; improvement with transient complication; improvement with persistent complication
Timepoint
After three months
Method of measurement
Physical examination and history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: altebrel 50mg by aryogen company subcutaneously in two dose with2-3 days duration in one week.
Category
Treatment - Drugs
2
Description
Control group: In control group, the similar injection will be done by distilled water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
raheleh assari
Street address
Bagherkhan street
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8443
Email
r1assari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
vahid ziaee
Street address
No62 Dr Gharib St. Keshavars Blvd, Tehran 14194,Iran
City
tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8443
Email
ziaee@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
vice chancellor for research
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vahid Ziaee
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Markaz Tebi Atfal hospital, Dr. Gharib street
City
tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6692 0981
Email
ziaee@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raheleh Assari
Position
assisstand professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children Medical Center, Dr Gharib St.
City
Tehran
Province
Tehran
Postal code
1971844458
Phone
+98 21 6694 8443
Email
r1assari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raheleh Assari
Position
assistant proffessor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children Medical centre, Dr Gharib street
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8443
Email
r1assari@yahoo.com
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Study protocol
When the data will become available and for how long
After finished sampling and data analysis
To whom data/document is available
The researchers in university
Under which criteria data/document could be used
Help in managing of patients
From where data/document is obtainable
The principal investigator
What processes are involved for a request to access data/document