Protocol summary
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Study aim
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Evaluation the efficacy of Anti- TNF on COVID-19
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Design
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In this simple clinical trial study, 80 patients with inclusion criteria will be selected by the non-randomized selection and divided in two balance group.
The two groups will be matched as the same gender, age and background disorders.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Altebrel 50 mg subcutaneously in 2 dose in one week.
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Main outcome variables
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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
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Reason for update
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because of difficulties in production of placebo, the control group have not taken placebo.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200312046749N1
Registration date:
2020-03-28, 1399/01/09
Registration timing:
registered_while_recruiting
Last update:
2020-04-12, 1399/01/24
Update count:
1
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Registration date
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2020-03-28, 1399/01/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-27, 1399/01/08
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Expected recruitment end date
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2020-09-29, 1399/07/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation the efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19 outcomes: a prospective clinical trial study.
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Public title
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Efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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>18 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.
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-24, 1399/01/05
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.034
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Improvement of pulmonary manifestations and the duration.
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Timepoint
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One week, two weeks and 6 months after
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Method of measurement
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physical examination, labratory data and CT scan
2
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Description
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Improvement the radiologic parameters.
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Timepoint
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after 7-10 days
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Method of measurement
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computed tomography
3
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Description
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Necessity and Duration to ICU admission and hospitalization
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Timepoint
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One to two weeks later
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Method of measurement
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Questionnaire
4
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Description
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Mortality
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Timepoint
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One month later
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Method of measurement
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Number
5
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Description
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The three months outcomes: complete improvement; improvement with transient complication; improvement with persistent complication
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Timepoint
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After three months
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Method of measurement
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Physical examination and history
Intervention groups
1
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Description
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Intervention group: altebrel 50mg by aryogen company subcutaneously in two dose with2-3 days duration in one week.
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Category
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Treatment - Drugs
2
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Description
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Control group: In control group, supportive care and protocol without any injection
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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vice chancellor for research
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Study protocol
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When the data will become available and for how long
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After finished sampling and data analysis
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To whom data/document is available
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The researchers in university
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Under which criteria data/document could be used
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Help in managing of patients
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From where data/document is obtainable
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The principal investigator
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What processes are involved for a request to access data/document
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Contact with the chief
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Comments
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