Protocol summary
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Study aim
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Evaluation of Tocilizumab (Actemra) effects on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients
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Design
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This study is a two arm parallel group, double blinded clinical trial in phase 2 which will be carried out on 40 hospitalized COVID-19 patients. Patients randomly divided into two groups (Control group and Tocilizumab group).
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Settings and conduct
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40 hospitalized COVID-19 patients in Shariati and Imam Khomeini hospitals will be included in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: COVID-19 patient confirmed by positive PCR test for SARS-CoV-19 or abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities), Blood oxygen saturation <93% or respiratory rate> 24, high CRP rate or lymphopenia<1100, and not responding to standard COVID-19 treatment.
Exclusion criteria: A history of malignancies, positive pro-calcitonin and active infection (Including latent or active TB infection), a history of taking immunosuppressive drugs and corticosteroids
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Intervention groups
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Control group: Will receive only standard treatment for COVID-19 disease. Tocilizumab group: In addition to standard treatment will receive 8mg/kg Tocilizumab.
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Main outcome variables
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Radiographic features findings, Mortality rate, O2 saturation, Need for an oxygen therapy and Laboratory tests
General information
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Reason for update
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Placebo elimination and and revise the exclusion criteria section
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20081027001411N4
Registration date:
2020-07-09, 1399/04/19
Registration timing:
registered_while_recruiting
Last update:
2021-01-27, 1399/11/08
Update count:
1
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Registration date
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2020-07-09, 1399/04/19
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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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2020-04-29, 1399/02/10
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Expected recruitment end date
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2020-07-31, 1399/05/10
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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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Study of Tocilizumab effect on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients: a crinical trial study
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Public title
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Effect of TOCILIZUMAB (ACTEMRA) on treatment of 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:
COVID-19 patients confirmed by positive PCR test for SARS-CoV-19
or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities),
With blood oxygen saturation <93%, or respiratory rate> 24
high CRP rate,
lymphopenia < 1100
not responding to standard COVID-19 treatment.
Exclusion criteria:
A history of malignancies, positive pro-calcitonin and active infection (Including latent or active TB infection)
A history of taking immunosuppressive drugs and corticosteroids
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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
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block Balanced Randomization Method will be used.
Patients will allocate to two groups with permuted balanced block randomization Method. The size of each random block is 4, and 10 blocks will be used for 40 patients. Patients will be allocated equally to the two intervention groups.
In this study permuted balanced block randomization will be used. In this permuted balanced block randomization, the blocked size is 4, the allocation ratio is 1, and the number of intervention groups is 2. After specifying the block size, all the potential contribution of the assignments within each group must be calculated, (block size is four, 6 possible balance combinations with two intervention group I and two intervention group II in each block are calculated ) and then the blocks are randomly chosen to determine the assignment of all participants. So, the total of the sample size of participants randomized to two treatment groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this randomized controlled parallel clinical trials study, the type of blindness is double-blind and the blindness level is partial blinding. Also, in this study, physicians, evaluators of patients, and patients themselves in the groups are not aware of the allocation concealment and the random allocation sequence was produced by the statistical consultant and only one person in the staff allocate the patients to treatment groups based on the sequence of random numbers.
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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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This study is double blinded clinical trial in phase 2 which will be carried out on 40 hospitalized COVID-19 patients. Patients randomly divided into two groups. Control group and treatment group which received of medicine (8mg/kg of Roche Tocilizumab). Clinical signs of patient including heart rate, blood pressure, fever, O2 saturation, laboratory tests result (CBC, Hb, HCT, FBS,TG, Cho, ESR, CRP, VBG, IL-6, Ferritin, CPK, ALT, AST, Troponin, and D-dimer) will be recorded before and after treatment (after 3-5 days of treatment and at discharge time). In addition, dyspnea, cough, GI Symptom, myalgia, and chest pain will be assessed before and after treatment (after 5 days of treatment and at discharge time). In addition, Patients' mortality rates, length of hospitalization, and the need for intubation and oxygen therapy (nasal Cannula, mask Oxygen, reserve Mask, NIV and invasive ventilation) will also be recorded before and after treatment (after 5 days of treatment and at discharge time).
Ethics committees
1
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Ethics committee
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Approval date
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2020-04-26, 1399/02/07
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.290
Health conditions studied
1
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Description of health condition studied
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COVID-19 disease
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ICD-10 code
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U07.2
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ICD-10 code description
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COVID-19, virus not identified
Primary outcomes
1
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Description
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Radiographic features Findings
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Timepoint
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Before treatment and 6 weeks after treatment
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Method of measurement
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CT scan
2
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Description
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Mortality rate
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Timepoint
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Before and after treatment
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Method of measurement
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Observation
3
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Description
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Need an oxygen therapy
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Timepoint
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Before and after (at day 5 after treatment and discharge time)
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Method of measurement
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The need on oxygen therapy (Yes or No), If yes: Type of oxygen therapy (nasal cannula, mask oxygen, reserve mask, noninvasive ventilation (NIV), and invasive ventilation)
4
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Description
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O2 saturation
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Timepoint
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Before and after (at day 5 after treatment and at discharge time)
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Method of measurement
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Pulse Oximeter
Secondary outcomes
1
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Description
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Laboratory tests (including CBC, Hb, HCT, FBS, TG, Cho, ESR, CRP, VBG, IL-6, Ferritin, CPK, ALT, AST, Troponin, and D-dimer)
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Timepoint
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Before and after (at day 5 after treatment and discharge time)
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Method of measurement
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Para-clinical
Intervention groups
1
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Description
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Intervention group: Patients hospitalized with COVID-19 disease will receive 8mg/kg Tocilizumab (Roche) in addition to their standard treatment. If the patients condition is not stable 2 doses by 12 hours will be administrated (maximum dose: 800 mg)
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients hospitalized with COVID-19 will receive standard care alone.
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Category
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Treatment - Other
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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Yes
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Title of funding source
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Tehran University of Medical Sciences
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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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be 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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Not applicable
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Title and more details about the data/document
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It will be published as an article
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When the data will become available and for how long
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After printing the article
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To whom data/document is available
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All medical professionals and scientiscts
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Under which criteria data/document could be used
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There is no restriction on access to information
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From where data/document is obtainable
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Dr. Ahmadreza Jamshidi, Tehran University of Medical Science
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What processes are involved for a request to access data/document
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Refer to the project supervisor
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Comments
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