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IRCT20081027001411N4 IRCT 2020-07-09 Tehran University of Medical Sciences Effect of TOCILIZUMAB (ACTEMRA) on treatment of COVID-19 Study of Tocilizumab effect on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients: a ‎crinical trial study 2020-04-29 anticipated 40 Complete https://irct.ir/trial/48396 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: 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). ‎, Randomization description: 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, Blinding description: 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. ‎. 2 COVID-19 disease. Intervention 1: 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). Intervention 2: Control group: Patients hospitalized with COVID-19 will receive standard care alone. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Ahmadreza Jamshidi
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1313514117 +98 21 8822 0065 jamshida@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mahdi Mahmoudi
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8822 0065 mahmoudim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years no limit Both A history of malignancies, positive pro-calcitonin and active infection (Including latent or active TB infection) A history of taking immunosuppressive drugs and corticosteroids U07.2 COVID-19, virus not identified Treatment - Drugs Treatment - Other 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) Control group: Patients hospitalized with COVID-19 will receive standard care alone. Radiographic features Findings. Timepoint: Before treatment and 6 weeks after treatment. Method of measurement: CT scan. Mortality rate. Timepoint: Before and after treatment. Method of measurement: Observation. Need an oxygen therapy. Timepoint: Before and after (at day 5 after treatment and discharge time). Method of measurement: 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)‎. O2 saturation. Timepoint: Before and after (at day 5 after treatment and at discharge time). Method of measurement: Pulse Oximeter. Laboratory tests (including CBC, Hb, HCT, FBS, TG, Cho, ESR, CRP, VBG, IL-6, Ferritin, CPK, ALT, AST, Troponin, and D-dimer). Timepoint: Before and after (at day 5 after treatment and discharge time). Method of measurement: Para-clinical. Tehran University of Medical Sciences Approved 2020-04-26 Vice-Chancellor in Research Affairs Tehran University of Medical Science Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)