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IRCT20201024049134N2 IRCT 2021-06-04 Babol University of Medical Sciences Efficacy of tocilizumab in the treatment of hospitalized patients with COVD-19 Efficacy of Tocilizumab in Hospitalized Patients with COVID-19: An open-label placebo-controlled clinical study 2021-06-22 anticipated 60 Complete https://irct.ir/trial/56613 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Unit randomization is done by block method with a block size of 4. For each of the 6 possible cases for the quadruple block, the numbers are assigned as follows AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6). With the help of a table of random numbers, the numbers between 1 and 6 are selected, and the treatment allocation list is determined according to each number. To execute the generated random sequence, the method of hiding coded boxes or cans is used. In this method, the cans are numbered in a random sequence. Inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written is provided to the executor with the condition that the boxes are completely sealed. The researcher assigns patients to the standard intervention and treatment group based on patients' admission orders. Tools: Create random sequences of 4 random blocks Concealment to execute random sequences on study participants will be done. How to make blocks: Randomly select the block and read the letters from right to left. Hiding will be done by the method of cans that are numbered in random sequence. The cans are the same weight and shape and will be prepared by an independent researcher. 3 COVID-19. Intervention 1: Control group: Patients in this group receive a placebo at a dose of 8 mg/kg (up to a maximum dose of 800 mg/kg) by two consecutive intravenous infusions 12 hours apart in addition to standard treatment based on national guidelines for the treatment and management of COVID-19. Intervention 2: Intervention group: Patients in this group receive tocilizumab at a dose of 8 mg/kg (up to a maximum dose of 800 mg/kg) by two consecutive intravenous infusions 12 hours apart in addition to standard treatment based on national guidelines for the treatment and management of COVID-19. Yes - There is a plan to make this available What will be shared: All participants' personal data can be shared after the anonymization of individuals. When: Six months after the end of the study and publication of the article To whom: The data of this study will be available only to researchers working in academic and scientific institutions. Conditions: There are no specific preconditions. Where to obtain: They should send their request to the person in charge of the study, Dr. Mostafa Javanian, with the e-mail address: mjavanian@gmail.com. How to obtain: On average, it will take two weeks to process the application. Comments:
public Mohammad Barary
No. 88, Khosravan ave., Moallem 12 st., Shariaty blvd.
Babol Iran (Islamic Republic of) 4714743568 +98 11 3236 0124 m.barary@mubabol.ac.ir Babol University of Medical Sciences scientific Mostafa Javanian
Vice-Chancellor for public health affairs, Shahid Modarres blvd.
Babol Iran (Islamic Republic of) 4714934937 +98 11 3233 6875 mjavanian@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Men and women of at least 18 years of age capable of providing informed consent. Confirmation of COVID-19 with RT-PCR. Need for hospitalization. No need for mechanical ventilation. No need to more than 10 L/min of supplemental oxygen by any device. Being in a severe COVID-19 phase (at least 2 of the following): Fever > 38 ° C in the last 72 hours, Evidence of pulmonary involvement on chest x-ray (50% progression in the last 48 hours), Dependence on supplemental oxygen to maintain a blood oxygen saturation > 90% Having at least one of the following: CRP > 50 mg/L, LDH > 350 U/L, D-Dimer > 1000 ng/mL 18 years no limit Both Patients more than 70 years of age with a history of any of the following in the last six months: Class III / IV Heart Failure Based on the New York Heart Association (NYHA) classification, Insulin-dependent diabetes, Angina pectoris, Malignancy Uncontrolled bacterial, fungal, or viral infection (other than COVID-19). Active TB Any history of any progressive neuromuscular disease. Any previous history of treatment with immunosuppressive medications in the last 28 days. Concomitant use of any immunosuppressive drug that puts the patient at greater clinical risk. Any history of allergy to Tocilizumab. Any history of receiving convalescent plasma therapy Any history of intestinal diverticulitis or perforation Absolute neutrophil count (ANC) < 500 or platelets < 50,000 AST or ALT > 5 times the upper limits of normal Pregnant women or those intending to become pregnant in the next 90 days Breastfeeding women U07.1 COVID-19, virus identified Placebo Treatment - Drugs Control group: Patients in this group receive a placebo at a dose of 8 mg/kg (up to a maximum dose of 800 mg/kg) by two consecutive intravenous infusions 12 hours apart in addition to standard treatment based on national guidelines for the treatment and management of COVID-19. Intervention group: Patients in this group receive tocilizumab at a dose of 8 mg/kg (up to a maximum dose of 800 mg/kg) by two consecutive intravenous infusions 12 hours apart in addition to standard treatment based on national guidelines for the treatment and management of COVID-19. The time from the administration of the agent or placebo to the need for mechanical ventilation and intubation or death for whom died before intubation (within 28 days). Timepoint: 4, 7, 14, 21 and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team. Time since prescribing the investigated agent or placebo to the deterioration of patient status for one degree (for patients with a score of ≥ 3 on the clinical improvement scale at the time of enrollment) or two degrees (for patients with a score = 2 on the clinical improvement scale at the time of enrollment). Timepoint: 4, 7, 14, 21, and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team. Time since the administration of the study agent or placebo to when the patients with a score of ≥ 3 on the clinical improvement scale at the time of enrollment do not require oxygen supplementation (within 28 days). Timepoint: 4, 7, 14, 21, and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team. Babol University of Medical Sciences Approved 2021-05-31 Research Ethics Committee of Babol University of Medical Sciences GanjAfrooz Blvd. Babol Mazandaran Iran (Islamic Republic of)