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IRCT20150303021315N17 IRCT 2020-04-12 Aryogen Pharmed Tocilizumab in severe COVID-19 Evaluation of the safety and efficacy of tocilizumab (AryoGen ‎Pharmed Co., Iran) in patients with severe COVID-19‎ 2020-03-15 anticipated 85 Complete https://irct.ir/trial/46550 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 COVID-19. Intervention group: Subcutaneous (two PFS injections of 162 mg Tocilizumab for ‎patients <100 kg and three PFS injections of 162 mg Tocilizumab for patients >100 kg) in addition to the standard treatment. In case of inadequate response, Tocilizumab would be re-administered with a 12-hour interval between injections.. 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 It is not yet known if there will be a plan to make this available
public Nassim Anjidani
No 42, Attar street, Vanak square
Tehran Iran (Islamic Republic of) 1651655 009843473000 anjidani.n@orchipharmed.com OrchidPharmed Co. scientific Dr. Payam Tabarsi
Masih Daneshvari Hospital, Darabad St., Bahonar St.,
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 payamtabarsi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) َAbility to comprehend and willingness to sign the informed consent form for this study by ‎the patient or his/her guardian Patients above 18 years old‎ Patients with fever higher than 37.8 °C, cough, shortness of breath, or respiratory rate higher than 30 breaths/min accompanied by SpO2 ≤ %93, who ‎have a confirmed diagnosis of SARS-CoV-2 infection using PCR and/or radiography.‎ Serum Interleukin-6 level ≥ 3 times upper limit of normal 18 years no limit Both History of hypersensitivity to Tocilizumab or any components of the formulation Hepatic disease (especially active hepatic diseases and hepatic impairment)‎ Patients with bone marrow suppression (defined as Absolute Neutrophil Count (ANC) below 2000/mm3 ‎or platelet count below 100,000/mm3)‎ Patients with a high risk of gastrointestinal perforation or with distinct history of GI disorders, e.g., active peptic ulcer and diverticulitis ‎ Patients with active or latent tuberculosis ‎ ‎Patients with history of active hepatitis B, hepatitis C, HIV, or any known immunodeficiency Pregnant or lactating patients Patients with any other active infection in addition to COVID-19 Patients with any other disease or disorder, which, in the opinion of the investigator will put the subject at risk, ‎if they are enrolled Renal impairment (GFR of below 30ml/min/1.73m2) U07.1 COVID-19 Treatment - Drugs Intervention group: Subcutaneous (two PFS injections of 162 mg Tocilizumab for ‎patients <100 kg and three PFS injections of 162 mg Tocilizumab for patients >100 kg) in addition to the standard treatment. In case of inadequate response, Tocilizumab would be re-administered with a 12-hour interval between injections. All-cause mortality rate during the study (date and cause of death, if applicable). Timepoint: day 1 through 14. Method of measurement: Physical Examination. Percent of patients with improvement in oxygenation. Timepoint: day 1 through 14. Method of measurement: Percent of patients with at least one step decrease in oxygenation supply; steps: 1. no need for supplemental oxygenation; 2. nasal catheter oxygen inhalation; 3. Mask oxygen inhalation; 4. Noninvasive ventilator oxygen supply; 5. Invasive ventilator oxygen supply. Duration (days) of hospitalization. Timepoint: day 1 thorough 14. Method of measurement: Clinical Evaluation. Changes in body temperature. Timepoint: Day 1 through 14. Method of measurement: Physical Examination. The lesions of the pulmonary segment numbers involved in pulmonary CT. Timepoint: Day 1 and 14. Method of measurement: CT scan. Duration (days) of mechanical ventilation. Timepoint: Day 1 through 14. Method of measurement: Clinical Evaluation. Changes in C-reactive protein blood level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test. Changes in Interleukin-6 blood levels. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test. Changes in White Blood Cell count. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test. Changes in cholesterol level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test. Changes in Aspartate transaminase level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test. Changes in Alanine transaminase level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test. Injection site reaction. Timepoint: Day 1 through 14. Method of measurement: Clinical evaluation. Gastrointestinal perforation. Timepoint: Day 1 through 14. Method of measurement: Clinical evaluation; radiographic imaging in case of clinical symptoms. Infection. Timepoint: Day 1 through 14. Method of measurement: Clinical evaluation, laboratory test, imaging. Changes in Platelet level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test. Changes in bilirubin level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test. Blood pressure. Timepoint: Day 1 through 14. Method of measurement: Blood pressure meter. Aryogen Pharmed Approved 2020-03-13 National Institution for Medical Research Development No 21, Beesat St., West Fatemi St. Tehran Tehran Iran (Islamic Republic of)