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IRCT20150303021315N22 IRCT 2021-01-27 Tehran University of Medical Sciences Adalimumab effectiveness in COVID-19 Evaluating the efficacy and safety of Adalimumab in patients with COVID-19 2020-07-04 anticipated 40 Complete https://irct.ir/trial/46955 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be assigned to treatment groups using a stratified randomization by R-CRAN software version 4.0.3. Blocks (with the size 2 or 4) will be made using permuted block randomization for a total of 40 patients with 1:1 allocation ratio. stratification is performed by sex (2 levels) and age (18-40 and 40-60). The randomization number will be assigned in a consecutive way. 2 COVID-19. Intervention 1: Intervention group: The intervention group, in addition to standarad treatment, receives 80 mg of adalimumab (with the concentration of 40mg/0.8ml) produced by Cinnagen Company (CinnoRA®) subcutaneously and as a single dose. Standard treatment: Oxygen therapy, using a mask or nasal cannula based on the patients' O2 saturation. Corticosteroids (if more than 5 days since the onset of symptoms have passed or SatO2 without adjuvant oxygen is below 90) are prescribed for a maximum of 2 weeks as following: Dexamethasone 6-8 mg/day or Prednisolone 0.5 mg/kg/day (max: 40mg). Anticoagulants, including heparin or enoxaparin: Subcutaneous enoxaparin in patients with GFR above 30:For BMI below 30=40mg/day subcutaneously, For BMI above 30=60mg/day subcutaneously or Heparin 5000U, TDS subcutaneously. Due to the lack of conclusive evidence for effectiveness of antiviral therapies in hospitalized patients with COVID-19, one of these antivirals including Lopinavir/Ritonavir, Atazanavir or Remdesivir may be prescribed based on physician’s decision. Intervention 2: Control group: The control group receives standard treatment including the following: Oxygen therapy, using a mask or nasal cannula based on the patients' O2 saturation. Corticosteroids (if more than 5 days since the onset of symptoms have passed or SatO2 without adjuvant oxygen is below 90) are prescribed for a maximum of 2 weeks as following: Dexamethasone 6-8 mg/day or Prednisolone 0.5 mg/kg/day (max: 40mg). Anticoagulants, including heparin or enoxaparin: Subcutaneous enoxaparin in patients with GFR above 30:For BMI below 30= 40mg/day subcutaneously, For BMI above 30= 60mg/day subcutaneously or Heparin 5000U, TDS subcutaneously. Due to the lack of conclusive evidence for effectiveness of antiviral therapies in hospitalized patients with COVID-19, one of these antivirals including Lopinavir/Ritonavir, Atazanavir or Remdesivir may be prescribed based on physician’s decision. 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 Sharing policy is still unknown
public Mona Talschian
Shariati Hospital, Jalal Al-Ahmad Hwy, North Kargar St.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 shariatihosp@tums.ac.ir Tehran University of Medical Sciences scientific Ahmadreza Jamshidi
Tehran university of medical science,
Tehran Iran (Islamic Republic of) 1417613151 +98 21 6640 5357 jamshida@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with the ability to comprehend and willingness to participate in the trial‎. Patients who are at least 18 years old at the beginning of trial. Patients with Fever higher than 37.8 C, Cough, shortness of breath accompanied by SpO2 ≤%93, who ‎have a confirmed diagnosis of SARS-CoV-2 infection using RT-PCR. patients with increased level of TNF-alpha to 3 times as much as normal range or with remarkable increase in CRP or Ferritin. 18 years no limit Both Patients attending other clinical trials at the same time. patients who are pregnant or breastfeeding. patients with (ALT/AST> 5ULN, ANC <0.5 (x109/L), Platelet count<50 (x109/L) based on laboratory findings. People with active immune-related rheumatic diseases who have been treated with anti-TNF medications for the last 6 months. People taking immunosuppressive drugs. People who are allergic to adalimumab or other components of the formulation of these drugs. People with active pulmonary tuberculosis or other active bacterial or fungal infections (Based on IGRA, procalcitonin and blood culture) People with heart failure (grades 3 and 4 of NYHA). History of demyelinating diseases in the patient or his/her family U07.1 C0VID-19 Treatment - Drugs Placebo Intervention group: The intervention group, in addition to standarad treatment, receives 80 mg of adalimumab (with the concentration of 40mg/0.8ml) produced by Cinnagen Company (CinnoRA®) subcutaneously and as a single dose. Standard treatment: Oxygen therapy, using a mask or nasal cannula based on the patients' O2 saturation. Corticosteroids (if more than 5 days since the onset of symptoms have passed or SatO2 without adjuvant oxygen is below 90) are prescribed for a maximum of 2 weeks as following: Dexamethasone 6-8 mg/day or Prednisolone 0.5 mg/kg/day (max: 40mg). Anticoagulants, including heparin or enoxaparin: Subcutaneous enoxaparin in patients with GFR above 30:For BMI below 30=40mg/day subcutaneously, For BMI above 30=60mg/day subcutaneously or Heparin 5000U, TDS subcutaneously. Due to the lack of conclusive evidence for effectiveness of antiviral therapies in hospitalized patients with COVID-19, one of these antivirals including Lopinavir/Ritonavir, Atazanavir or Remdesivir may be prescribed based on physician’s decision. Control group: The control group receives standard treatment including the following: Oxygen therapy, using a mask or nasal cannula based on the patients' O2 saturation. Corticosteroids (if more than 5 days since the onset of symptoms have passed or SatO2 without adjuvant oxygen is below 90) are prescribed for a maximum of 2 weeks as following: Dexamethasone 6-8 mg/day or Prednisolone 0.5 mg/kg/day (max: 40mg). Anticoagulants, including heparin or enoxaparin: Subcutaneous enoxaparin in patients with GFR above 30:For BMI below 30= 40mg/day subcutaneously, For BMI above 30= 60mg/day subcutaneously or Heparin 5000U, TDS subcutaneously. Due to the lack of conclusive evidence for effectiveness of antiviral therapies in hospitalized patients with COVID-19, one of these antivirals including Lopinavir/Ritonavir, Atazanavir or Remdesivir may be prescribed based on physician’s decision. Mortality rate in day 28. Timepoint: From day 1 to day 28. Method of measurement: During the hospital stay based on the doctor's approval and then by phone call and taking a history in day 28. Changes in laboratory data. Timepoint: Day 1, day 3-5 and at the time of discharge. Method of measurement: Laboratory test. 2. Changes in SpO2. Timepoint: Day 1, day 3-5 and at the time of discharge. Method of measurement: Physical examination. Radiographic changes of the lungs. Timepoint: Day 1 and week 6. Method of measurement: CT-scan. Duration (days) of supplemental oxygenation. Timepoint: Day 1 to the time of discharge. Method of measurement: Clinical evaluation. Percent of patients with improvement in oxygenation (at least one step decrease in oxygenation supply). Timepoint: Day 1 to the time of discharge. Method of measurement: Clinical evaluation. Incidence of any adverse events (AEs) during the study. Timepoint: Day 1 to the time of discharge. Method of measurement: Clinical evaluation. Changes in findings related to physical examinations and vital signs. Timepoint: Day 1 to day 3-5 and at the time of discharge. Method of measurement: Clinical evaluation. Tehran University of Medical Sciences Approved 2020-04-05 Research Ethics Committee of Tehran University of Medical Sciences Sixth floor, Research Deputy of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulvard Tehran Tehran Iran (Islamic Republic of)