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IRCT20100228003449N31 IRCT 2020-10-08 Tehran University of Medical Sciences Corticosteroids in COVID-19 Comparing efficacy and safety of different doses of dexamethasone in hospitalized patients with COVID-19 2020-09-26 anticipated 119 Complete https://irct.ir/trial/51163 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done according to the blocks randomization method. Regarding to the sample size, 3 patients will be include in each block. According to 3 different doses of A-B-C, six different combinations of ABC, ACB, BAC, BCA, CAB, CBA exist. SAS procedure PROC PLAN will be applied to generate the random numbers. For numbers 0-1/6, 1/6-2/6, 2/6-3/6, 3/6-4/6, 4/6- 5/6 and 5/6-6/6 following combinations ABC, ACB, BAC, BCA, CAB, CBA will be assigned respectively. 2-3 COVID-19 pneumonia. Intervention 1: Intervention group: Concomitant with the standard of care, patients in group 1 will receive dexamethasone 4 mg IV BD for 7-10-days. Patients will be daily followed for response to the therapy and adverse reactions. Intervention 2: Intervention group: Intervention group: Concomitant with the standard of care, patients in group 2 will receive dexamethasone 8 mg IV BD for 7-10-days. Patients will be daily followed for response to the therapy and adverse reactions. Intervention 3: Intervention group: Concomitant with the standard of care, patients in group 3 will receive dexamethasone 8 mg IV TDS or more for 7-10-days. Patients will be daily followed for response to the therapy and adverse reactions. Yes - There is a plan to make this available What will be shared: Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript When: One year after finishing the study, data will be published and will be available in databases To whom: After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes Conditions: Other researchers are permitted to included the results in their systematic reviews and metaanalysis Where to obtain: For this you may ask Hossein Khalili through following information: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave.,Tehran, Iran Postal code: 1417614411 E-mail: khalilih@tums.ac.ir How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks Comments:
public Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of MedicalSciences, 16 Azar Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4715 khalilih@tums.ac.ir Tehran University of Medical Sciences scientific Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4715 khalilih@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adult patients (18-85 years old) With diagnose of COVID-19 according to laboratory, clinical or radiological findings With indication for hospitalization 18 years 85 years Both Contraindication of corticosteroids (uncontrolled diabetes mellitus, active bacteria, fungal or parasite infections, hypersensitivity reactions, close angle glaucoma, uncontrolled neuropsychiatric disorders, unstable cardiovascular disorders including acute myocardial infarction, acute thrombosis, uncontrolled hypertension, viral hepatitis, history of corticosteroids induced myopathy) Pregnancy Lactation History of recent corticosteroids or other immunosuppressant drugs use U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Concomitant with the standard of care, patients in group 1 will receive dexamethasone 4 mg IV BD for 7-10-days. Patients will be daily followed for response to the therapy and adverse reactions. Intervention group: Intervention group: Concomitant with the standard of care, patients in group 2 will receive dexamethasone 8 mg IV BD for 7-10-days. Patients will be daily followed for response to the therapy and adverse reactions. Intervention group: Concomitant with the standard of care, patients in group 3 will receive dexamethasone 8 mg IV TDS or more for 7-10-days. Patients will be daily followed for response to the therapy and adverse reactions. Improvement of patients' chief complaint. Timepoint: Daily. Method of measurement: Clinical examination. Improvement in peripheral blood oxygen saturation. Timepoint: Daily. Method of measurement: Pulse oximetry. Decrease in serum CRP. Timepoint: Every other day. Method of measurement: Laboratory data. Hyperglycemia. Timepoint: Daily. Method of measurement: Glucometer. Changes in mood. Timepoint: Daily. Method of measurement: Psychiatric examination. Myopathy. Timepoint: Daily. Method of measurement: Physical examination. Secondary infections. Timepoint: Daily. Method of measurement: Clinical examination and laboratory parameters (CBC). Tehran University of Medical Sciences Approved 2020-09-09 Ethics Committee of Tehran University Of Medical Sciences Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)