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IRCT20200204046369N1 IRCT 2020-04-08 Shiraz University of Medical Sciences Effect of Methylprednisolone in treatment of COVID-19 patients Evaluation of Methylprednisolone Administration as a Therapeutic Option in the Coronavirus disease 2019 (COVID-19): A Randomized Controlled Study 2020-08-07 anticipated 82 Complete https://irct.ir/trial/46776 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation using the block randomization method was performed in all four branches of the strata, based on two prognostic factors such as age (< 55 and ≥55) and disease severity based on O2 Saturation (<85 and ≥85). During random allocation, allocation concealment was noticed. The patient, assessor, and analyzer in the two groups did not have access to the randomization list and type of administered drug (Triple blind), Blinding description: Packaging containers contain unnamed medicine and there is only one registration number on them in the research center and this number is also available to the treating physicians. Thus, none of the patients, colleagues who are in charge of clinical follow-up and outcome assessment, and those who perform statistical analysis of study data, before the allocation concealment and after the study (blinding), will not know the patient's group therapy. 2-3 the 2019 novel Corona virus (COVID-19). Intervention 1: Intervention group: In addition to the standard care recommended by the National Committee, an initial dose of 2mg/kg will be started for all patients in the case group. The patients will receive the mentioned dose for 5 days, which will then be halved every 5 days. Intervention 2: Control group: Patients, in addition to the standard care recommended by the National Committee, receive dexamethasone 6 mg daily intravenously. Yes - There is a plan to make this available What will be shared: The study results will be published as an article. The study protocol and statistical analysis used in the article will be considered. When: It will be published a year after the study is completed and will be available in the sources. To whom: Information will be made available after permission of the sponsor for academic researchers, physicians, and academic institutions . Conditions: Other researchers can use the results of the study in their review and meta-analysis. Where to obtain: Dr Moghadami, Department of Internal Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran How to obtain: upon request, the corresponding author will respond after consulting with the sponsor of the study. Comments:
public Dr. Mohsen Moghadami
Zand street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 moghadami@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Mohsen Moghadami
Zand street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 moghadami@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) RT-PCR documented SARS-CoV-2 carriage in a nasopharyngeal and oropharyngeal sample at admission Age over 18 years old O2 saturation of less than 92 in room air Hospitalized patients 18 years no limit Both A known contraindication to treatment with the steroid Breastfeeding and pregnant patients Uncontrolled diabetes mellitus Uncontrolled hypertension patients who had previously been treated with steroids for any reason O2 Saturation of above 92 in room air Dissatisfaction with the study enrollment Immunodeficiency disorders U07.1 COVID-19 confirmed by laboratory testing. Treatment - Drugs Treatment - Drugs Intervention group: In addition to the standard care recommended by the National Committee, an initial dose of 2mg/kg will be started for all patients in the case group. The patients will receive the mentioned dose for 5 days, which will then be halved every 5 days. Control group: Patients, in addition to the standard care recommended by the National Committee, receive dexamethasone 6 mg daily intravenously. The all-cause mortality in 28 days. Timepoint: 28 days. Method of measurement: Clinical follow-up. Clinical status. Timepoint: 5 and 10 days after intervention. Method of measurement: 9-points WHO ordinal scale. Intubation and need for ventilation, and also admission to ICU. Timepoint: 5 and 10 days after intervention. Method of measurement: Clinical follow-up. Duration of hospital admission. Timepoint: 5 and 10 days after intervention. Method of measurement: Clinical follow-up. Shiraz University of Medical Sciences Approved 2020-04-04 Ethics committee of Shiraz University of Medical Sciences zand street Shiraz Fars Iran (Islamic Republic of)