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IRCT20200611047727N3 IRCT 2021-01-03 Shahid Beheshti University of Medical Sciences Corton's effect in improving patients with covid-19 evaluation of efficacy and safety of low dose Corticosteroid with severe Pneumonia covid-19 2020-07-22 anticipated 60 Complete https://irct.ir/trial/49116 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: simple Unit of randomization : individual Tools used in randomization : table of random numbers Included patients, in a simple randomized evaluation using even and odd numbers, would got codes for each treatment group. In case of odd numbers, the patient would be enrolled in the group one to receive high flow oxygenation at the first stage and following a washout period, take noninvasive ventilation. On the other hand, patients gotten even numbers would receive noninvasive ventilation for the first stage. Then, after a washout period, high oxygen therapy would be prescribed, Blinding description: The examining physician will not know the type of intervention. Therefore, the study will be performed blindly. 3 covid _19. Intervention 1: Intervention group: In the intervention group, methylprednisolone succinate was treated with 0.75-1 mg / kg and after 5 days, due to the information in the questionnaire, the disease outcome was evaluated and if treatment is continued or discontinued, it is requested. . Intervention 2: Control group: The control group receives all common and standard treatments according to the physician, but does not receive corticosteroids. All indicators and evaluation criteria in this group are measured before and after treatment. Yes - There is a plan to make this available What will be shared: Clinical trial data will be published as an article When: Start access 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: Related scientific research Where to obtain: مرکز تحقیقات بیماری های مزمن تنفسی بیمارستان مسیح دانشوری تهران How to obtain: Provide the initial file of the approved research plan Comments:
public Maryam Mirenayat
Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 MirenayaT_M@yahoo.com Shahid Beheshti University of Medical Sciences scientific Atefeh Fakharian
Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 fakharian_2005@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Corton's effect in improving patients with covid-19 Definitive diagnosis based on Covid-19 test result At least 7 days have passed since the onset of symptoms and at least 5 days of antiviral treatment Oxygen saturation level less than 93 18 years no limit Both Patients who are unable to go for follow-up scans B34.2 Coronavirus infection, unspecified Treatment - Drugs Placebo Intervention group: In the intervention group, methylprednisolone succinate was treated with 0.75-1 mg / kg and after 5 days, due to the information in the questionnaire, the disease outcome was evaluated and if treatment is continued or discontinued, it is requested. . Control group: The control group receives all common and standard treatments according to the physician, but does not receive corticosteroids. All indicators and evaluation criteria in this group are measured before and after treatment. Radiological changes. Timepoint: Before the intervention and six weeks later. Method of measurement: Through CT scan of the lungs. Oxygen levels. Timepoint: Before the intervention and six weeks later. Method of measurement: pulse oximeter. Dyspnea. Timepoint: Before the intervention and six weeks later. Method of measurement: In this questionnaire, it is estimated based on MMRC. Disease severity. Timepoint: Before the intervention and six weeks later. Method of measurement: Based on the amount of oxygen and clinical symptoms and CT involvement. Shahid Beheshti University of Medical Sciences Approved 2020-04-22 Ethics committee of Shahidbeheshti University of Medical Sciences Masih Daneshvari Hospital, Darabad, Shahid Bahonar Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)