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IRCT20210223050466N1 IRCT 2021-03-27 Shahre-kord University of Medical Sciences Comparison between dexamethasone and methylprednisolone in treatment of COVID-19 Comparison between intravenous dexamethasone and methylprednisolone in treatment of hospitalized patient with COVID-19 2021-03-21 anticipated 140 Complete https://irct.ir/trial/54662 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization of permutation blocks will be the volume of each block 6 and the randomization list will be prepared using random allocation software and will be provided to a person who has no information about the content of the groups, Blinding description: In this study patients don't know which group of them will use the ‎medicine. Physician and clinicians team know about the medicine and intervention groups.‎. 2-3 COVID-19 disease. Intervention 1: Intervention group 1: hospitalized patients with COVID-19 who take 60 mg intravenous Methylprednisolone in two divided dose, maximum 10 days in addition to standard treatment. Intervention 2: Intervention group 2: hospitalized patients with COVID-19 who take 8 mg intravenous Dexamethason daily maximum 10 days in addition to standard treatment. 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 No more data is available
public Marziyeh dehghani
Internal medicine group office, Hajar hospital, Parastar Ave.
Shahr-e-Kord Iran (Islamic Republic of) 8815854459 +98 38 3352 2940 marziehds@gmail.com Shahre-kord University of Medical Sciences scientific Zahra Habibi dastenaei
Internal medicine group office, Hajar hospital, Parastar Ave.
Shar-e-Kord Iran (Islamic Republic of) 8815854459 +98 38 3352 2940 habibi.z@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patient with COVID-19 Under 80 y/o age With positive RT-PCR test With bilateral lung parenchyma infiltration Blood oxygen saturation <93% Did not take any medication or hospitalization for COVID-19 Taking any Corticosteroid They have tendency to participate in this study 15 years 80 years Both Patient leave hospital before discharge Patient who expire in first 24 hour after admission Patient with myocardial infarction during hospitalization Patient with underlying disease who have contraindication of corticosteroid such as acute hepatitis, fungal infection All patient who disagree to continue the study U07.2, U07 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group 1: hospitalized patients with COVID-19 who take 60 mg intravenous Methylprednisolone in two divided dose, maximum 10 days in addition to standard treatment. Intervention group 2: hospitalized patients with COVID-19 who take 8 mg intravenous Dexamethason daily maximum 10 days in addition to standard treatment. Blood oxygen saturation. Timepoint: In admission. Method of measurement: pulse oxymeter. Duration of hospitalization. Timepoint: From admission to discharge. Method of measurement: Obsevation. Duration between onset of symptom to start of corticosteroid. Timepoint: Before admission to start of drug. Method of measurement: Patient history. Mortality rate after 28 day. Timepoint: From admission to 28 day later. Method of measurement: Observation. Number of oxygen dependency days. Timepoint: From admission to oxygen dependency time. Method of measurement: Observation. Number of patient who need ICU admission. Timepoint: During hospitalization. Method of measurement: Obsevation. Lab data. Timepoint: During admission , hospitalization and discharge. Method of measurement: Laboratory. Shahre-kord University of Medical Sciences Approved 2020-12-23 Ethics committe of Shahr-e-Kord University of Medical Sciences Shahr-e-Kord University of Medical Sciences, Kashani Blvd. Shar-e-kord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)