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IRCT20201015049030N1 IRCT 2020-11-07 Tehran University of Medical Sciences Effect of Dexamethasone on treatment of COVID-19 Study of Dexamethasone effects on the improvement of clinical symptoms and laboratory signs of Iranian COVID-19 patients: a clinical trial study 2020-09-11 anticipated 200 Complete https://irct.ir/trial/51736 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients to the intervention and control groups will be done based on the Permuted balanced block randomization method and according to the patients' file numbers, 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 COVID-19 disease. Intervention 1: Intervention group: 100 outpatients with Covid 19 with respiratory symptoms who in addition to their standard treatment will receive 8mg Dexamethasone (If patient's condition does not change, the dose will repeat after 48 hours). Intervention 2: Control group: 100 outpatients with Covid 19 with respiratory symptoms who are received 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 There is no more information
public Mohamadreza Salehi
Imam Khomeini Hospital Complex, Tohid Squre
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1594 salehi.mohamad3@gmail.com Tehran University of Medical Sciences scientific Mahdi Mahmoudi
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1416753955 +98 21 8822 0067 mahmoudim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Outpatients with Covid 19 confirmed by positive PCR test for SARS-CoV-2 or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities), With blood oxygen saturation between 90-95% Patients with severe respiratory symptoms such as cough, shortness of breath and severe shortness of breath or CRP above 20 or after three days of standard treatment worsened symptoms of the disease, including exacerbated fevers, aggravated weakness or aggravated shortness of breath based on the physician's clinical judgment 18 years no limit Both Patients with a history of underlying disease such as diabetes, malignancies, renal and heart failure, uncontrolled hypertension, and taking immunosuppressive drugs and corticosteroids Patients with other active infections Pregnant or lactating women U07.2, U07 COVID-19 Treatment - Drugs Treatment - Other Intervention group: 100 outpatients with Covid 19 with respiratory symptoms who in addition to their standard treatment will receive 8mg Dexamethasone (If patient's condition does not change, the dose will repeat after 48 hours). Control group: 100 outpatients with Covid 19 with respiratory symptoms who are received standard treatment O2 saturation. Timepoint: Before, one and two weeks after dexamethasone treatment. Method of measurement: Pulse Oximeter. Mortality rate. Timepoint: Before and after dexamethasone treatment. Method of measurement: Observation. Need for an oxygen therapy. Timepoint: Before and after dexamethasone treatment. Method of measurement: Clinical. Constitutional. Timepoint: Before, one and two weeks after dexamethasone treatment. Method of measurement: Clinical. Needs of hospitalization. Timepoint: Before and after treatment. Method of measurement: Observation. CRP laboratory test. Timepoint: Before, one and two weeks after dexamethasone treatment. Method of measurement: Para-clinical. CBC laboratory test. Timepoint: Before, one and two weeks after dexamethasone treatment. Method of measurement: Para-clinical. Tehran University of Medical Sciences Approved 2020-09-10 Vice-Chancellor in Research Affairs Tehran University of Medical Science Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)