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IRCT20190312043030N2 IRCT 2020-08-19 Tabriz University of Medical Sciences The effect of selenium, vitamin C and methylprednisolone combination on mortality and morbidity of Covid-19 patients. covid-19 The effect of combination of selenium, vitamin C and methylprednisolone in acute respiratory distress syndrome mortality and morbidity from COVID-19 2020-06-29 anticipated 40 Complete https://irct.ir/trial/49508 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 10 units of 4 blocks will be selected so that we consider having 20 people in control group (A) and 20 people in intervention group (B). Therefore, we will do block randomization, Blinding description: In this study, clinical caregivers, outcome assessor and data analyzer will not know about grouping. Outcome assessor and data analyst are blind in this study thus the findings are related to groups A and B in the study. 3 COVID-19. Intervention 1: Control group:This group undergoing only routine treatments of the intensive care unit will be provided according to the national protocol that include tablet hydroxychloroquine and tablet lupinavir/ritonavir for 14 days and supportive care in ICU. Intervention 2: Intervention group: This group underwent routine treatments in the intensive care unit according to the national protocol for Covid 19 patients plus cocktail therapy of 1 mg daily intravenous selenium, 60 mg / kg / d vitamin C and 1 mg / kg / d one hour infusion of methylprednisolone for 7 days. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable. When: Starting 6 months after publication To whom: Documents will be available for people working in academic institutions and also people working in businesses. Conditions: There will be no specific limitations to the utilization of the data Where to obtain: Dr .Seyed Hadi Saghaleini Sina Hospital Azadi Street, Sina Hospital, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 41 35412101 Fax+98 41 35412101 hsaghaleini@gmail.com How to obtain: Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Dr.Seied Hadi Saghaleini
Sina Hospital , Azadi street ,Tabriz
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 3541 2101 hsaghaleini@gmail.com Tabriz University of Medical Sciences scientific Dr.Seied Hadi Saghaleini
Sina Hospital , Azadi street ,Tabriz
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 3541 2101 hsaghaleini@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Positive PCR test for Covid 19 Diffuse asymmetric pulmonary involvement on CT scan complies with Covid-19 Absence of evidence of liquid overload. PaO2/FiO2 ratio ≤300 and >200 is mild ARDS; PaO2/FiO2 ratio100-200 is moderate ARDS; PaO2/FiO2 ratio <100 is severe ARDS new/worsening respiratory symptoms within 1 week 18 years 90 years Both Corticosteroid history over the past 3 months Sensitivity to vitamin C. Increased sensitivity to selenium. Primary creatinine above 1.5. Ethylene glycol poisoning. U07.1 COVID-19 Prevention Prevention Control group:This group undergoing only routine treatments of the intensive care unit will be provided according to the national protocol that include tablet hydroxychloroquine and tablet lupinavir/ritonavir for 14 days and supportive care in ICU Intervention group: This group underwent routine treatments in the intensive care unit according to the national protocol for Covid 19 patients plus cocktail therapy of 1 mg daily intravenous selenium, 60 mg / kg / d vitamin C and 1 mg / kg / d one hour infusion of methylprednisolone for 7 days Days of hospitalization in ICU. Timepoint: From the time of the patient's arrival until the diagnosis of ICU. Method of measurement: According to the number of days the patient was hospitalized in the ICU. Mortality. Timepoint: From the beginning of the interventions to 5 days after the end of the interventions. Method of measurement: Mortality census based on patients recorded information. Duration of mechanical ventilation. Timepoint: From the time the patient enters the ICU until discharge from this ward. Method of measurement: Number of days the patient is under mechanical ventilation based on patients recorded information. Days of hospitalization. Timepoint: From initial admission to hospital discharge. Method of measurement: Number of days of patient attendance from initial admission to hospital discharge based on patients recorded information. Tabriz University of Medical Sciences Approved 2020-06-29 Ethic Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)