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IRCT20080901001165N64 IRCT 2021-05-21 Ministry of Defense, Department of Health Evaluation of efficacy and safety of Glurunic acid (G2013) in patients with COVID-19 Evaluation of efficacy and safety of Glurunic acid (G2013) in patients with COVID-19 2021-05-31 anticipated 180 Complete https://irct.ir/trial/56367 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention. 3 COVID-19. Intervention 1: Intervention group: Guluronic acid (G2013) capsule 500 mg, 2 capsules every 12 hours, after meal, for 4 weeks; in addition to routine treatment according to the latest national guideline. Intervention 2: Control group: routine treatment according to the latest national guideline. 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 The release schedule is not clear yet.
public Armita Mahdavi Goorabi
Sanaaye St., Shahid-Langari St., No-bonyad Sq., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 2293 7031 name@domain.com Shahid Dr. Chamran hospital scientific Yunes Panahi
Mollasadra St., Vanak
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8245 5393 Yunespanahi@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. The patient/Legal guardian has written consciously and freely consent to participate in the study; In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital; Moderate to severe COVID pneumonia 18 years 65 years Both Pregnancy Lactation The patient is present at another clinical trial at the same time. Severe renal impairment Severe hepatic impairment Severe cardiac impairment Uncontrolled diabetes Active infection Active cancer Coagulopathy Primary immunodeficiency syndrome Allergy to Glurunic acid U07.1 Covid-19 Treatment - Drugs Treatment - Drugs Intervention group: Guluronic acid (G2013) capsule 500 mg, 2 capsules every 12 hours, after meal, for 4 weeks; in addition to routine treatment according to the latest national guideline. Control group: routine treatment according to the latest national guideline. Need to receive ICU service rate (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12). Timepoint: Daily. Method of measurement: Clinical assessment. Mortality rate. Timepoint: 30 days after including the study. Method of measurement: Clinical assessment. Length of hospitalization. Timepoint: The first day and the end of hospitalization. Method of measurement: The hospital record review. Laboratory changes. Timepoint: Daily until discharge. Method of measurement: Blood sample, laboratory analysis. Fever. Timepoint: Daily until discharge. Method of measurement: Clinical assessment. Respiratory distress. Timepoint: Daily until discharge. Method of measurement: Clinical assessment. Oxygen saturation without receiving oxygen supplement. Timepoint: Daily until discharge. Method of measurement: Pulse-oxymetery device. Side effects. Timepoint: Daily during hospitalization, weekly after discharge. Method of measurement: During hospitalization by clinical evaluation, after discharge by telephone follow-up. Ministry of Defense, Department of Health Approved 2021-03-02 Ethics committee of Shahid Chamran Hospital Shahid Chamran hospital, Sanaaye St., Shahid Langari St., Nobonyad Sq., Pasdaran Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)