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IRCT20200608047686N1 IRCT 2020-06-30 Shahid Beheshti University of Medical Sciences The role of metronidazole in COVID-19 Evaluation of therapeutic effects of Metronidazole In Inpatients with Pneuomonia Due to COVID-19 2020-05-31 anticipated 30 Complete https://irct.ir/trial/48717 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: According to the admission date of hospitalized patients with pneumonia due to COVID-19, Participants are randomly assigned to intervention or control groups and they are not aware of the group to which they are allocated.The "intervention group" receives national standard treatment in addition to metronidazole, and the "control group" receives standard treatment, Randomization description: simple randomization, Blinding description: After signing the consent form, According to the admission date of hospitalized patients with pneumonia due to COVID-19, Participants are randomly assigned to intervention or control groups and they are not aware of the group to which they are allocated. 2 COVID-19. Intervention 1: Intervention group: 15 eligible patients with moderate to severe COVID-19 in a 1:1 ratio compared to the control group who receive 250 mg metronidazole tablets orally every 6 hours for 7 days in addition to the standard treatment. Intervention 2: Control group: 15 eligible patients with moderate to severe COVID-19 disease who receive national standard treatment for COVID-19. Yes - There is a plan to make this available What will be shared: At the time of publication When: At the time of publication To whom: Public Conditions: They will be publically available. Where to obtain: The study protocol, statistical analytic plan informed consent forms will be shared as supplementary material at the time of publication of results. How to obtain: The study protocol, statistical analytic plan informed consent forms will be shared as supplementary material at the time of publication of results. Comments:
public Muhanna Kazempour
Loghman Hakim Hospital, Kamali Ave, South Kargar St
Tehran Iran (Islamic Republic of) 1333625445 +98 21 5541 9005 muhannakazempour@gmail.com Shahid Beheshti University of Medical Sciences scientific Muhanna Kazempour
Loghman Hakim Hospital, Kamali Street, South Karegar Avenue
Tehran Iran (Islamic Republic of) 1333625445 +98 21 5541 7243 muhannakazempour@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inpatients with Pneuomonia Due to COVID-19 18 years no limit Both Hypersensitivity Reactions to Metronidazole Pregnancy U07.1 COVID-19 Treatment - Drugs N/A Intervention group: 15 eligible patients with moderate to severe COVID-19 in a 1:1 ratio compared to the control group who receive 250 mg metronidazole tablets orally every 6 hours for 7 days in addition to the standard treatment. Control group: 15 eligible patients with moderate to severe COVID-19 disease who receive national standard treatment for COVID-19. O2 Saturation. Timepoint: within 7 days from initiation of study treatmentat. Method of measurement: Pulse Oximetry. Lenght of hospitat stay. Timepoint: daily up to discharge. Method of measurement: Inpatient days. Mortality. Timepoint: daily up to death during hospitalizatiion. Method of measurement: Patient death. Shahid Beheshti University of Medical Sciences Approved 2020-05-30 Ethics committee of Shahid beheshti University of Medical Sciences Yaman St, Velenjak, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)