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IRCT20080901001165N46 IRCT 2020-04-15 Center for Progress and Development of Iran Investigating the efficacy and safety of Umifenovir in controlling the symptoms of patients with COVID-19 Investigating the efficacy and safety of Umifenovir in controlling the symptoms of patients with COVID-19 2020-03-30 anticipated 200 Complete https://irct.ir/trial/47087 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomized the patients. 3 COVID-19. Intervention 1: Intervention group: Capsule Umnifenovir 100 mg, 2 capsuls every 6 hours, for 7 days. (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus. 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 data release schedule is still unclear.
public Parisa Kianpour
Pharmacy faculty, Tehran university of medical science, 16 Azar St., Enghelab Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4709 parisa_kianpour@yahoo.com Tehran University of Medical Sciences scientific Yunes Panahi
Baqiyatallah university of medical science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8245 5393 Yunespanahi@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) age >18 years The patient have written consciously and freely consent to participate in the study. Confirmed diagnosis of COVID-19, with Laboratory (RT-PCR) confirmation. Confirmed diagnosis of COVID-19, with lung CT-Scan result, which is typical for COVID-19 pulmonary involvement. O2 saturation at rest in ambient air ≤93% 18 years no limit Both Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2. Participation in any other clinical trial of an experimental treatment for COVID-19 Pregnant or breastfeeding; Hypersensitivity reaction history with Umifenovir. patient with critical stage of disease (respiratory failure, sock, multi organ dysfunction) patient with at least one of these disease as past medical history: congenital heart disease, Congestive heart failure, coronary artery disease, severe heart rhythm disorders, serious neurological disease including stroke, epilepsy, mental retardation, spinal cord injury. Patients with immunodeficiency, including malignancies, HIV, organ transplants, receiving immunosuppressive drugs in the last previous 3 months. U07.1 Covid-19 Treatment - Drugs Treatment - Drugs Intervention group: Capsule Umnifenovir 100 mg, 2 capsuls every 6 hours, for 7 days. (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus) Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus Respiratory symptoms (dry cough). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire. Respiratory symptoms (respiratory distress). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: pulse oxymetery device. Respiratory symptoms (fever). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Thermometer. Radiologic finding changes in Lung CT-scan. Timepoint: before the intervention initiation (baseline), then at day 14. Method of measurement: Lung CT-scan. Lab tests changes. Timepoint: daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist. Method of measurement: blood sample, laboratory analysis. Mortality rate. Timepoint: day 14 of intervention initiation. Method of measurement: questionnaire. Adverse Effects. Timepoint: daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist. Method of measurement: questionnaire, clinical examination. Inflammatory biomarker level changes (including interleukin 1, interleukin 6, TNF alpha). Timepoint: before the intervention initiation (baseline), then at day 7. Method of measurement: Elisa kit for Human. Center for Progress and Development of Iran Approved 2020-03-29 Ethics committee of Baqiyatallah University of Medical Sciences Baqyiatallah University of Medical Science, south Shekhi-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)