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IRCT20080901001165N53 IRCT 2020-05-14 Bagheiat-allah University of Medical Sciences Investigating the efficacy and safety of Interferon Beta1a nasal spray in controlling the symptoms of patients with COVID-19 Investigating the efficacy and safety of Interferon Beta1a nasal spray in controlling the symptoms of patients with COVID-19 2020-05-14 anticipated 100 Complete https://irct.ir/trial/48066 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomized the patients. In this method, the number of people assigned to each group is usually almost equal. Blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as witnesses. The main goal in this method is to balance the number of participants in each group. 3 COVID-19. Intervention 1: Intervention group: Interferon Beta 1a nasal spray 1 puff in each nostril every 6 hours, for 14 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 Seyed Hasan Saadat
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 saadat350@gmail.com Bagheiat-allah 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: equal or more than 18 years; The patient have written consciously and freely consent to participate in the study; The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms. 18 years no limit Both History of allergy to this nasal spray ingredients; Hypersensitivity reaction while taking this nasal spray; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the intensive care unit; Pregnancy; Lactation. Chronic kidney disease, stage 3 to 5; Receiving ACEI/ARB group; U07.1 Covid-19 Treatment - Drugs Treatment - Drugs Intervention group: Interferon Beta 1a nasal spray 1 puff in each nostril every 6 hours, for 14 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. Clinical 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. Clinical 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. Clinical 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. 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. Side effects. Timepoint: Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist. Method of measurement: Physical examination. Mortality. Timepoint: Day 14 from the initiation. Method of measurement: Clinical assessment. Cinnagen company Bagheiat-allah University of Medical Sciences Baqiyatallah University of Medical Science Approved 2013-05-03 Ethics committee of Baqiyatallah University of Medical Science Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)