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IRCT20200317046797N4 IRCT 2020-04-14 Tabriz University of Medical Sciences Effect of Bromhexine Hydrochloride on patients with COVID-19 Effect of Bromhexine Hydrochloride on clinical improvement and outcome of COVID-19-induced pneumonia 2020-04-18 anticipated 60 Complete https://irct.ir/trial/46969 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple randomization will be generated with a computer from 1 to 60. The computer will divide the digits between the two groups. According to the sequences of admission, they will go to the control or the intervention group regarding the computerized random list. 3 Condition 1: Patients with COVID-2019. Condition 2: . Intervention 1: Intervention group:30 patients with COVID-19 in addition to a standard regimen will receive Bromhexine 8 mg tablets every 8 hours for 14 days from the beginning of hospitalization. Intervention 2: Control group: 30 patients will receive only standard regimen of COVID-2019. 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 -
public Dr Khalil Ansarin
Daneshgah Street, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3335 2898 dr.ansarin@gmail.com Tabriz University of Medical Sciences scientific Mohammadreza Ardalan
Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 9331 ardalan34@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with COVID-19-induced pneumonia confirmed with PCR Patients or authorized family members volunteered to participate in this study and signed informed consent. Both genders 18 to 80 years old 18 years 80 years Both Patients who are participating in other drug clinical trials Pregnant or lactating women Patient with active thrombotic event Patients with severe respiratory failure U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group:30 patients with COVID-19 in addition to a standard regimen will receive Bromhexine 8 mg tablets every 8 hours for 14 days from the beginning of hospitalization Control group: 30 patients will receive only standard regimen of COVID-2019 Hospitalization days. Timepoint: At baseline and discharge time. Method of measurement: Counting the days. Need for mechanical ventilation. Timepoint: From baseline to discharge time. Method of measurement: Observation and documents. Condition of discharge (death or recovery). Timepoint: End of hospitalization. Method of measurement: Observation and documents. Period of mechanical ventilation. Timepoint: End of hospitalization. Method of measurement: Documents of hospitalization. Tabriz University of Medical Sciences Approved 2020-04-05 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)