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IRCT20120703010178N22 IRCT 2020-12-07 Shahid Beheshti University of Medical Sciences Bromhexine hydrochloride for prophylaxis against COVID-19 A Randomized, Multi-centric, Double-blind, Placebo-controlled study to Evaluate the Efficacy and Safety of Bromhexine, a serine protease (TMPRSS2) blocker, to prevent COVID-19 2020-08-22 anticipated 1050 Complete https://irct.ir/trial/49850 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: In this clinical trial an interim analysis in the sample size if 50% is allowed, Randomization description: Randomization will be recorded on an Excel file by the principal investigator. Participants will be randomized via permuted block randomization. Each block will be consistent of variable sizes of 4 or 6 or 8 patients. For assignment of each patient to the drug or placebo group, for each patients a unique code consistent of 2 letters and a digit will be assigned. the code will be unique for each patient ( for example code AB1 for first patient). Only the principle investigator will be informed of the assignment of each code to the medication or placebo group, Blinding description: Participants will be provided masked study medicine, directly in research centers or shipped by courier service. The intervention vs. placebo will not be identical; however, participants and outcome assessors will be masked to their assignment. 3 Condition 1: COVID-19. Condition 2: COVID-19. Intervention 1: Intervention group: Receiving Bromhexine 8 mg 3 times a day for 14 days in patients with history of close contact to confirmed COVID-19 in past 4 days. Intervention 2: Control group: Receiving placebo 3 times a day for 14 days in patients with history of close contact to confirmed COVID-19 in past 4 days. Yes - There is a plan to make this available What will be shared: Primary and secondary outcome data after making participants unrecognizable will be released When: 6 months after publishing the results of primary outcome To whom: Any researchers will have access to the data after allowance of corresponding author Conditions: Performing any analysis to any data resulted form this study will be allowed only with the permission of corresponding author Where to obtain: Correspondance author How to obtain: After requesting for data, correspondence will check the authorization and then they will be informed about it Comments:
public Mohammad Sistanizad
Department of Clinical Pharmacy, Shahid Beheshti School of Pharmacy, after Niayesh intersection; Valiasr street
Tehran Iran (Islamic Republic of) 6153- 14155 +98 218800087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Department of Clinical Pharmacy, Shahid Beheshti School of Pharmacy, after Niayesh intersection; Valiasr street
Tehran Iran (Islamic Republic of) 6153- 14155 +98 218800087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Exposure and close contact (defined as being within 6 feet for a period of 15 minutes or more in a 24 hour period or 5 minutes or more for healthcare associated exposure) to a COVID-19 case within 4 days before entering the study must agree not to enroll in another investigational study prior to completion of Day 14 of study Individuals who have the ability to understand and desire to sign the informed consent Age of 18 years or more 18 years no limit Both Current Hospitalization Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation Hypersensitivity to bromhexine or any component of the formulation Low risk in individuals in close contact (wearing face mask and eye shield) Individuals with exposure of less than 15 minutes Receipt of any medication for prophylaxis and treatment of 2019-nCoV Patients with any related sign and symptoms of COVID-19 U07.1 U07.2 COVID-19, virus identified COVID-19, virus not identified Treatment - Drugs Placebo Intervention group: Receiving Bromhexine 8 mg 3 times a day for 14 days in patients with history of close contact to confirmed COVID-19 in past 4 days Control group: Receiving placebo 3 times a day for 14 days in patients with history of close contact to confirmed COVID-19 in past 4 days Incidence of COVID-19 disease. Timepoint: At day 14. Method of measurement: Clinical assessment. Ordinal Scale of COVID-19 disease severity. Timepoint: Censored at Day 14. Method of measurement: Clinical assessment. Hospitalization or death. Timepoint: Day 14. Method of measurement: Phone call. Confirmed COVID-19 diagnosis. Timepoint: Day 14. Method of measurement: Self report. Sign and Symptoms compatible with COVID-19. Timepoint: day 14. Method of measurement: Self report. Treatment withdrawal or discontinuation. Timepoint: day 14. Method of measurement: self report. Shahid Beheshti University of Medical Sciences Approved 2020-11-01 Ethics committee of School of Pharmacy and Nursing & Midwifery; Shahid Beheshti University of Medica Niayesh complex; No 2660; Valiasr street; Tehran Tehran Tehran Iran (Islamic Republic of)