]>
IRCT20200818048444N2 IRCT 2020-12-31 Tabriz University of Medical Sciences The Effect of Bromhexine Hydrochloride on Clinical Outcomes of Patients with COVID-19 disease BH8MGIRINT The Effect of Bromhexine Hydrochloride versus Placebo on Clinical Outcomes of Patients with COVID-19 disease: a Randomized Controlled Trial 2020-11-14 anticipated 400 Complete https://irct.ir/trial/53165 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1:1 randomization, centralized web-based randomization and according to the entry and exit criteria, through random allocation by balanced block method, individuals are divided into two groups of control and experimental. Using Random Sequence Generator, groups are created and people are placed in one of these two groups based on the reference sequence, Blinding description: This study is a two-way blind study. In this study, the subject and the researcher are both unaware of the drug used by individuals. The placebo and the main drug are placed in similar boxes with specific codes and are delivered to the patient by a third party. Medication information will not be visible to the therapist. 3 COVID19. Intervention 1: Intervention group: Bromhexine 8 mg every 8 hourly P O produced by Tolidaru. Intervention 2: Control group: Placebo as tablets that has been made similar to bromhexine and provided by the same drug company, Tolidaru, producing the bromhexine hydrochloride administered every 8 hourly p o for 16 days. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after unidentified the individuals. When: Second quarter of 2021 To whom: َAccess to data will be allowed for all researchers after submitting an access request and confirming it Conditions: In order to use the data, researchers must first identify and send the required items and data upon request, after which the data will be delivered. Where to obtain: By email dr.ansarin@gmail.com or postal code: 5142954481 How to obtain: The researcher must state his request in a letter. Upon agreeing to his request, the data will be emailed to him in Excel or Spss. Comments:
public Khalil Ansarin
Daneshghah Avenue, Pashmineh Building, Tuberculosis and Lung Disease Research Center
Tabriz Iran (Islamic Republic of) 5142954481 +98 41 3337 8093 dr.ansarin@gmail.com Tabriz University of Medical Sciences scientific Khalil Ansarin
Daneshghah Ave, Pashmineh Building, Tuberculosis and Lung Disease Research Center
Tabriz Iran (Islamic Republic of) 5142954481 +98 41 3337 8093 Dr.ansarin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) I-New laboratory confirmed diagnosis of SARS-CoV-2 via reverse transcriptase polymerase chain reaction as per the World Health Organization protocol, by nucleic acid based isothermal amplification, or by antigen testing OR II- Clinical suspicion of COVID-19 disease and acute onset (less than 10 days) and of AT LEAST ONE of the following conditions:• Loss of smell or taste• Cough or shortness of breath / dyspnea• Fever (body temperature > 38.5°)• PLUS Findings on chest-X ray or computer tomography suggestive of COVID-19 OR III- Clinical suspicion of COVID-19 disease and acute onset (less than 10 days) of AT LEAST TWO of the following conditions: • Chills or rigor • Conjunctivitis • Sore throat • Gastrointestinal symptoms • Headaches • Fatigue or malaise • Aches or pain PLUS Findings on chest-X ray or computer tomography suggestive of COVID-19 18 years and older Informed consent from the patient (or legally authorized substitute decision maker). 18 years no limit Both The exclusion criteria are: 1) Admitted to the intensive care unit at the time of screening; 2) Imminent initiation or treatment with invasive mechanical ventilation at the time of screening; 3) Imminent death according to the judgement of the most responsible physician; 4) Receiving palliative care; 5) Known history of severe liver or kidney dysfunction; 6) On treatment with Bromhexine hydrochloride at the time of screening; 7) Known allergy to bromhexine hydrochloride; 8) Pregnancy or breastfeeding (including baby to breast, bottle feeding mother's expressed breast milk); 9) Previous enrollment in this trial (Enrollment in another clinical trial does not preclude enrollment in this trial ) U07.1 COVID19 Treatment - Drugs Placebo Intervention group: Bromhexine 8 mg every 8 hourly P O produced by Tolidaru. Control group: Placebo as tablets that has been made similar to bromhexine and provided by the same drug company, Tolidaru, producing the bromhexine hydrochloride administered every 8 hourly p o for 16 days Survival. Timepoint: 28 days after start of the treatment. Method of measurement: Follow up from hospital files and phone F/U in subjects who discharged earlier. Levels of CRP, LDH, Troponin, Ferritin. Timepoint: Day 1 and 28 days after treatment. Method of measurement: Standard laboratory hematology and biochemistry tests. NLR (Neutrophil to Lymphocyte Ratio) and D-Dimer. Timepoint: Day 1 and 28 days after treatment. Method of measurement: Standard laboratory hematology and biochemistry tests. ICU transfer rate. Timepoint: 28 days after start of the treatment. Method of measurement: Follow up from hospital files and phone F/U in subjects who discharged earlier. Intubation and Mechanical Ventilation. Timepoint: 28 days after start of the treatment. Method of measurement: Follow up from hospital files and phone F/U in subjects who discharged earlier. Health Vice-Chancellor of Ministry of Health and Medical Education (MOHME) Approved 2020-12-21 Regional Committee for Research Ethics(Human Subject Studies(91000001)) Third Floor / Tabriz University of Medical Sciences, Central Building No. 2/Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)