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IRCT20200818048444N1 IRCT 2020-09-15 Tabriz University of Medical Sciences Verification of the efficacy of Bromhexine-hydrochloride in treatment of patients with COVID19 disease COV-19 Verification of the efficacy of Bromhexine-hydrochloride in treatment of patients with COVID19 disease 2020-09-22 anticipated 1300 Complete https://irct.ir/trial/50780 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the entry and exit criteria, through random allocation by variable 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 COVID-19. Intervention 1: Intervention group: The intervention group will receive 8 mg bromhexine tablets every 8 hours for 14 days. Intervention 2: Control group: will receive 3 placebo tablets per day for 14 days. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after unidentified individuals. When: Spring 1400 To whom: Data is 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. After agreeing to his request, the data will be emailed to him in Excel or Spss. Comments:
public Khalil Ansarin
Tuberculosis and Lung Diseases Research Center, Pashmineh Building, University St.
Tabriz Iran (Islamic Republic of) 5142954481 +98 41 3337 8093 dr.ansarin@gmail.com Tabriz University of Medical Sciences scientific Khalil ansarin
Tuberculosis and Lung Diseases Research Center, Pashmineh Building, University St.
Tabriz Iran (Islamic Republic of) 5142954481 +98 41 3337 8093 dr.ansarin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 18 years and older, both sexes Having home contact, unmasked contact with a patient with Covid-19 confirmed by RT-PCR or clinical evidence or radiography of pneumonia and acute respiratory distress syndrome (ARDS); No clinical signs of Covid-19 (fever, cough, dyspnea, shortness of breath, sore throat, extreme tiredness, digestive problems); No chronic respiratory problems or other illnesses that are mistaken for symptoms of COVID-19 18 years no limit Both Involvement with any other ongoing studies. Pregnant or breast feeding woman or with positive pregnancy test result for fetal safety Severe liver disease as a strong confounding factor Severe renal failure as a strong confounding factor Refusal by attending physician for no clinical equipoise Advanced active malignancy as a strong confounding factor Patient in other clinical trials for COVID-19 within 30 days before/after ICF as a confounding factor/s Other patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, severe renal failure, and etc. May impact primary and other clinical endpoints- Known allergy to study drug or its ingredients related to renin-angiotensin system (RAS), or frequent and/or severe allergic reactions with multiple medications for patient protection purposes Other uncontrolled disease, as judged by investigators that may influence study endpoint and other clinical outcome U07.1 COVID-19 Prevention Placebo Intervention group: The intervention group will receive 8 mg bromhexine tablets every 8 hours for 14 days. Control group: will receive 3 placebo tablets per day for 14 days. Test for the presence or absence of nucleic acid in the corona virus. Timepoint: 15 days after the intervention. Method of measurement: real-time PCR. Serum IgM and IgG levels. Timepoint: 15 days after the intervention. Method of measurement: Immunology test. Ministry of Health and Medical Education Approved 2020-08-24 Regional Committee on Research Ethics (Studies in Human Subjects) Third Floor / Tabriz University of Medical Sciences, Central Building No. 2/Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)