Verification of the efficacy of Bromhexine-hydrochloride in treatment of patients with COVID19 disease

Phase 3

Conditions: COVID-19.
COVID-19
U07.1

Registration Number: IRCT20200818048444N1

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 1300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures