The Effect of Bromhexine Hydrochloride on Clinical Outcomes of Patients with COVID-19 disease
- Conditions
- COVID19.COVID19U07.1
- Registration Number
- IRCT20200818048444N2
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
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).
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 )
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method