COVID19. COVID19
Conditions
Interventions
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
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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 )
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKhalil Ansarin
Tabriz University of Medical Sciences
Outcome results
None listed