COVID-19 trials registries data warehouse

http://en.irct.ir/trial/53165

Dr. M. Samiei

Samiei.moh@gmail.com

2020-12-31

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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 )

2

Tabriz University of Medical Sciences

18

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

400

Survival levels of CRP, LDH, Troponin, Ferritin NLR (Neutrophil to Lymphocyte Ratio) and D-Dimer ICU transfer rate Intubation and Mechanical Ventilation

Phase 3

[{"arm_notes": "", "treatment_id": 240, "treatment_name": "Bromhexine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]