The Effect of Bromhexine Hydrochloride versus Placebo on Clinical Outcomes of Patients with COVID-19 disease: a Randomized Controlled Trial

Tabriz University of Medical Sciences0 个研究点目标入组 400 人开始时间: 待定最近更新: 2021年1月5日

试验速览

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•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 )

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