The effect of the bromhexine-hydrochloride plus hydroxychloroquine on outcome of patients with COVID-19: A randomized, triple-blind, placebo-controlled trial

Tabriz University of Medical Sciences0 个研究点目标入组 800 人开始时间: 待定最近更新: 2022年1月11日

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•COVID19 diagnosis by a physician on the basis of history and physical examination and compatible imaging and PCR testing as:
•1, Having symptoms of COVID19 disease: FEVER (measured or subjective), COUGH, DYSPNEA, DIFFICULTY BREATHING, SORE THROAT, NEW OLFACTORY OR TASTE DISORDERS, SEVERE LASSITUDE OR FATIGUE, MYALGIAS, HEADACH, GI SYMPTOMS plus having compatible imaging or positive PCR testing for SARS virus COVID19 2, Being free of chronic respiratory or other illnesses with symptoms confused with symptoms of COVID19 disease AND 3 , Signed consent form.

•Major Exclusion Criteria: --1-1- Age: less than 18 years; justification: adult hospital with not enough young patients to compare and follow up 2- Pregnant or breast feeding woman: for fetal safety 3- Severe liver disease and severe renal failure: being confounding - 4- Serious eye disease with visual loss or cardiac conduction defects: as a confounder in side effects of drugs. 5- Subjects on immune modulating drugs for other diseases for: as confounding 6- Subjects already on bromhexine hydrochloride or hydroxychloroquine. 7- Subjects with history of allergy to bromhexine hydrochloride or hydroxychloroquine. 8- Subjects in other clinical trials for COVID-19 within 30 days before or after this trial: for being confounding. 9- Direct admission of patient to ICU at the the time of screening: because of the conflict with one of outcomes. 10- Having other subject characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, severe renal failure, malignancies, and etc.) that may impact primary and other clinical endpoints. 11-Impending death at the time of admission on the judgement of physician. 12- Other uncontrolled disease, as judged by investigators influencing study endpoints.

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