Verification of the efficacy of bromhexine hydrochloride in the prevention of COVID-19 disease

The efficacy of bromhexine hydrochloride in the prevention of COVID-19 disease will be studied.

A clinical trial with a control group, with parallel groups, simple-randomly assigned to intervention and control groups, Phase 2, 3500 close contacts of patients with COVID-19 disease

This study will be performed in Imam Reza Hospital in Tabriz, Iran. 3500 contacts of patients with COVID-19 will be selected and randomly divided into two groups. The control group will receive a placebo and the intervention group will receive 8 mg bromhexine tablets every 8 hours for 14 days. Lung CT scan, Coronavirus PCR test, and IgM and IgG levels will be checked.

Inclusion criteria: 18 to 80 years old; both genders; having household contact, having contact with a COVID-19 case without a facemask that is confirmed with RT-PCR or with clinical or radiographic evidence of pneumonia, and acute respiratory distress syndrome (ARDS); lack of the clinical symptoms of COVID-19 (fever, cough, dyspnea, having difficulty in breathing, sore throat, severe fatigue, GI symptoms); lack of chronic respiratory or other illnesses with symptoms that are mostly confused with symptoms of COVID-19 disease. Exclusion criteria: less than 18 years old; severe renal failure; severe liver disease; pregnancy, breastfeeding, or a positive pregnancy test result; subjects who receive immune-modulating drugs for other diseases; participants in other clinical trials for COVID-19 within 30 days before or after randomization; participants in other drugs clinical trial; having an allergy to bromhexine hydrochloride or its ingredients

The intervention group will receive 8 mg bromhexine tablets every 8 hours for 14 days.

Lung CT scan, coronavirus PCR test, and biochemical, immunological, and clinical tests

Based on the inclusion and exclusion criteria, the subjects will be randomized into two (control and experimental) groups via balanced block randomization. The groups will be generated by a computer-based random sequence generator and individuals will enter the assigned groups based on their entry sequence.

This is a double-blind study in which both researchers and contacts will not be aware of the individuals' drug administration. Placebo and the main drug will be dispensed by a third person in uniform packages with defined codes. Instructions on the drug consumption will not be seen by the prescriber.