Evaluating the efficacy and safety of bromhexine in hospitalized COVID-19 patients

Evaluating the efficacy and safety of bromhexine as a treatment option for patients with COVID-19

Prospective clinical trial with parallel randomized control and treatment, double blinded groups, phase 2 trial on 100 patients. Block randomization will be done using online website (www.sealedenvelope.com/simple-randomiser/v1/lists).

Masih Daneshvari Hospital. How to do the study: 100 patients with COVID-19, using block randomization will be divided in to intervention and control group (placebo). This is a double blind study. In this study patient and physician will be blinded. For blinding, treatment and placebo group will be named group A and B, respectively.

Patients who are ≥18 years old at time of signing Informed Consent Form with laboratory (RT-PCR) confirmed infection with COVID-19 and lung involvement confirmed with chest imaging will be included in the study. Furthermore, patients who are hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio <300mgHg and it is ≤12 days since illness onset are included in the study. Study exclusion criteria is as follows: Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit), pregnant or breastfeeding, or positive pregnancy test, patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.

Patients allocated to treatment group were given 8 mg bromhexine tablet (Tolid Daroo), four times a day, orally for 28 days in conjugation with supporting treatment. Furthermore, patients in the control group received placebo (Tolid Daroo) plus supportive treatment according to national guidelines.

Time to Clinical Improvement (TTCI), need for invasive mechanical ventilation, and death.

We randomize patients at a 1:1 ratio to receive either oral Bromhexine or placebo. Participants will be enrolled by the local principle investigators at site. Consecutively patients will receive a trial number by the principal investigator. Before the trial commences, each trial number will be randomized to a treatment arm by computer (randomization will be done using online website www.sealedenvelope.com/simple-randomiser/v1/lists) The intervention assignment communicates to the principle investigators. The study is double blinded and the trial monitor throughout by the data monitoring committee. Trial recruitment stops after the target study population is reached and will close when all patients complete their follow-up.

In this double blind study, patients who received the drug or placebo and physician (researcher) are blinded to the study groups (drug or placebo). Similar labeling will be used for the drug and placebo and only the randomizer will be aware of the study groups.

All potential data can be shared after blinding

Six months after publishing the results

Researchers working in academic institutions

For research purposes and meta-analysis studies

Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran

Official letter to the researchers through Email (fzh.dastan@gmail.com).