Bromhexine for Post-exposure COVID-19 Prophylaxis: A Randomized, Double-blind, Placebo-controlled Trial

AuthorRamin Tolouianen
AuthorOmid Moradien
AuthorZuber D. Mullaen
AuthorShadi Ziaieen
AuthorMehrdad Haghighien
AuthorHadi Esmailyen
AuthorHossein Aminien
AuthorRezvan Hassanpouren
AuthorElham Poorheidaren
AuthorMehran Koucheken
AuthorAlireza Manafi-Rasien
AuthorShahnaz Salien
AuthorSara Abolghasemien
AuthorShabnam Tehranien
AuthorAudrey C. Tolouianen
AuthorAlireza Zalien
AuthorMohammad Sistanizaden
OrcidRamin Tolouian [0000-0003-2242-9310]en
OrcidOmid Moradi [0000-0001-5754-535X]en
OrcidZuber D. Mulla [0000-0003-1670-5702]en
OrcidShadi Ziaie [0000-0002-4358-470X]en
OrcidMehrdad Haghighi [0000-0003-3139-3225]en
OrcidHadi Esmaily [0000-0001-6915-6028]en
OrcidHossein Amini [0000-0002-6594-0760]en
OrcidRezvan Hassanpour [0000-0003-0165-4439]en
OrcidElham Poorheidar [0000-0001-5410-5068]en
OrcidMehran Kouchek [0000-0002-2070-9856]en
OrcidAlireza Manafi-Rasi [0000-0001-6355-704X]en
OrcidShahnaz Sali [0000-0001-8494-0611]en
OrcidSara Abolghasemi [0000-0001-7117-6079]en
OrcidShabnam Tehrani [0000-0001-7005-5398]en
OrcidAudrey C. Tolouian [0000-0002-9764-8510]en
OrcidAlireza Zali [0000-0002-2298-2290]en
OrcidMohammad Sistanizad [0000-0002-7836-6411]en
Issued Date2022-08-31en
AbstractBackground: Limited medications are available for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) infection. Whether bromhexine can prevent or mitigate symptomatic infection after virus exposure is undetermined. Objectives: We aimed to evaluate bromhexine's effect on preventing COVID-19 after close contact exposure. Methods: A multi-center randomized, double-blind, placebo-controlled clinical trial was conducted on 372 adults (≥ 18 years) who had close contact within four days with a household member with confirmed COVID-19. They were randomly assigned to receive bromhexine 8 mg (n = 187) or placebo (n = 185) three times a day for two weeks. The primary outcome was the incidence of symptomatic COVID-19. Secondary outcomes included hospitalization or death, confirmed COVID-19 by Polymerase Chain Reaction (PCR) in symptomatic patients, and adverse drug reactions. Results: The incidence of symptomatic COVID-19 was significantly lower in individuals who received bromhexine than in those who received the placebo (16 [8.6%] vs. 34 [18.4%], relative risk = 0.47, P = 0.005). PCR confirmation was reported in 13 (7.0%) and 26 (14.1%) individuals in the bromhexine and placebo groups, respectively (P = 0.025), with a relative risk reduction of 50%. The hospitalization rate, death, and medication side effects did not vary significantly between the bromhexine and placebo arms. Conclusions: Bromhexine is an effective, non-invasive, affordable agent with a low side-effect profile to prevent symptomatic COVID-19. Early use of bromhexine potentially provides another layer of protection; hence, it can play a role in controlling the pandemic.en
DOIhttps://doi.org/10.5812/jjm-130198en
KeywordBromhexineen
KeywordCOVID-19en
KeywordPost-exposure Prophylaxisen
KeywordRandomized Controlled Trialen
PublisherBrieflandsen
TitleBromhexine for Post-exposure COVID-19 Prophylaxis: A Randomized, Double-blind, Placebo-controlled Trialen
TypeResearch Articleen

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