Bromhexine for COVID-19: real-time analysis of all 5 studies

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3/15	Late	Tolouian et al., J. Investig. Med., doi:10.1136/jim-2020-001747 (Peer Reviewed)	death, ↓76.0%, p=0.43	Effect of bromhexine in hospitalized patients with COVID-19
	Details Small RCT with 100 patients, 48 with bromhexine added to SOC, showing slower viral- conversion but lower mortality and greater clinical improvement with bromhexine (not statistically significant with few deaths and very high recovery). Th..
3/15	Details Source PDF Late treatment study Late treatment study
	Tolouian et al., J. Investig. Med., doi:10.1136/jim-2020-001747 (Peer Reviewed)
	Effect of bromhexine in hospitalized patients with COVID-19
	Small RCT with 100 patients, 48 with bromhexine added to SOC, showing slower viral- conversion but lower mortality and greater clinical improvement with bromhexine (not statistically significant with few deaths and very high recovery). The very large difference between unadjusted and adjusted results is due to much higher risk for patients with renal disease and the much higher prevalence of renal disease in the bromhexine group. The study also shows 90% of patients in the control group had BMI>=30 compared to 0% in the treatment group, suggesting a possible problem with randomization. Due to the imbalance between groups, results were adjusted for BMI>30, smoking, and renal disease. 11 patients were lost to followup in the treatment group compared to zero in the control group, perhaps in part due to faster recovery in the treatment group. 9 patients were excluded from the treatment group because they did not want to take bromhexine after discharge. Therefore up to 29% of treatment patients may have been excluded because they recovered quickly. risk of death, 76.0% lower, RR 0.24, p = 0.43, treatment 48, control 52, Table 3, adjusted. risk of no improvement, 75.9% lower, RR 0.24, p = 0.43, treatment 48, control 52, Table 2, adjusted. risk of COVID-19 case, 74.5% higher, RR 1.75, p = 0.02, treatment 29 of 48 (60.4%), control 18 of 52 (34.6%), mid-recovery day 7. Tolouian et al., 3/15/2021, Randomized Controlled Trial, Iran, Middle East, peer-reviewed, 7 authors.
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3/8	PrEP	Mikhaylov et al., medRxiv, doi:10.1101/2021.03.03.21252855 (Preprint)	hosp., ↓80.0%, p=0.49	Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study
	Details Small prophylaxis RCT with 25 treatment and 25 control health care worker, showing lower PCR+, symptomatic cases, and hospitalization with treatment, although not statistically significant with the small sample size.
3/8	Details Source PDF Pre-Exposure Prophylaxis study Pre-Exposure Prophylaxis study
	Mikhaylov et al., medRxiv, doi:10.1101/2021.03.03.21252855 (Preprint)
	Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study
	Small prophylaxis RCT with 25 treatment and 25 control health care worker, showing lower PCR+, symptomatic cases, and hospitalization with treatment, although not statistically significant with the small sample size. risk of hospitalization, 80.0% lower, RR 0.20, p = 0.49, treatment 0 of 25 (0.0%), control 2 of 25 (8.0%), continuity correction due to zero event. risk of symptomatic case, 90.9% lower, RR 0.09, p = 0.05, treatment 0 of 25 (0.0%), control 5 of 25 (20.0%), continuity correction due to zero event. risk of no virological cure, 71.4% lower, RR 0.29, p = 0.14, treatment 2 of 25 (8.0%), control 7 of 25 (28.0%). Mikhaylov et al., 3/8/2021, Randomized Controlled Trial, Russia, Asia, preprint, 8 authors.
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12/31	Review	Al-Kuraishy et al., Current Medical and Drug Research (Review) (Peer Reviewed)	review	The potential role of Bromhexine in the management of COVID-19: Decipher and a real game-changer
	Details Review article noting that bromhexine is a TMPRSS2 inhibitor with greater effect in lung tissue and attenuates the entry and proliferation of SARS‐CoV‐2.
12/31	Details Source PDF Review Review
	Al-Kuraishy et al., Current Medical and Drug Research (Review) (Peer Reviewed)
	The potential role of Bromhexine in the management of COVID-19: Decipher and a real game-changer
	Review article noting that bromhexine is a TMPRSS2 inhibitor with greater effect in lung tissue and attenuates the entry and proliferation of SARS‐CoV‐2. Al-Kuraishy et al., 12/31/2020, peer-reviewed, 5 authors.
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12/3	Late	Mareev et al., Кардиология, doi:10.18087/cardio.2020.11.n1440 (Peer Reviewed)	no disch., ↓38.8%, p=0.02	Results of Open-Label non-Randomized Comparative Clinical Trial: “BromhexIne and Spironolactone for CoronаvirUs Infection requiring hospiTalization (BISCUIT)
	Details Prospective 103 PCR+ patients in Russia, 33 treated with bromexhine+spironolactone. The odds ratio of having a positive PCR or hospitalization for ≥10 days was 0.07 [0.008–0.61] with treatment. Dosing was bromhexine 8mg 4 times daily, sp..
12/3	Details Source PDF Late treatment study Late treatment study
	Mareev et al., Кардиология, doi:10.18087/cardio.2020.11.n1440 (Peer Reviewed)
	Results of Open-Label non-Randomized Comparative Clinical Trial: “BromhexIne and Spironolactone for CoronаvirUs Infection requiring hospiTalization (BISCUIT)
	Prospective 103 PCR+ patients in Russia, 33 treated with bromexhine+spironolactone. The odds ratio of having a positive PCR or hospitalization for ≥10 days was 0.07 [0.008–0.61] with treatment. Dosing was bromhexine 8mg 4 times daily, spironolactone 25-50 mg/day for 10 days. risk of PCR+ on day 10 and hospitalization > 10 days, 38.8% lower, RR 0.61, p = 0.02, treatment 14 of 24 (58.3%), control 20 of 21 (95.2%), OR converted to RR. risk of no virological cure, 87.4% lower, RR 0.13, p = 0.08, treatment 0 of 17 (0.0%), control 3 of 13 (23.1%), continuity correction due to zero event, day 10. Mareev et al., 12/3/2020, Randomized Controlled Trial, Russia, Asia, Europe, peer-reviewed, 20 authors.
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9/3	Early	Li et al., Clinical and Translational Science, doi:10.1111/cts.12881 (Peer Reviewed)	no disch., ↓75.0%, p=0.11	Bromhexine Hydrochloride Tablets for the Treatment of Moderate COVID‐19: An Open‐Label Randomized Controlled Pilot Study
	Details Tiny RCT with 12 bromhexine and 6 control patients showing non-statistically significant improvements in chest CT, need for oxygen therapy, and discharge rate within 20 days. Authors recommend a larger scale trial.
9/3	Details Source PDF Early treatment study Early treatment study
	Li et al., Clinical and Translational Science, doi:10.1111/cts.12881 (Peer Reviewed)
	Bromhexine Hydrochloride Tablets for the Treatment of Moderate COVID‐19: An Open‐Label Randomized Controlled Pilot Study
	Tiny RCT with 12 bromhexine and 6 control patients showing non-statistically significant improvements in chest CT, need for oxygen therapy, and discharge rate within 20 days. Authors recommend a larger scale trial. risk of no hospital discharge, 75.0% lower, RR 0.25, p = 0.11, treatment 2 of 12 (16.7%), control 4 of 6 (66.7%). risk of oxygen therapy, 50.0% lower, RR 0.50, p = 0.57, treatment 2 of 12 (16.7%), control 2 of 6 (33.3%). recovery time, 3.2% higher, relative time 1.03, treatment 12, control 6. Li et al., 9/3/2020, Randomized Controlled Trial, China, Asia, peer-reviewed, 10 authors.
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7/19	Early	Ansarin et al., Bioimpacts, doi:10.34172/bi.2020.27 (Peer Reviewed)	death, ↓90.9%, p=0.05	Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial
	Details RCT with 39 bromhexine and 39 control patients showing lower mortality, intubation, and ICU admission with treatment. The treatment group received bromhexine hydrochloride 8 mg three times a day for two weeks. All patients received SOC in..
7/19	Details Source PDF Early treatment study Early treatment study
	Ansarin et al., Bioimpacts, doi:10.34172/bi.2020.27 (Peer Reviewed)
	Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial
	RCT with 39 bromhexine and 39 control patients showing lower mortality, intubation, and ICU admission with treatment. The treatment group received bromhexine hydrochloride 8 mg three times a day for two weeks. All patients received SOC including HCQ. risk of death, 90.9% lower, RR 0.09, p = 0.05, treatment 0 of 39 (0.0%), control 5 of 39 (12.8%), continuity correction due to zero event. risk of mechanical ventilation, 88.9% lower, RR 0.11, p = 0.01, treatment 1 of 39 (2.6%), control 9 of 39 (23.1%). risk of ICU admission, 81.8% lower, RR 0.18, p = 0.01, treatment 2 of 39 (5.1%), control 11 of 39 (28.2%). Ansarin et al., 7/19/2020, Randomized Controlled Trial, Iran, Middle East, peer-reviewed, 11 authors.
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