Results of Open-Label non-Randomized Comparative Clinical Trial: “BromhexIne and Spironolactone for CoronаvirUs Infection requiring hospiTalization (BISCUIT)

12/3 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)

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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.

Mareev et al., 12/3/2020, Randomized Controlled Trial, Russia, Europe, peer-reviewed, 20 authors.

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%), odds ratio converted to relative risk.

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 (with reciprocal of the contrasting arm), day 10.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. For an individual study the most serious outcome may have a smaller number of events and lower statistical signficance, however this provides the strongest evidence for the most serious outcomes when combining the results of many trials.

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