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, showing lower PCR+ at day 10 or hospitalization >10 days with treatment. Bromhexine 8mg 4 times daily, spironolactone 25-50 mg/day for 10 days.
Bromhexine efficacy may vary depending on the degree of TMPRSS-dependent fusion for different variants
Peacock, Willett.
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relative SHOKS-COVID score, 11.3% better, RR 0.89, p = 0.47, treatment mean 2.12 (±1.39) n=33, control mean 2.39 (±1.59) n=33.
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risk of PCR+ on day 10 or hospitalization >10 days, 38.8% lower, RR 0.61, p = 0.02, treatment 14 of 24 (58.3%), control 20 of 21 (95.2%), NNT 2.7, odds ratio converted to relative risk.
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hospitalization time, 8.2% lower, relative time 0.92, p = 0.35, treatment 33, control 33.
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risk of no viral clearance, 87.4% lower, RR 0.13, p = 0.08, treatment 0 of 17 (0.0%), control 3 of 13 (23.1%), NNT 4.3, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 10.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Mareev et al., 3 Dec 2020, Randomized Controlled Trial, Russia, peer-reviewed, 20 authors, this trial uses multiple treatments in the treatment arm (combined with spironolactone) - results of individual treatments may vary, trial
NCT04424134 (history).
Abstract: §
EDITORIAL ARTICLES
Mareev V. Yu.1,2, Orlova Ya.A.1,2, Plisyk A.G.1,2, Pavlikova E.P.1,2, Matskeplishvili S.Т.1,
Akopyan Z.A.1,2, Seredenina E. M.1,2, Potapenko A. V.1,2, Agapov M.A.1,2, Asratyan D.A.1,
Dyachuk L.I.1,2, Samokhodskaya L. M.1,2, Mershina Е. А.1,2, Sinitsyn V. E.1,2, Pakhomov P. V.2,
Bulanova M.M.2, Fuks A.A.2, Mareev Yu.V.3,4, Begrambekova Yu. L.1,2, Kamalov А. А.1,2
Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia
Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia
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National Medical Research Centre for Therapy and Preventive Medicine Moscow, Russia
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Robertson Centre for Biostatistics, Glasgow, Great Britain
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2
Results of Open-Label non-Randomized Comparative
Clinical Trial: “BromhexIne and Spironolactone for
CoronаvirUs Infection requiring hospiTalization (BISCUIT)
Late treatment
is less effective
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