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
3
National Medical Research Centre for Therapy and Preventive Medicine Moscow, Russia
4
Robertson Centre for Biostatistics, Glasgow, Great Britain
1
2
Results of Open-Label non-Randomized Comparative
Clinical Trial: “BromhexIne and Spironolactone for
CoronаvirUs Infection requiring hospiTalization (BISCUIT)
{ 'indexed': {'date-parts': [[2024, 1, 9]], 'date-time': '2024-01-09T20:13:22Z', 'timestamp': 1704831202976},
'reference-count': 42,
'publisher': 'APO Society of Specialists in Heart Failure',
'issue': '11',
'license': [ { 'start': { 'date-parts': [[2020, 12, 3]],
'date-time': '2020-12-03T00:00:00Z',
'timestamp': 1606953600000},
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'abstract': '<jats:p><jats:italic>Introduction</jats:italic> The aim of this study was to assess the '
'efficacy and safety of a combination of bromhexine at a dose of 8 mg 4 times a day and '
'spironolactone 50 mg per day in patients with mild and moderate COVID '
'19.<jats:italic>Material and methods</jats:italic> It was an open, prospective comparative '
'non-randomized study. 103 patients were included (33 in the bromhexine and spironolactone '
'group and 70 in the control group). All patients had a confirmed 2019 novel coronavirus '
'infection (COVID 19) based on a positive polymerase chain reaction (PCR) for SARS-CoV-2 virus '
'RNA and/or a typical pattern of viral pneumonia on multispiral computed tomography. The '
'severity of lung damage was limited to stage I-II, the level of CRP should not exceed 60 mg / '
'dL and SO2 in the air within 92-98%. The duration of treatment is 10 '
'days.<jats:italic>Results</jats:italic> The decrease in scores on the SHOKS-COVID scale, '
'which, in addition to assessing the clinical status, the dynamics of CRP (a marker of '
'inflammation), D-dimer (a marker of thrombus formation), and the degree of lung damage on CT '
'(primary endpoint) was statistically significant in both groups and differences between them '
'was not identified. Analysis for the group as a whole revealed a statistically significant '
'reduction in hospitalization time from 10.4 to 9.0 days (by 1.5 days, p=0.033) and fever time '
'from 6.5 to 3.9 days (by 2.5 days, p<0.001). Given the incomplete balance of the groups, '
'the main analysis included 66 patients who were match with using propensity score matching. '
'In matched patients, temperature normalization in the bromhexine/spironolactone group '
'occurred 2 days faster than in the control group (p=0.008). Virus elimination by the 10th day '
'was recorded in all patients in the bromhexine/spironolactone group; the control group '
'viremia continued in 23.3% (p=0.077). The number of patients who had a positive PCR to the '
'SARS-CoV-2 virus on the 10th day of hospitalization or longer (≥10 days) hospitalization in '
'the control group was 20/21 (95.2%), and in the group with bromhexine /spironolactone -14/24 '
'(58.3%), p=0.012. The odds ratio of having a positive PCR or more than ten days of '
'hospitalization was 0.07 (95% CI: 0.008 - 0.61, p=0.0161) with bromhexine and spironolactone '
'versus controls. No side effects were reported in the study '
'group.<jats:italic>Conclusion</jats:italic> The combination of bromhexine with spironolactone '
'appeared effective in treating a new coronavirus infection by achieving a faster '
'normalization of the clinical condition, lowering the temperature one and a half times '
'faster, and reducing explanatory combine endpoint the viral load or long duration of '
'hospitalization (≥ 10 days).</jats:p>',
'DOI': '10.18087/cardio.2020.11.n1440',
'type': 'journal-article',
'created': {'date-parts': [[2021, 1, 25]], 'date-time': '2021-01-25T08:30:07Z', 'timestamp': 1611563407000},
'page': '4-15',
'source': 'Crossref',
'is-referenced-by-count': 16,
'title': 'Results of Open-Label non-Randomized Comparative Clinical Trial: “BromhexIne and Spironolactone '
'for CoronаvirUs Infection requiring hospiTalization (BISCUIT)',
'prefix': '10.18087',
'volume': '60',
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