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

Autor: Yu L Begrambekova, M M Bulanova, P V Pakhomov, А А Kamalov, V Yu Mareev, E M Seredenina, L M Samokhodskaya, A G Plisyk, A V Potapenko, Z A Akopyan, Valentin Sinitsyn, A A Fuks, L I Dyachuk, S T Matskeplishvili, D A Asratyan, Е А Mershina, E P Pavlikova, M A Agapov, Yu V Mareev, Ya A Orlova
Rok vydání: 2020
Předmět:
Zdroj: Kardiologiia. 60(11)
ISSN: 0022-9040
Popis: Introduction 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.Material and methods 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.Results 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, pConclusion 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).
Databáze: OpenAIRE