Efficacy of Bromhexine versus Standard of Care in Reducing Viral Load in Patients with Mild-to-Moderate COVID-19 Disease Attended in Primary Care: A Randomized Open-Label Trial

{ 'indexed': { 'date-parts': [[2022, 12, 30]], 'date-time': '2022-12-30T06:09:20Z', 'timestamp': 1672380560206}, 'reference-count': 24, 'publisher': 'MDPI AG', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2022, 12, 24]], 'date-time': '2022-12-24T00:00:00Z', 'timestamp': 1671840000000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0/'}], 'funder': [ {'name': 'CSIC', 'award': ['PIE 201980E024']}, {'name': 'European Commission: NextGeneration EU', 'award': ['EU 2020/2094']}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'abstract': '<jats:p>A 28-day randomized open-label multicenter study was conducted to assess the efficacy ' 'of bromhexine plus standard of care (SOC) (n = 98) vs. SOC alone (n = 93) in 191 outpatients ' 'with mild-to-moderate COVID-19 in the primary health care setting. Bromhexine three daily ' 'doses of 10 mL (48 mg/day) were administered for seven days. The primary efficacy endpoint ' 'was the reduction of viral load estimated as the cycle thresholds (Ct) to detect ORF1ab, N ' 'Protein, and S Protein genes by RT-qPCR in saliva samples on day 4 as compared with baseline. ' 'Ct values of the three genes increased from baseline throughout days 4 to 14 (p &lt; 0.001) ' 'but significant differences between the study groups were not found. Differences in the ' 'percentages of patients with low, medium, and high viral loads at 4, 7, and 14 days were not ' 'found either. In summary, treatment with bromhexine plus SCO was associated with a viral load ' 'reduction of ORF1ab, N Protein, and S Protein genes at day 4, which was not significantly ' 'different than similar viral load reductions observed with SOC alone. The present findings do ' 'not seem to favor the use of bromhexine as an antiviral in patients with COVID-19.</jats:p>', 'DOI': '10.3390/jcm12010142', 'type': 'journal-article', 'created': { 'date-parts': [[2022, 12, 27]], 'date-time': '2022-12-27T07:53:11Z', 'timestamp': 1672127591000}, 'page': '142', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Efficacy of Bromhexine versus Standard of Care in Reducing Viral Load in Patients with ' 'Mild-to-Moderate COVID-19 Disease Attended in Primary Care: A Randomized Open-Label Trial', 'prefix': '10.3390', 'volume': '12', 'author': [ {'given': 'María Luz', 'family': 'Vila Méndez', 'sequence': 'first', 'affiliation': []}, {'given': 'Carmen', 'family': 'Antón Sanz', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Alicia del Rocío', 'family': 'Cárdenas García', 'sequence': 'additional', 'affiliation': []}, {'given': 'Amparo', 'family': 'Bravo Malo', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Francisco Javier', 'family': 'Torres Martínez', 'sequence': 'additional', 'affiliation': []}, {'given': 'José María', 'family': 'Martín Moros', 'sequence': 'additional', 'affiliation': []}, {'given': 'María', 'family': 'Real Torrijos', 'sequence': 'additional', 'affiliation': []}, { 'given': 'José Francisco Javier', 'family': 'Vendrell Covisa', 'sequence': 'additional', 'affiliation': []}, {'given': 'Olga', 'family': 'Guzmán Sierra', 'sequence': 'additional', 'affiliation': []}, {'given': 'Verónica', 'family': 'Molina Barcena', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nuria', 'family': 'Viejo Pinero', 'sequence': 'additional', 'affiliation': []}, {'given': 'Carlos', 'family': 'Fernández Díaz', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Purificación', 'family': 'Arroyo Burguillo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ana María', 'family': 'Blanco Gallego', 'sequence': 'additional', 'affiliation': []}, {'given': 'Carmen', 'family': 'Guirao Sánchez', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Aránzazu', 'family': 'Montilla Bernabé', 'sequence': 'additional', 'affiliation': []}, { 'given': 'María del Pilar', 'family': 'Villanueva Morán', 'sequence': 'additional', 'affiliation': []}, {'given': 'Salvador', 'family': 'Juárez Antón', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Ángela', 'family': 'Fernández Rodríguez', 'sequence': 'additional', 'affiliation': []}, { 'given': 'María Ángeles', 'family': 'Somoza Calvo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ernesto Cerrada', 'family': 'Cerrada', 'sequence': 'additional', 'affiliation': []}, {'given': 'Gemma', 'family': 'Pérez Mañas', 'sequence': 'additional', 'affiliation': []}, {'given': 'Antonio', 'family': 'Sánchez Calso', 'sequence': 'additional', 'affiliation': []}, {'given': 'Frida', 'family': 'Vallejo Somohano', 'sequence': 'additional', 'affiliation': []}, {'given': 'Carmen', 'family': 'Cauqui Díaz', 'sequence': 'additional', 'affiliation': []}, {'given': 'Gloria', 'family': 'Viñas Fernández', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-4716-3152', 'authenticated-orcid': False, 'given': 'Jesús', 'family': 'Molina París', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marina', 'family': 'González Godoy', 'sequence': 'additional', 'affiliation': []}, {'given': 'Gonzalo', 'family': 'Lumbreras García', 'sequence': 'additional', 'affiliation': []}, {'given': 'Javier', 'family': 'Rosado Martín', 'sequence': 'additional', 'affiliation': []}, {'given': 'Aida', 'family': 'Rodríguez Hernández', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sara', 'family': 'López Antúñez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Gabriel', 'family': 'Vázquez Perfecto', 'sequence': 'additional', 'affiliation': []}, { 'given': 'María Concepción', 'family': 'Marcello Andrés', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Nieves Marina', 'family': 'Puente García', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-3882-6081', 'authenticated-orcid': False, 'given': 'Carmen', 'family': 'Gil', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-2707-8110', 'authenticated-orcid': False, 'given': 'Ana', 'family': 'Martínez', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-5853-2307', 'authenticated-orcid': False, 'given': 'Begoña', 'family': 'Soler López', 'sequence': 'additional', 'affiliation': []}], 'member': '1968', 'published-online': {'date-parts': [[2022, 12, 24]]}, 'reference': [ { 'key': 'ref_1', 'doi-asserted-by': 'crossref', 'first-page': '685', 'DOI': '10.2147/DDDT.S354841', 'article-title': 'A systematic Review of the global intervention for SARS-CoV-2 ' 'combating: From drugs repurposing to molnupiravir approval', 'volume': '16', 'author': 'Ashour', 'year': '2022', 'journal-title': 'Drug Des. 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