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Early Start of Oral Clarithromycin Is Associated with Better Outcome in COVID-19 of Moderate Severity: The ACHIEVE Open-Label Single-Arm Trial

INTRODUCTION: The anti-inflammatory effect of macrolides prompted the study of oral clarithromycin in moderate COVID-19. METHODS: An open-label non-randomized trial in 90 patients with COVID-19 of moderate severity was conducted between May and October 2020. The primary endpoint was defined at the e...

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Detalles Bibliográficos
Autores principales: Tsiakos, Konstantinos, Tsakiris, Antonios, Tsibris, Georgios, Voutsinas, Pantazis-Michael, Panagopoulos, Periklis, Kosmidou, Maria, Petrakis, Vasileios, Gravvani, Areti, Gkavogianni, Theologia, Klouras, Eleftherios, Katrini, Konstantina, Koufargyris, Panagiotis, Rapti, Iro, Karageorgos, Athanassios, Vrentzos, Emmanouil, Damoulari, Christina, Zarkada, Vagia, Sidiropoulou, Chrysanthi, Artemi, Sofia, Ioannidis, Anastasios, Papapostolou, Androniki, Michelakis, Evangelos, Georgiopoulou, Maria, Myrodia, Dimitra-Melia, Tsiamalos, Panteleimon, Syrigos, Konstantinos, Chrysos, George, Nitsotolis, Thomas, Milionis, Haralampos, Poulakou, Garyphallia, Giamarellos-Bourboulis, Evangelos J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8345236/
https://www.ncbi.nlm.nih.gov/pubmed/34363189
http://dx.doi.org/10.1007/s40121-021-00505-8
Descripción
Sumario:INTRODUCTION: The anti-inflammatory effect of macrolides prompted the study of oral clarithromycin in moderate COVID-19. METHODS: An open-label non-randomized trial in 90 patients with COVID-19 of moderate severity was conducted between May and October 2020. The primary endpoint was defined at the end of treatment (EOT) as no need for hospital re-admission and no progression into lower respiratory tract infection (LRTI) for patients with upper respiratory tract infection and as at least 50% decrease of the respiratory symptoms score without progression into severe respiratory failure (SRF) for patients with LRTI. Viral load, biomarkers, the function of mononuclear cells and safety were assessed. RESULTS: The primary endpoint was attained in 86.7% of patients treated with clarithromycin (95% CIs 78.1–92.2%); this was 91.7% and 81.4% among patients starting clarithromycin the first 5 days from symptoms onset or later (odds ratio after multivariate analysis 6.62; p 0.030). The responses were better for patients infected by non-B1.1 variants. Clarithromycin use was associated with decreases in circulating C-reactive protein, tumour necrosis factor-alpha and interleukin (IL)-6; by increase of production of interferon-gamma and decrease of production of interleukin-6 by mononuclear cells; and by suppression of SARS-CoV-2 viral load. No safety concerns were reported. CONCLUSIONS: Early clarithromycin treatment provides most of the clinical improvement in moderate COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04398004 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-021-00505-8.