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Development and Characterization of Inhaled Ethanol as a Novel Pharmacological Strategy Currently Evaluated in a Phase II Clinical Trial for Early-Stage SARS-CoV-2 Infection

Authors :
Ana Castro-Balado
Cristina Mondelo-García
Letricia Barbosa-Pereira
Iria Varela-Rey
Ignacio Novo-Veleiro
Néstor Vázquez-Agra
José Ramón Antúnez-López
Enrique José Bandín-Vilar
Raquel Sendón-García
Manuel Busto-Iglesias
Ana Rodríguez-Bernaldo de Quirós
Laura García-Quintanilla
Miguel González-Barcia
Irene Zarra-Ferro
Francisco J. Otero-Espinar
David Rey-Bretal
José Ramón Lago-Quinteiro
Luis Valdés-Cuadrado
Carlos Rábade-Castedo
María Carmen del Río-Garma
Carlos Crespo-Diz
Olga Delgado-Sánchez
Pablo Aguiar
Gema Barbeito-Castiñeiras
María Luisa Pérez del Molino-Bernal
Rocío Trastoy-Pena
Rossana Passannante
Jordi Llop
Antonio Pose-Reino
Anxo Fernández-Ferreiro
Source :
Pharmaceutics, Vol 13, Iss 3, p 342 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

Abstract

Inhaled administration of ethanol in the early stages of COVID-19 would favor its location on the initial replication sites, being able to reduce the progression of the disease and improving its prognosis. Before evaluating the efficacy and safety of this novel therapeutic strategy in humans, its characterization is required. The developed 65° ethanol formulation is stable at room temperature and protected from light for 15 days, maintaining its physicochemical and microbiological properties. Two oxygen flows have been tested for its administration (2 and 3 L/min) using an automated headspace gas chromatographic analysis technique (HS-GC-MS), with that of 2 L/min being the most appropriate one, ensuring the inhalation of an ethanol daily dose of 33.6 ± 3.6 mg/min and achieving more stable concentrations during the entire treatment (45 min). Under these conditions of administration, the formulation has proven to be safe, based on histological studies of the respiratory tracts and lungs of rats. On the other hand, these results are accompanied by the first preclinical molecular imaging study with radiolabeled ethanol administered by this route. The current ethanol formulation has received approval from the Spanish Agency of Medicines and Medical Devices for a phase II clinical trial for early-stage COVID-19 patients, which is currently in the recruitment phase (ALCOVID-19; EudraCT number: 2020-001760-29).

Details

Language :
English
ISSN :
19994923
Volume :
13
Issue :
3
Database :
Directory of Open Access Journals
Journal :
Pharmaceutics
Publication Type :
Academic Journal
Accession number :
edsdoj.7d1e49fcc0bb49219894ecba2adc497f
Document Type :
article
Full Text :
https://doi.org/10.3390/pharmaceutics13030342