Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients.

Autor: Klussmann JP; Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.; Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany., Grosheva M; Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany., Meiser P; URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129, Saarbruecken, Germany., Lehmann C; Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.; Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.; German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. 62, 50937, Cologne, Germany., Nagy E; CEBINA GmbH, Karl-Farkas-Gasse 22, 1030, Vienna, Austria., Szijártó V; CEBINA GmbH, Karl-Farkas-Gasse 22, 1030, Vienna, Austria., Nagy G; CEBINA GmbH, Karl-Farkas-Gasse 22, 1030, Vienna, Austria., Konrat R; Department of Structural and Computational Biology, Max F. Perutz Laboratories, University of Vienna, Dr.-Bohr-Gasse 9, 1030, Vienna, Austria., Flegel M; URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129, Saarbruecken, Germany., Holzer F; URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129, Saarbruecken, Germany., Groß D; URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129, Saarbruecken, Germany., Steinmetz C; URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129, Saarbruecken, Germany., Scherer B; URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129, Saarbruecken, Germany., Gruell H; Laboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany., Schlotz M; Laboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany., Klein F; German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. 62, 50937, Cologne, Germany.; Laboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany., de Aragão PA; Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany., Morr H; Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany., Al Saleh H; Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany., Bilstein A; Ursatec GmbH, Marpinger Weg 4, 66636, Tholey, Germany., Russo B; ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany., Müller-Scholtz S; ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany., Acikel C; ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany., Sahin H; ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany., Werkhäuser N; ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany., Allekotte S; ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany., Mösges R; ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany. ralph@moesges.de.; Institute of Medical Statistics and Computational Biology (IMSB), Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. ralph@moesges.de.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2023 Apr 26; Vol. 13 (1), pp. 6839. Date of Electronic Publication: 2023 Apr 26.
DOI: 10.1038/s41598-023-32546-z
Abstrakt: With the changing epidemiology of COVID-19 and its impact on our daily lives, there is still an unmet need of COVID-19 therapies treating early infections to prevent progression. The current study was a randomized, parallel, double-blind, placebo-controlled trial. Ninety SARS-CoV-2 positive patients were randomized into 3 groups receiving placebo, 0.02% or 0.1% azelastine nasal spray for 11 days, during which viral loads were assessed by quantitative PCR. Investigators assessed patients' status throughout the trial including safety follow-ups (days 16 and 60). Symptoms were documented in patient diaries. Initial viral loads were log 10 6.85 ± 1.31 (mean ± SD) copies/mL (ORF 1a/b gene). After treatment, virus load was reduced in all groups (p < 0.0001) but was greater in the 0.1% group compared to placebo (p = 0.007). In a subset of patients (initial Ct < 25) viral load was strongly reduced on day 4 in the 0.1% group compared to placebo (p = 0.005). Negative PCR results appeared earlier and more frequently in the azelastine treated groups: being 18.52% and 21.43% in the 0.1% and 0.02% groups, respectively, compared to 0% for placebo on day 8. Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. The shown effects of azelastine nasal spray may thus be suggestive of azelastine's potential as an antiviral treatment.Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). EudraCT number: 2020-005544-34.
(© 2023. The Author(s).)
Databáze: MEDLINE
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