Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients
Abstract 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...
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2023-04-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-023-32546-z |
| _version_ | 1797836484466704384 |
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| author | Jens Peter Klussmann Maria Grosheva Peter Meiser Clara Lehmann Eszter Nagy Valéria Szijártó Gábor Nagy Robert Konrat Michael Flegel Frank Holzer Dorothea Groß Charlotte Steinmetz Barbara Scherer Henning Gruell Maike Schlotz Florian Klein Paula Aguiar de Aragão Henning Morr Helal Al Saleh Andreas Bilstein Belisa Russo Susanne Müller-Scholtz Cengizhan Acikel Hacer Sahin Nina Werkhäuser Silke Allekotte Ralph Mösges |
| author_facet | Jens Peter Klussmann Maria Grosheva Peter Meiser Clara Lehmann Eszter Nagy Valéria Szijártó Gábor Nagy Robert Konrat Michael Flegel Frank Holzer Dorothea Groß Charlotte Steinmetz Barbara Scherer Henning Gruell Maike Schlotz Florian Klein Paula Aguiar de Aragão Henning Morr Helal Al Saleh Andreas Bilstein Belisa Russo Susanne Müller-Scholtz Cengizhan Acikel Hacer Sahin Nina Werkhäuser Silke Allekotte Ralph Mösges |
| author_sort | Jens Peter Klussmann |
| collection | DOAJ |
| description | Abstract 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 log10 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. |
| first_indexed | 2024-04-09T15:09:47Z |
| format | Article |
| id | doaj.art-6a4de9c597c74fe1adf2c213f26a7b9e |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-04-09T15:09:47Z |
| publishDate | 2023-04-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-6a4de9c597c74fe1adf2c213f26a7b9e2023-04-30T11:16:20ZengNature PortfolioScientific Reports2045-23222023-04-0113111210.1038/s41598-023-32546-zEarly intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patientsJens Peter Klussmann0Maria Grosheva1Peter Meiser2Clara Lehmann3Eszter Nagy4Valéria Szijártó5Gábor Nagy6Robert Konrat7Michael Flegel8Frank Holzer9Dorothea Groß10Charlotte Steinmetz11Barbara Scherer12Henning Gruell13Maike Schlotz14Florian Klein15Paula Aguiar de Aragão16Henning Morr17Helal Al Saleh18Andreas Bilstein19Belisa Russo20Susanne Müller-Scholtz21Cengizhan Acikel22Hacer Sahin23Nina Werkhäuser24Silke Allekotte25Ralph Mösges26Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of CologneMedical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of CologneURSAPHARM Arzneimittel GmbHCenter for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of CologneCEBINA GmbHCEBINA GmbHCEBINA GmbHDepartment of Structural and Computational Biology, Max F. Perutz Laboratories, University of ViennaURSAPHARM Arzneimittel GmbHURSAPHARM Arzneimittel GmbHURSAPHARM Arzneimittel GmbHURSAPHARM Arzneimittel GmbHURSAPHARM Arzneimittel GmbHLaboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital, University of CologneLaboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital, University of CologneGerman Center for Infection Research (DZIF) Location Bonn-CologneMedical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of CologneMedical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of CologneMedical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of CologneUrsatec GmbHClinCompetence Cologne GmbHClinCompetence Cologne GmbHClinCompetence Cologne GmbHClinCompetence Cologne GmbHClinCompetence Cologne GmbHClinCompetence Cologne GmbHClinCompetence Cologne GmbHAbstract 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 log10 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.https://doi.org/10.1038/s41598-023-32546-z |
| spellingShingle | Jens Peter Klussmann Maria Grosheva Peter Meiser Clara Lehmann Eszter Nagy Valéria Szijártó Gábor Nagy Robert Konrat Michael Flegel Frank Holzer Dorothea Groß Charlotte Steinmetz Barbara Scherer Henning Gruell Maike Schlotz Florian Klein Paula Aguiar de Aragão Henning Morr Helal Al Saleh Andreas Bilstein Belisa Russo Susanne Müller-Scholtz Cengizhan Acikel Hacer Sahin Nina Werkhäuser Silke Allekotte Ralph Mösges Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients Scientific Reports |
| title | Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients |
| title_full | Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients |
| title_fullStr | Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients |
| title_full_unstemmed | Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients |
| title_short | Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients |
| title_sort | early intervention with azelastine nasal spray may reduce viral load in sars cov 2 infected patients |
| url | https://doi.org/10.1038/s41598-023-32546-z |
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