Azelastine Nasal Spray in Non-Hospitalized Subjects with Mild COVID-19 Infection: A Randomized Placebo-Controlled, Parallel-Group, Multicentric, Phase II Clinical Trial
Peter Meiser, Michael Flegel, Frank Holzer, Dorothea Groß, Charlotte Steinmetz, Barbara Scherer, Rajesh Jain
Viruses, doi:10.3390/v16121914
Nasal spray treatments that inhibit the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) entry into nose and nasopharynx at early stages can be an appropriate approach to stop or delay the progression of the disease. We performed a prospective, randomized, doubleblind, placebo-controlled, parallel-group, multicentric, phase II clinical trial comparing the rate of hospitalization due to COVID-19 infection between azelastine 0.1% nasal spray and placebo nasal spray treatment groups. The study furthermore assessed the reduction in virus load in SARS-CoV-2infected subjects estimated via quantitative reverse transcriptase polymerase chain reaction (RT-PCR) using nasopharyngeal swabs in both groups during the treatment period. A total of 294 subjects with mild COVID-19 infection were screened and randomized in a 1:1 ratio. There was no incidence of COVID-19-related hospitalization in either treatment group. Mean virus load was significantly reduced in both groups during the 11 treatment days as compared with baseline viral load values. The reduction in virus load in the azelastine 0.1% nasal spray group was significantly higher than the reduction in the placebo group at day 11 (log 10 5.93 vs. log 10 5.85 copies/mL, respectively, p = 0.0041). A total of 39 (32.0%) subjects in the azelastine 0.1% treatment group and 40 (31.0%) subjects in the placebo group reported 48 and 51 adverse events, respectively. It is therefore concluded that azelastine 0.1% nasal spray is an efficacious, safe, and well-tolerated treatment of mild COVID-19 infection.
Supplementary Materials: The following supporting information can be downloaded at https:// www.mdpi.com/article/10.3390/v16121914/s1 : Table S1 : List of IECs or IRBs; Table S2 : Inclusion and Exclusion Criteria; Table S3 : Randomization Procedure; S10 : Overall Summary of Adverse Events (Safety Population). Author Contributions: Conceptualization, P.M., M.F. and F.H.; methodology, P.M. and R.J.; software, R.J.; validation, R.J.; formal analysis, P.M., D.G., C.S., B.S. and R.J.; investigation, CARVIN-II Study Group; resources, P.M., R.J. and F.H.; data curation, R.J.; writing-original draft preparation, R.J.; writing-review and editing, P.M. and all involved authors; supervision, P.M.; project administration, P.M. All authors have read and agreed to the published version of the manuscript. Funding: This research received no external funding. The Clinical Trial was funded by URSAPHARM Arzneimittel GmbH.
Institutional Review Board Statement: The study was approved by all involved Institutional Review Boards and Ethics Committees. A full list of the Institutional Review Boards and Ethics Committees involved is provided in the Supplementary Table S1 . The study was conducted in accordance with the Good Clinical Practice, the Declaration of Helsinki, and all applicable local and national regulatory requirements. Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Conflicts of Interest: Peter Meiser, Michael Flegel,..
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