Preprint Article Version 1 This version is not peer-reviewed

Azelastine Nasal Spray in Non-Hospitalised Subjects with Mild COVID-19 Infection: A Randomized Placebo-Controlled, Parallel-Group, Multicentric, Phase II Clinical Trial

Version 1 : Received: 30 October 2024 / Approved: 31 October 2024 / Online: 31 October 2024 (08:41:03 CET)

How to cite: Meiser, P.; Flegel, M.; Holzer, F.; Groß, D.; Steinmetz, C.; Scherer, B.; Jain, R. Azelastine Nasal Spray in Non-Hospitalised Subjects with Mild COVID-19 Infection: A Randomized Placebo-Controlled, Parallel-Group, Multicentric, Phase II Clinical Trial. Preprints 2024, 2024102532. https://doi.org/10.20944/preprints202410.2532.v1 Meiser, P.; Flegel, M.; Holzer, F.; Groß, D.; Steinmetz, C.; Scherer, B.; Jain, R. Azelastine Nasal Spray in Non-Hospitalised Subjects with Mild COVID-19 Infection: A Randomized Placebo-Controlled, Parallel-Group, Multicentric, Phase II Clinical Trial. Preprints 2024, 2024102532. https://doi.org/10.20944/preprints202410.2532.v1

Abstract

Availability of 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, double-blind, 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-2 infected subjects estimated via quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) using nasopharyngeal swabs in both the groups during the treatment period. A total of 294 subjects with mild COVID-19 infection were screened and randomized in a 1:1 ratio.

Keywords

COVID-19; Azelastine; Nasal Spray; SARS-CoV-2; Viral load; COVID-19 related hospitalization; Clinical Trial

Subject

Medicine and Pharmacology, Epidemiology and Infectious Diseases

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