Azelastine Nasal Spray in Non-Hospitalized Subjects with Mild COVID-19 Infection: A Randomized Placebo-Controlled,...

Area of Science:

• Virology
• Clinical Pharmacology
• Respiratory Medicine

Background:

• Early-stage nasal spray treatments targeting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) entry may limit disease progression.
• Nasal and nasopharyngeal inhibition of viral entry presents a potential strategy for managing COVID-19.

Purpose of the Study:

• To compare the hospitalization rates due to COVID-19 between azelastine 0.1% nasal spray and placebo.
• To assess the reduction in SARS-CoV-2 virus load in mild COVID-19 patients receiving azelastine 0.1% nasal spray versus placebo.

Main Methods:

• A prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentric, phase II clinical trial.
• 294 subjects with mild COVID-19 infection were randomized (1:1 ratio) to receive azelastine 0.1% nasal spray or placebo.
• Quantitative reverse transcriptase polymerase chain reaction (RT-PCR) was used to measure virus load via nasopharyngeal swabs.

Main Results:

• No COVID-19-related hospitalizations occurred in either the azelastine or placebo groups.
• Mean virus load significantly decreased in both groups during 11 days of treatment compared to baseline.
• Azelastine 0.1% nasal spray demonstrated a significantly higher reduction in virus load at day 11 compared to placebo (log10 5.93 vs. 5.85 copies/mL, p=0.0041).
• Adverse events were comparable between the azelastine (32.0%) and placebo (31.0%) groups.

Conclusions:

• Azelastine 0.1% nasal spray is an effective and safe treatment for mild COVID-19 infection.
• The nasal spray demonstrated significant efficacy in reducing viral load.
• Azelastine 0.1% nasal spray was well-tolerated by participants.