Variants of nan terrible acute respiratory syndrome coronavirus 2 (SARS-CoV-2), nan microorganism responsible for nan coronavirus illness 2019 (COVID-19) pandemic, proceed to look almost six years aft its first emergence. A caller study published in JAMA Internal Medicine discusses nan effects of azelastine nasal spray connected nan complaint of SARS-CoV-2 infection arsenic compared to placebo.
Study: Azelastine Nasal Spray for Prevention of SARS-CoV-2 Infections: A Phase 2 Randomized Clinical Trial. Image Credit: New Africa / Shutterstock.com
The antiviral effects of azelastine
Azelastine is simply a nasal antihistamine spray wide utilized to negociate allergic rhinitis. Recent studies propose that it exhibits antiviral activity in vitro against respective respiratory viruses, including SARS-CoV-2; however, its objective efficacy remains unclear.
These antiviral effects whitethorn originate pursuing antecedently reported interactions betwixt azelastine and nan angiotensin converting enzyme 2 (ACE2) receptor, which is chiefly utilized by SARS-CoV-2 to summation introduction into cells. Other studies propose that azelastine curen inhibits nan SARS-CoV-2 main protease (Mpro) enzyme, which mediates viral attachment to nan big cell. Azelastine besides appears to induce changes successful nan σ-1 receptor and inhibits intercellular adhesion molecule 1 (ICAM-1) expression.
Previous mini randomized tests propose that azelastine reduces nan viral load successful patients pinch SARS-CoV-2 infection, frankincense suggesting its imaginable effectiveness arsenic a preventive. The coming study explored nan effectiveness and information of azelastine nasal spray for reducing nan incidence of SARS-CoV-2 infection.
About nan study
The existent study was a single-center, shape II randomized controlled proceedings comparing nan usage of azelastine nasal spray pinch placebo successful 450 individuals. The mean property of nan study participants was 33 years, astir of whom were female and White.
Women of reproductive property were included only if they were neither pregnant nor breastfeeding and/or were utilizing reliable contraception. A important mostly of study participants received 1 aliases much COVID-19 vaccinations, pinch nan cohort receiving a median of 3 shots. In astir cases, nan astir caller COVID-19 vaccine was administered 2 years earlier nan existent study began.
Study participants were randomly assigned to person 0.1% azelastine aliases placebo nasal spray 3 times each time for a full of 8 weeks. Notably, this dose of azelastine exceeds nan doubly regular usage that is typically prescribed to negociate mean to terrible allergic rhinitis.
Study participants were tested for SARS-CoV-2 infection by accelerated antigen tests (RAT) doubly play passim nan study period, and immoderate affirmative trial consequence was subsequently confirmed by polymerase concatenation guidance (PCR). Study participants who knowledgeable respiratory symptoms but tested antagonistic by RAT besides underwent a PCR trial for SARS-CoV-2 and different respiratory viruses.
Study findings
The azelastine group was little apt to beryllium diagnosed pinch SARS-CoV-2 infection than controls astatine 2% and 6.7%, respectively. This study indicates that azelastine reduces nan consequence of SARS-CoV-2 infection by astir 70%.
Azelastine curen besides delayed nan clip to infection by 12 days arsenic compared to nan placebo group. Symptomatic COVID-19 infections were little apt successful nan azelastine group, pinch azelastine recipients remaining affirmative for SARS-CoV-2 for 1.7 days little than nan power group, arsenic assessed by self-reported RAT.
Even successful times of higher vulnerability rates, less infections per vulnerability occurred nether curen compared pinch placebo.”
Aside from COVID-19, rhinovirus infections were nan astir communal infection reported among study participants. Azelastine curen was likewise recovered to trim nan consequence of rhinovirus infections, pinch 2% of recipients infected arsenic compared to 6% successful nan placebo group.
Overall, respiratory infections, arsenic detected by PCR, affected 9% of nan azelastine group arsenic compared to 22% of controls. Participants who had antibodies indicating anterior SARS-CoV-2 infection showed somewhat little likelihood of testingpositive again, suggesting that baseline immune position modestly inflenced infection risk.
Importantly, adverse events were akin successful wide wave betwixt groups but much commonly considered treatment-related successful nan azelastine group. However, astir of these reactions were insignificant and well-known broadside effects for illustration bitter taste, nosebleeds, and fatigue.
Conclusions
These findings support nan imaginable of azelastine arsenic a safe prophylactic attack warranting confirmation successful larger, multicentric trials.”
The wide complaint of caller viral infections was low, frankincense indicating that azelastine whitethorn person wide antiviral activity. In particular, azelastine conferred protection against symptomatic rhinovirus infection, which whitethorn originate owed to inhibition of nan rhinovirus receptor ICAM-1. The authors noted that this is 1 of nan first objective tests to show reduced rhinovirus infection rates pursuing a azygous therapy.
Azelastine is simply a safe, easy available, and convenient attack for pre-exposure prophylaxis of SARS-CoV-2 infection, which tin beryllium easy utilized successful high-risk settings for illustration nationalist meetings aliases during travel. Nevertheless, nan researchers cautioned that nan study's single-center design, humble sample size, and imaginable unblinding owed to azelastine's bitter sensation limit generalizability. They besides acknowledged that nan placebo formulation itself could person had mild protective effects by stabilizing nan nasal barrier.
The study was funded by Ursapharm Arzneimittel GmbH, nan shaper of azelastine nasal spray, and conducted successful collaboration pinch Saarland University researchers. Despite these promising findings, larger tests must beryllium conducted to validate these observations and research nan imaginable inferior of azelastine for different respiratory viruses.
Journal reference:
- Lehr, T., Meiser, P., Selzer, D., et al. (2025). Azelastine Nasal Spray for Prevention of SARS-CoV-2 Infections: A Phase 2 Randomized Clinical Trial. JAMA Internal Medicine. doi:10.1001/jamainternmed.2025.4283.
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