Nasal spray treating COVID-19
Image credits: Chat GPT
Azelastine nasal spray was associated with a significantly reduced risk of laboratory-confirmed SARS-CoV-2 infections in a phase 2 randomized clinical trial published September 2, 2025, in JAMA Internal Medicine. Investigators reported that the spray reduced SARS-CoV-2 respiratory infections and may serve as a safe prophylactic intervention, though confirmation in larger multicenter trials is needed.1
The double-blind, placebo-controlled, single-center study enrolled 450 healthy adults at Saarland University Hospital in Germany between March 2023 and July 2024. Participants were randomized 1:1 to receive azelastine, .1%, nasal spray (n = 227) or placebo (n = 223), administered 3 times daily for 56 days. Twice-weekly SARS-CoV-2 rapid antigen testing was conducted, with positive results confirmed by polymerase chain reaction (PCR). Symptomatic participants with negative rapid antigen tests underwent multiplex PCR for respiratory viruses.1
In the intention-to-treat analysis, the incidence of PCR-confirmed SARS-CoV-2 infection was significantly lower in the azelastine group (5 of 227 (2.2%) compared with placebo (15 of 223 (6.7%) (odds ratio, .31; 95% CI, .11-.87). The mean (SD) time to SARS-CoV-2 infection among infected participants was longer with azelastine than placebo (31.2 [9.3] vs 19.5 [14.8] days). Azelastine also reduced PCR-confirmed symptomatic infections (21 vs 49) and lowered incidence of PCR-confirmed rhinovirus infection (1.8% vs 6.3%).1
What You Need To Know
In the intention-to-treat analysis, SARS-CoV-2 infections occurred in 2.2% of the azelastine group vs 6.7% of placebo (OR, .31; 95% CI, .11-.87).
Azelastine use was linked to a longer mean time to infection (31.2 vs 19.5 days) and fewer PCR-confirmed symptomatic infections (21 vs 49).
The spray also reduced rhinovirus infections (1.8% vs 6.3%), with adverse events comparable between groups.
According to investigators, “the increase in time to SARS-CoV-2 infection indicates that even in times of higher exposure rates, fewer infections per exposure occurred under treatment compared with placebo. Together, these findings reinforce the potential of azelastine nasal spray to meaningfully reduce infection risk in a prophylactic setting.”1
Baseline demographics showed a mean (SD) age of 33.0 (13.3) years; 66.4% of participants were female, and 92.7% were White. Adverse events occurred at similar rates between groups.1
The study’s limitations included its modest sample size, single-center design, and a largely healthy, vaccinated population, which may restrict generalizability. Additional concerns were potential unblinding due to azelastine’s bitter taste, possible prophylactic effects of the placebo, and underreporting of asymptomatic or non–SARS-CoV-2 infections due to testing protocols.1
According to the Mayo Clinic, azelastine nasal spray is an FDA-approved antihistamine used for seasonal and perennial allergic rhinitis and other upper respiratory allergies. By blocking histamine, it helps relieve nasal congestion, sneezing, itching, and runny nose. The drug has been available for decades, is generally well tolerated, and is now being investigated for potential antiviral benefits, including activity against SARS-CoV-2.2