#18,866
Unless and until the CDC's ACIP makes a ruling on the availability of the COVID vaccine, tens of millions of Americans (including seniors, like myself) are finding it difficult (or, in some states, impossible) to get a COVID shot without a doctor's prescription (see map above).
Even with a prescription, some pharmacies are unwilling to provide shots until a decision is rendered by the CDC. Which, as we go into the fall respiratory season, puts a lot of people at greater risk of infection.
There are other options, of course. I continue to wear an N95/KN95 mask in crowded indoor environments, since the COVID vaccine only provides partial protection. I've now gone 4+ years without so much as a sniffle, and I'll continue to do so for the foreseeable future.
But there have been some intriguing studies suggesting that some types of OTC medications may be an adjunct to help prevent COVID and other respiratory infections (see The Lancet Resp. Med.: Nasal sprays & Behavioural Interventions Reduced Infections & Improved Recovery Times).
Many of these studies have been in vitro, or have been observational in nature (see PNAS Intranasal neomycin evokes broad-spectrum antiviral immunity in the upper respiratory tract), but last week JAMA Int. Medicine published a fascinating (albeit, modest) randomized placebo-controlled clinical trial which showed encouraging results from an Azelastine nasal spray against COVID infection.
As always, none of what follows is medical advice, and is provided for educational purposes only. If you find merit in these findings, and wish to pursue them, consult your physician.
In short, they divided a study cohort of 450 subjects into 2 (roughly equal) groups; a control arm which took a placebo and an arm which took a 0.1%, Azelastine nasal spray 3 times a day for 56 days.
At the end of the study those taking the active ingredient saw a 67% reduction in PCR confirmed COVID infection. Note: there were some (mostly mild) AEs (adverse effects) reported in both groups.
I've posted the abstract below. Follow the link to read the research paper in full. After which I'll have more for your consideration.
Azelastine Nasal Spray for Prevention of SARS-CoV-2 InfectionsA Phase 2 Randomized Clinical Trial
Thorsten Lehr, PhD1; Peter Meiser, PhD2; Dominik Selzer, PhD1
JAMA Intern Med
Published Online: September 2, 2025
doi: 10.1001/jamainternmed.2025.4283
Key Points
Question Is regular application of azelastine nasal spray associated with reduced risk of SARS-CoV-2 infections?
Findings In this randomized placebo-controlled clinical trial that included 450 participants, the incidence of laboratory-confirmed SARS-CoV-2 infections was significantly lower with application of azelastine nasal spray compared with placebo treatment.
Meaning The use of azelastine nasal spray may help to reduce the risk of SARS-CoV-2 infections.Abstract
Importance Limited pharmaceutical options exist for preexposure prophylaxis of COVID-19 beyond vaccination. Azelastine, an antihistamine nasal spray used for decades to treat allergic rhinitis, has in vitro antiviral activity against respiratory viruses, including SARS-CoV-2.
Objective To determine the efficacy and safety of azelastine nasal spray for prevention of SARS-CoV-2 infections in healthy adults.
Design, Setting, and Participants A phase 2, double-blind, placebo-controlled, single-center trial was conducted from March 2023 to July 2024. Healthy adults from the general population were enrolled at the Saarland University Hospital in Germany.
Interventions Participants were randomly assigned 1:1 to receive azelastine, 0.1%, nasal spray or placebo 3 times daily for 56 days. SARS-CoV-2 rapid antigen testing (RAT) was conducted twice weekly, with positive results confirmed by polymerase chain reaction (PCR). Symptomatic participants with negative RAT results underwent multiplex PCR testing for respiratory viruses.
Main Outcome The primary end point was the number of PCR-confirmed SARS-CoV-2 infections during the study.
Results A total of 450 participants were randomized, with 227 assigned to azelastine and 223 to placebo; 299 (66.4%) were female, 151 (33.6%) male, with a mean (SD) age of 33.0 (13.3) years. Most were White (417 [92.7%]), with 4 (0.9%) African, 22 (4.9%) Asian, and 7 (1.6%) of other ethnicity. In the intention-to-treat (ITT) population, the incidence of PCR-confirmed SARS-CoV-2 infection was significantly lower in the azelastine group (n = 5 [2.2%]) compared with the placebo group (n = 15 [6.7%]) (OR, 0.31; 95% CI, 0.11-0.87).
As secondary end points, azelastine demonstrated an increase in mean (SD) time to SARS-CoV-2 infection among infected participants (31.2 [9.3] vs 19.5 [14.8] days), a reduction of the overall number of PCR-confirmed symptomatic infections (21 of 227 participants vs 49 of 223 participants), and a lower incidence of PCR-confirmed rhinovirus infections (1.8% vs 6.3%). Adverse events were comparable between the groups.
Conclusions and Relevance In this single-center trial, azelastine nasal spray was associated with reduced risk of SARS-CoV-2 respiratory infections. These findings support the potential of azelastine as a safe prophylactic approach warranting confirmation in larger, multicentric trials.
Trial registration EudraCT number: 2022-003756-13
While this study used an Rx 0.1%, Azelastine nasal spray, in 2021 a more potent 0.15% formulation was approved for OTC sale in the United States.
While a 67% reduction in infection is impressive, this study followed a relatively small cohort, was conducted in a single location, and against a (likely) limited number of variants.For more detailed analysis by a physician, I'd highly recommend spending 20 minutes watching the following MedCram Youtube video by Dr. Roger Seheult, MD.
As we go into the fall respiratory season, I'll be getting the flu shot - and with luck, a COVID shot - in the next few weeks. But I'll also continue to wear my facemask in crowded venue, and may add the Azelastine spray to my arsenal.
While it's a hassle - because of my age (71) and accrued co-morbidities - I find the risks of COVID reinfection (see partial list below), along with the dangers of flu, RSV, and other winter nasties to be enough to warrant these extra precautions on my part.As always, YMMV.
EHJ: Accelerated Vascular Ageing After COVID-19 Infection: The CARTESIAN Study
AHA: COVID-19 May Trigger New-Onset High Blood Pressure
JAMA: Additional Evidence Of A Post-COVID/Diabetes Link