Azelastine Nasal Spray for Prevention of SARS-CoV-2 Infections

作者：Thorsten Lehr, Peter Meiser, Dominik Selzer, Torben Rixecker, Frank Holzer, Ralph Mösges, Sigrun Smola, Robert Bals, CONTAIN Study Group, Veronika Alberg, Florian Bub, Nicholas Biwank, Charlotte Maria Ursula Dette, Lale Dastgir, Aaron Kuntz, Christopher Hale, J. Kapp, Kathrin Litzenburger, Henning Morr, Johanna Wagner, Hacer Sahin, Nelli Schröder, Martina Seibert, Katrin Thieser, Quirin Werthner · 发表于：JAMA Internal Medicine · 年份：2025 · DOI：10.1001/jamainternmed.2025.4283 · 被引用次数：7 · 研究领域：Respiratory viral infections research、Olfactory and Sensory Function Studies、Allergic Rhinitis and Sensitization

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 o...