Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients

Abstract

With the changing epidemiology of COVID-19 and its impact on our daily lives, there is still an unmet need of COVID-19 therapies treating early infections to prevent progression. The current study was a randomized, parallel, double-blind, placebo-controlled trial. Ninety SARS-CoV-2 positive patients were randomized into 3 groups receiving placebo, 0.02% or 0.1% azelastine nasal spray for 11 days, during which viral loads were assessed by quantitative PCR. Investigators assessed patients’ status throughout the trial including safety follow-ups (days 16 and 60). Symptoms were documented in patient diaries. Initial viral loads were log10 6.85 ± 1.31 (mean ± SD) copies/mL (ORF 1a/b gene). After treatment, virus load was reduced in all groups (p < 0.0001) but was greater in the 0.1% group compared to placebo (p = 0.007). In a subset of patients (initial Ct < 25) viral load was strongly reduced on day 4 in the 0.1% group compared to placebo (p = 0.005). Negative PCR results appeared earlier and more frequently in the azelastine treated groups: being 18.52% and 21.43% in the 0.1% and 0.02% groups, respectively, compared to 0% for placebo on day 8. Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. The shown effects of azelastine nasal spray may thus be suggestive of azelastine’s potential as an antiviral treatment.Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). EudraCT number: 2020-005544-34.

COVID-19 in relation to chronic antihistamine prescription

“…However, the current study did not include azithromycin treatment for patients admitted to the Terrassa Hospital, precluding assessment of the role of combined prescriptions. Despite this, the protective effect of antihistamines is suggested by our results, which is also consistent with other reports in vitro [20] and after nasal administration [21].…”

Antiviral Potential of Azelastine against Major Respiratory Viruses

“…We previously demonstrated the efficacy of azelastine-HCl and a commercial nasal spray containing azelastine-HCl against major variants of SARS-CoV-2 in vitro [18]. The in vivo effectiveness of the azelastine-containing nasal spray was confirmed by a subsequent clinical trial [11]. Here, we show the activity of azelastine-HCl against the omicron BA.1 variant that emerged later during the SARS-CoV-2 pandemic in both co-administration and a therapeutic setting.…”

“…It was previously shown, using in silico methods, that the approved drug azelastine-HCl has antiviral activity. Azelastine-HCL inhibited SARS-CoV-2 replication in in vitro assays, and a clinical study with a commercially available nasal spray containing azelastine-HCl demonstrated a reduction in the viral load of SARS-CoV-2 in the nasopharynx [11]. Here, we provide in vitro evidence for the antiviral activity of azelastine-HCl against unrelated common respiratory viruses.…”

“…Additionally, there are clinical data that support our findings. We have shown in a phase 2 clinical study that the use of an azelastinecontaining nasal spray reduced the viral load and shortened the viral carriage in the upper respiratory tract of SARS-CoV-2-infected individuals [11]. An earlier publication also showed the effect of the prophylactic use of an azelastine nasal spray to prevent upper respiratory tract infections in children [40].…”

“…Alternatively, the commercially available azelastine-HCl nasal spray Pollival ® (URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany) was used. The buffer of Pollival ® was provided by the manufacturer (URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany) and was identical to the placebo used in clinical trials by the company [11].…”