COVID-19: Azelastine nasal spray Reduces Virus-load In Nasal swabs (CARVIN) Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients – results from a randomized, double-blind, placebo-controlled phase II clinical trial.

Abstract

COVID-19 strongly influences our daily lives, and there is urgent need for a therapy treating early infections to prevent progression.CARVIN was a randomized, parallel, double-blind, placebo-controlled study. 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

Pharmacometric Modeling of the Impact of Azelastine Nasal Spray on SARS-CoV-2 Viral Load and Related Symptoms in COVID-19 Patients

“…To analyze the impact of azelastine on viral load and COVID-19 symptoms, clinical data from the double-blind CARVIN study were used [ 5 ]. Here, 90 COVID-19 patients were included that were recently tested positive for SARS-CoV-2 not requiring hospitalization nor being at risk for severe disease.…”

“…For an individual score of the disease severity, the sum of symptom scores was used as the outcome measure (symptom sum score). Further details of the study are published elsewhere [ 5 ].…”

“…Recently, the CARVIN study was performed to evaluate the effect of azelastine nasal spray on the SARS-CoV-2 viral load and infection-related symptoms in SARS-CoV-2 positive patients with mild symptoms who do not require inpatient treatment [ 5 ]. In this double-blind study, patients received either placebo, 0.02 or 0.1% azelastine nasal spray three times daily for 11 days of treatment.…”

“…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 18.5 and 21.4% in the 0.1 and 0.02% groups, respectively, compared to 0% for placebo on day 8 [ 5 ].…”