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Background:  Inhaled budesonide benefits patients with COVID-19.  ProLung™-budesonide  enables the sustained, low dose administration of budesonide within a delivery vehicle similar to lung surfactant.  ProLung™-budesonide  may offer anti-inflammatory and protective effects to the lung in COVID-19, yet it’s effect on SARS-CoV-2 replication is unknown.    Objective:  To determine the efficacy of  ProLung™-budesonide  against SARS-CoV-2-infection  in vitro , evaluate its ability to decrease inflammation, and airway hyperresponsiveness in an animal model of lung inflammation.    Methods:  SARS-CoV-2-infected Vero 76 cells were treated with  ProLung™-budesonide  ([0.03–100 µg/ml]) for 3 days, and virus yield in the supernatant was measured. Ovalbumin-sensitized C57BL/6 mice received aerosolized (a)  ProLung™-budesonide  weekly, (b) only budesonide, either daily or weekly, or (c) weekly empty  ProLung™ carrier  (without budesonide). All treatment groups were compared to sensitized untreated, or normal mice using histopathologic examination, electron microscopy (EM), airway hyperresponsiveness (AHR) to Methacholine (Mch) challenge, and eosinophil peroxidase activity (EPO) measurements in bronchioalveolar lavage (BAL).    Results:   ProLung™-budesonide  showed significant inhibition of viral replication of SARS-CoV-2-infected cells with the selectivity index (SI) value >24. Weekly  ProLung™-budesonide  and daily budesonide therapy significantly decreased lung inflammation and EPO in BAL.  ProLung™-budesonide  localized in type II pneumocytes, and was the only group to significantly decrease AHR, and EPO in BAL with Mch challenge    Conclusions:   ProLung™-budesonide  significantly inhibited viral replication in SARS-CoV-2-infected cells. It localized into type II pneumocytes, decreased lung inflammation, AHR and EPO activity with Mch challenge. This novel drug formulation may offer a potential inhalational treatment for COVID-19.

ProLung™-budesonide Inhibits SARS-CoV-2 Replication and Reduces Lung Inflammation