ABSTRACT
Background: Breathox is a sodium chloride inhaler. Increase of the airway salinity has been proposed to reduce the symptomatic stage of a respiratory viral infection. Objective(s): to evaluate the effectiveness of nasal and inhaled sodium chloride therapy through Breathox on mild COVID-19 symptoms in patients >= 18 years-old compared to usual care. Method(s): a pilot, open, randomized clinical trial, including 100 patients with confirmed and symptomatic COVID-19 within 10 days of symptom onset. All patients received standard of care (SOC), i.e. antipyretic or analgesic. Breathox was administered as two oral inhalations and one nasal instillation in each nostril at each administration with 2mg per inhalation. Patients were randomized 1:1:1 into three groups: Group 1(G1): SOC + Breathox 10 times daily for 10 days;Group 2(G2): SOC + Breathox five times daily for 10 days;Group 3(G3): SOC. Recovery time for symptoms, such as cough was assessed. Result(s): In total 100 of 103 screened patients were included from December 1 2021 to March 03 2022. Of those, 33 from G1 and G3, and 32 from G2 completed the study. Mean age was 40.4/42.2/40.6 years old for G1, G2 and G3, (p=0.96). No patients were hospitalized or died during the study. Time to cough resolution was reduced in G1 (2.8+/-0.66 days) and G2 (2.4+/-0.66 days) compared to G3 (5.39+/-0.79 days) (p=0.001), with a hazard ratio (HR) for G2 of 2.17 (Confidence interval 1.17-4.04) and G3 of 2.01 (1.06-3.81) compared to SOC. Conclusion(s): ten days of Breathox use halved the time for resolution of COVID-19-induced cough.