Bovhyaluronidase azoximer for long-term pulmonary sequelae of COVID19: a multicenter, randomized, double-blind, placebo-controlled study

Abstract

Background: Bovhyaluronidase azoximer (BA) has been reported to improve pulmonary function and exercise tolerance in patients with pulmonary sequelae of COVID-19. In this multicenter, randomized, double-blind, placebo-controlled study, we evaluated the effects of BA on patients with long-term (up to 12 months) pulmonary sequelae of COVID-19. Methods: Patients (n = 392) were randomized 1:1 to receive BA or placebo every 5 days for 71 days. Percent predicted forced vital capacity (ppFVC), respiratory symptoms, and exercise tolerance indicators were assessed at baseline and on Days 71 (Δ ppFVC was the primary endpoint) and 180. Results: The pre-specified primary endpoint (Δ ppFVC at Day 71) was negative (+0.30%, p = 0.817). Secondary endpoints showed reduced exertional desaturation (OR 0.36, p = 0.006) and dyspnea (OR 0.62, p = 0.040). Conclusion: While the primary objective yielded clinically insignificant results, patients treated with BA showed increased exercise tolerance although further investigations are required to confirm findings. Trial registration: The study is registered at ClinicalTrials.gov (NCT06383819).