Efficacy and safety of the hyaluronic acid inhibitor Hymecromone for the treatment of COVID-19: study protocol for a single-centre, randomized, controlled, Double-blind Clinical trial (preprint)

ABSTRACT

IntroductionHyaluronic acid (HA) is one of the main components of glycosaminoglycan (GAG) in proteoglycans. Among patients with novel coronavirus pneumonia, the serum HA content of severe patients was significantly higher than that of mild patients. Therefore, hyaluronic acid inhibitors have the potential to be the treatment of novel coronavirus pneumonia. This study plans to carry out a study on the optimization of the hyaluronic acid inhibitor Hymecromone in the treatment of COVID-19 to improve the therapeutic effect.Methods and analysisThis is a single-center, randomized, parallel controlled, double-blind clinical trial designed to evaluate the efficacy and safety of hymecromone tablets in subjects who confirmed to be infected by the SARS-CoV-2 virus and diagnosed as mild or moderate novel coronavirus pneumonia in China. The subjects in the experimental arm shall receive necessary routine treatment and hymecromone tablets while the control arm shall receive placebo. The study aims to compare the proportion of subjects in the experimental group and the control group who developed disease progression within 28 days after initial treatment. Meanwhile, all subjects will be monitored for safety constantly during the whole study phases.Ethics and disseminationThe study protocol was approved by the Ethics Committee of Zhongshan Hospital Fudan University (identifiers Clinical Ethical Approval No. B2022-251R).Trial registrationClinicalTrails.org, NCT05386420. Registered 24 May 2022, https//clinicaltrials.gov/ct2/show/NCT05386420Strengths and limitations of this studyThis is one of the first prospective randomized controlled double-blind studies of the efficacy and safety of the hyaluronic acid inhibitor Hymecromone for the treatment of COVID-19. This study will be an innovative clinical intervention strategy, and is expected to provide an effective new treatment plan for the clinical treatment of severe infection with COVID-19. The limitation is it is a single center study, it might need more centers cases to be further external validated.INTRODUCTION: