NCT05386420

A Safety and Efficacy Study of Hymecromone Tablets for the Treatment of Patients With COVID-19.

A Single-center, Randomized, Parallel Controlled, Double-blind Clinical Trial Designed to Evaluate the Efficacy and Safety of Hymecromone Tablets in Subjects Diagnosed With COVID-19 Infection.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019, which causes epidemic worldwide. A study found that the increase in hyaluronic acid levels is closely related to the clinical symptoms of COVID-19, including pulmonary ground glass lesions, lymphocytopenia, immune response and cytokine storms, systemic vascular diseases, thrombotic coagulation disorders, which suggests that hyaluronic acid could be an important target for COVID-19 treatment and could improve the clinical symptoms of COVID-19 patients. The results from a recent clinical trial recruited 144 patients with COVID-19 show that the inhibitor of hyaluronic acid synthesis, hymecromone, can significantly improve clinical symptoms, such as lung lesions and lymphocytopenia in COVID-19 patients. Therefore, hymecromone has the potential to become one of the options of COVID-19 treatment. This study is a single-center, randomized, parallel controlled, double-blind clinical trial designed to evaluate the efficacy and safety of Hymecromone tablets in subjects aged 18-90 years (with boundary values) with a confirmed mild or moderate form of COVID-19 infection. The aim of this study is to optimize the program of the combination of hymecromone in the treatment of COVID-19 to improve the therapeutic effect.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Hymecromone tablets	Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.
OTHER	Placebo	Conventional treatment combined with Placebo.

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-08-15
• Completion: 2022-11-15
• First posted: 2022-05-23
• Last updated: 2022-06-09

Locations

1 site across 1 country: China