A Safety and Efficacy Study of Hymecromone Tablets for the Treatment of Patients With COVID-19.
NCT05386420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304
Last updated 2022-06-09
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
Interventions
- DRUG
-
Hymecromone tablets
Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.
- OTHER
-
Placebo
Conventional treatment combined with Placebo.
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
lead OTHER
Principal Investigators
-
Hao Fang · Zhong Shan Hospital affiliated to Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-23
- Primary Completion
- 2022-08-15
- Completion
- 2022-11-15
Countries
- China
Study Locations
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