a safety and efficacy study of hymecromone tablets for the treatment of patients with covid-19.

Conditions: COVID-19

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.


Eligibility criteria:
inclusion criteria: 1. participants who have a positive sars-cov-2 test result ; 2. participants who have been diagnosed with mild or ordinary type of covid-19 infection; 3. participants whose serum hyaluronic acid level was higher than the upper limit of normal value; 4. participants who must agree to adhere to contraception restrictions; 5. participants who understand and agree to comply with planned study procedures; 6. participants who give signed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: 1. participants who have any of the following conditions when screening: 1. alt or ast \> 5 uln; 2. scr \> 1.5 uln or ccr \< 50 ml/min; 3. tbil \> 2uln ; 4. hgb ≤ 90 g/ l; 5. plt ≤ 75×10\^9/ l; 2. participants who have suspected/active infections during the screening period including uncontrolled active bacterial, viral or fungal infections that require systemic treatment, except covid-19 virus infections; 3. participants who have any active autoimmune diseases during the screening period and need to be treated with immunosuppressants, including biological agents; 4. participants who have a medical history of organ transplantation, or plan for organ transplantation including liver transplantation; 5. participants who need a loading dose of anti-platelet drugs, such as aspirin (\>300 mg/day) and clopidogrel (\>300 mg/day); 6. participants who have a medical history of central nervous system and digestive system bleeding, or a tendency of gastrointestinal bleeding, local active ulcer lesions included, in the last three months; 7. participants who have biliary obstruction; 8. female participants who are pregnant or breast-feeding or plan to be pregnant within this study period; 9. male participants whose wife or partner plan to be pregnant within this study period. 10. participants who have taken the drugs containing coumarin compounds, such as warfarin, within 3 days before screening; 11. participants who have other diseases requiring hospitalization and/or in a need of surgical treatment within 7 days before screening, or have suffered from life-threatening diseases within 30 days before screening; 12. participants who have known allergies to any of the components used in the formulation of the interventions; 13. participants who have taken a part in a clinical study of an investigational intervention in the last 28 days. after 5 half-lives or 28 days, whichever is longer, can be allowed for screening; 14. participants who are not suitable for this trial, and with any medical condition will compromise their own safety.

Keywords: covid-19 hymecromone