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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Hymecromone tablets
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have a positive SARS-CoV-2 test result ; Participants who have been diagnosed with mild or ordinary type of COVID-19 infection; Participants whose serum hyaluronic acid level was higher than the upper limit of normal value; Participants who must agree to adhere to contraception restrictions; Participants who understand and agree to comply with planned study procedures; 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: Participants who have any of the following conditions when screening: ALT or AST > 5 ULN; Scr > 1.5 ULN or Ccr < 50 mL/min; TBIL > 2ULN ; HGB ≤ 90 g/ L; PLT ≤ 75×10^9/ L; 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; Participants who have any active autoimmune diseases during the screening period and need to be treated with immunosuppressants, including biological agents; Participants who have a medical history of organ transplantation, or plan for organ transplantation including liver transplantation; Participants who need a loading dose of anti-platelet drugs, such as aspirin (>300 mg/day) and clopidogrel (>300 mg/day); 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; Participants who have biliary obstruction; Female participants who are pregnant or breast-feeding or plan to be pregnant within this study period; Male participants whose wife or partner plan to be pregnant within this study period. Participants who have taken the drugs containing coumarin compounds, such as warfarin, within 3 days before screening; 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; Participants who have known allergies to any of the components used in the formulation of the interventions; 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; Participants who are not suitable for this trial, and with any medical condition will compromise their own safety.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days. | Drug: Hymecromone tablets<br>* Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.<br>|
| Placebo Comparator: Control group<br>Conventional treatment combined with placebo. | Other: Placebo<br>* Conventional treatment combined with Placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who developed disease progression. | To compare the proportion of subjects in the experimental group and the control group who developed disease progression within 28 days after initial treatment. | Within 28 days after initial treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events and serious adverse events. | To compare the incidence of adverse events and serious adverse events related to the study treatment in the experimental group and the control group. | The whole test process. | 
| The time gap of COVID-19 virus clearance. | To compare the time of virus clearance by COVID-19 virus tests in the experimental group and the control group. | From the beginning of the research to the negative report of COVID-19 nucleic acid. | 
| The clinical recovery time of the COVID-19 virus infection-related symptoms. | To compare the clinical recovery time of the COVID-19 virus infection-related symptoms in the experimental group with the control group. | From the beginning of the research to the disappearance of clinical symptoms. | 
| The change of the serum hyaluronic acid. | To compare the serum hyaluronic acid level between baseline and the end of study observation of all subjects in the experimental group and the control group. | Between baseline and the end of study observation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Hymecromone