Back to resultsA Safety and Efficacy Study of Hymecromone Tablets for the Treatment of Patients With COVID-19.
Primary Purpose
COVID-19
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hymecromone tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Hymecromone
Eligibility Criteria
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.
Sites / Locations
- Zhong Shan Hospital affiliated to Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.
Conventional treatment combined with placebo.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05386420
Brief Title
A Safety and Efficacy Study of Hymecromone Tablets for the Treatment of Patients With COVID-19.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Hymecromone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
304 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Conventional treatment combined with placebo.
Intervention Type
Drug
Intervention Name(s)
Hymecromone tablets
Intervention Description
Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Conventional treatment combined with Placebo.
Primary Outcome Measure Information:
Title
The proportion of subjects who developed disease progression.
Description
To compare the proportion of subjects in the experimental group and the control group who developed disease progression within 28 days after initial treatment.
Time Frame
Within 28 days after initial treatment.
Secondary Outcome Measure Information:
Title
The incidence of adverse events and serious adverse events.
Description
To compare the incidence of adverse events and serious adverse events related to the study treatment in the experimental group and the control group.
Time Frame
The whole test process.
Title
The time gap of COVID-19 virus clearance.
Description
To compare the time of virus clearance by COVID-19 virus tests in the experimental group and the control group.
Time Frame
From the beginning of the research to the negative report of COVID-19 nucleic acid.
Title
The clinical recovery time of the COVID-19 virus infection-related symptoms.
Description
To compare the clinical recovery time of the COVID-19 virus infection-related symptoms in the experimental group with the control group.
Time Frame
From the beginning of the research to the disappearance of clinical symptoms.
Title
The change of the serum hyaluronic acid.
Description
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.
Time Frame
Between baseline and the end of study observation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Fang
Phone
+86 21-64041990
Email
fang.hao@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Fang
Organizational Affiliation
Zhong Shan Hospital affiliated to Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhong Shan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Fang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35304437
Citation
Yang S, Ling Y, Zhao F, Li W, Song Z, Wang L, Li Q, Liu M, Tong Y, Chen L, Ru D, Zhang T, Zhou K, Zhang B, Xu P, Yang Z, Li W, Song Y, Xu J, Zhu T, Shan F, Yu W, Lu H. Hymecromone: a clinical prescription hyaluronan inhibitor for efficiently blocking COVID-19 progression. Signal Transduct Target Ther. 2022 Mar 18;7(1):91. doi: 10.1038/s41392-022-00952-w.
Results Reference
background
PubMed Identifier
35124429
Citation
Li W, Yang S, Xu P, Zhang D, Tong Y, Chen L, Jia B, Li A, Lian C, Ru D, Zhang B, Liu M, Chen C, Fu W, Yuan S, Gu C, Wang L, Li W, Liang Y, Yang Z, Ren X, Wang S, Zhang X, Song Y, Xie Y, Lu H, Xu J, Wang H, Yu W. SARS-CoV-2 RNA elements share human sequence identity and upregulate hyaluronan via NamiRNA-enhancer network. EBioMedicine. 2022 Feb;76:103861. doi: 10.1016/j.ebiom.2022.103861. Epub 2022 Feb 3.
Results Reference
background
PubMed Identifier
25852691
Citation
Nagy N, Kuipers HF, Frymoyer AR, Ishak HD, Bollyky JB, Wight TN, Bollyky PL. 4-methylumbelliferone treatment and hyaluronan inhibition as a therapeutic strategy in inflammation, autoimmunity, and cancer. Front Immunol. 2015 Mar 23;6:123. doi: 10.3389/fimmu.2015.00123. eCollection 2015.
Results Reference
background
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A Safety and Efficacy Study of Hymecromone Tablets for the Treatment of Patients With COVID-19.
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