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

NCT05386420 | Unknown DMC

• 1 other identifier: QJXDS-22-01
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Hymecromone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The incidence of adverse events and serious adverse events.

  The whole test process.

• The time gap of COVID-19 virus clearance.

  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.

  From the beginning of the research to the disappearance of clinical symptoms.

• The change of the serum hyaluronic acid.

  Between baseline and the end of study observation.

Study Arms (2)

Experimental group

EXPERIMENTAL

Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.

Drug: Hymecromone tablets

Control group

PLACEBO COMPARATOR

Conventional treatment combined with placebo.

Other: Placebo

Interventions

Hymecromone tablets DRUG

Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.

Experimental group

Placebo OTHER

Conventional treatment combined with Placebo.

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhong Shan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 35304437 BACKGROUND

• 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.

  PMID: 35124429 BACKGROUND

• 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.

  PMID: 25852691 BACKGROUND

• Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14.

  PMID: 37055910 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hymecromone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Umbelliferones; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hao Fang

  Zhong Shan Hospital affiliated to Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Fang

CONTACT

+86 21-64041990; fang.hao@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Vice President

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 23, 2022
• Study Start: May 23, 2022
• Primary Completion: August 15, 2022
• Study Completion: November 15, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)