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Status unknownNCT05386420Updated Jun 9, 2022

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

An interventional study of Hymecromone tablets and Placebo in COVID-19, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
304
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19

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Keywords

  • COVID-19
  • Hymecromone
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 304 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
304 participants (estimated)

Study arms

  • Experimental
    Experimental group

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

    Drug: Hymecromone tablets

  • Placebo comparator
    Control group

    Conventional treatment combined with placebo.

    Other: Placebo

Interventions

  • DrugHymecromone tablets

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

  • OtherPlacebo

    Conventional treatment combined with Placebo.

06

What researchers measure

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.

    Time frame: Within 28 days after initial treatment.

Secondary outcomes

  1. 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.

    Time frame: The whole test process.

  2. 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.

    Time frame: From the beginning of the research to the negative report of COVID-19 nucleic acid.

  3. 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.

    Time frame: From the beginning of the research to the disappearance of clinical symptoms.

  4. 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.

    Time frame: Between baseline and the end of study observation.

07

Study locations

1 of 1 sites recruiting
  • Zhong Shan Hospital affiliated to Fudan University
    Shanghai, Shanghai 200030, China
    • Hao Fang, M.D. · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35304437 ↗
  • 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. PubMed 35124429 ↗
  • 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. PubMed 25852691 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05386420
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Hao Fang (Chief physician, Vice President, Shanghai Zhongshan Hospital) — Principal investigator
First posted
May 23, 2022
Start date
May 23, 2022
Primary completion
Aug 15, 2022 (estimated)
Completion
Nov 15, 2022 (estimated)
Last update
Jun 9, 2022

Study contacts

Hao Fang
Contact
fang.hao@zs-hospital.sh.cn
+86 21-64041990
Hao Fang
principal investigator · Zhong Shan Hospital affiliated to Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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