COVID-19NCT05386420
A Safety and Efficacy Study of Hymecromone Tablets for the Treatment of Patients With COVID-19.
A study testing Hymecromone tablets in people with COVID-19, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Hymecromone tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhong Shan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200030
Hao Fang, M.D.
About this study
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.
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
- Being tested
- Hymecromone tablets, Placebo
- Keywords
- COVID-19, Hymecromone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hymecromone tabletsDrug
Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days.
PlaceboOther
Conventional treatment combined with Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Conventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days. Receives: Drug: Hymecromone tablets |
| Control group | Placebo comparator | Conventional treatment combined with placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 28 days after initial treatment.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between baseline and the end of study observation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start23 May 2022
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Fang, Shanghai Zhongshan Hospital
- Investigators
- Hao Fang, Principal investigator, Zhong Shan Hospital affiliated to Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386420
- Sponsor's protocol ID
- QJXDS-22-01
- Status last verified
- Jun 2022
- First submitted
- 20 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35304437Li 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 35124429Nagy 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 25852691Salman 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.
PubMed 37055910
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05386420
- Acronym / sponsor ID
- QJXDS-22-01
- Conditions
- COVID-19
- Keywords
- COVID-19, Hymecromone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Hymecromone tabletsConventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days. |
| Control group | Placebo comparator | Other: PlaceboConventional treatment combined with placebo. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (19 listed)
- Participants who have any of the following conditions when screening:
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hymecromone tabletsConventional treatment combined with Hymecromone tablets, 0.4g , tid ac, 7 days. | Drug | Experimental group |
| PlaceboConventional treatment combined with Placebo. | Other | Control group |
Primary outcome
The proportion of subjects who developed disease progression.
Time frame: Within 28 days after initial treatment.
To compare the proportion of subjects in the experimental group and the control group who developed disease progression within 28 days after initial treatment.
4 secondary outcomes
The incidence of adverse events and serious adverse events.
Time frame: The whole test process.
The time gap of COVID-19 virus clearance.
Time frame: 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.
Time frame: From the beginning of the research to the disappearance of clinical symptoms.
The change of the serum hyaluronic acid.
Time frame: Between baseline and the end of study observation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Background: PubMed 35304437Yang 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.
- Background: PubMed 35124429Li 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.
- Background: PubMed 25852691Nagy 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.
- Derived from this study: PubMed 37055910Salman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Fang principal investigator
Zhong Shan Hospital affiliated to Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hymecromone tablets in people with COVID-19, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Fang (+86 21-64041990, fang.hao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who developed disease progression. (time frame: Within 28 days after initial treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386420, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.