COVID-19NCT05713279
Study of Flonoltinib Maleate Tablets in the Treatment of Severe Novel Coronavirus (COVID-19) Infection
A study testing SOC in people with COVID-19, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
Flonoltinib Maleate (FM) is a triple-target inhibitor of JAK2, FLT3, and CDK6. It inhibited JAK2 with an IC50 of 0.8 nM, whereas its IC50 values against JAK1, JAK3, and TYK2 were 690 nM, 557 nM, and 65 nM, respectively, indicating high selectivity for JAK2 over other JAK family kinases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- SOC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2023to 30 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 18 years old, gender is not limited;
- COVID-19 infection inclusion criteria: hospitalized with coronavirus (COVID-19) within 14 days, samples collected 72 hours before enrollment confirmed by polymerase chain reaction (PCR) test or antigen test (if due to lack of testing supplies, testing capacity and conditions are limited, but indicate a progressive disease with persistent infection with COVID-19), the investigator judged that the condition was aggravated, and any of the following criteria were met as severe COVID-19 patients:
- Respiratory distress, respiratory rate≥ 30 times/min; At rest, oxygen saturation ≤ 93% when inhaling air; Arterial partial pressure of oxygen (PaO2)/oxygen inhalation concentration (FiO2)≤ 300 mmHg; Clinical symptoms are progressively aggravated, lung imaging shows that the lesions within 24~48h have progressed significantly > 50%.
- Adults with any of the following are defined as critically ill with COVID-19: respiratory failure requiring mechanical ventilation; Appearance of shock; Other organ failure requires ICU monitoring; Severe and critical cases of novel coronavirus infection, collectively referred to as "severe cases". Severe cases can also be managed as severe cases if pneumonia caused by novel coronavirus infection does not meet the diagnostic criteria for severe cases: age > 65 years old, incomplete full vaccination, and more serious chronic diseases (including hypertension, diabetes, coronary heart disease, chronic lung disease, malignant tumors, and immunocompromise, etc.)
- Patients with risk of progression before enrollment: at least one inflammatory index greater than the upper limit of normal (IL-6, CRP, d-dimer, LDH, ferritin≥ULN) within 2 days;
- willing and/or able to comply with research-related procedures and assessments;
- Those who can understand and agree to participate in this research and sign the informed consent form;
Who cannot join
- Known or suspected allergy to the test drug and its excipients;
- Are receiving cytotoxic or biological therapy (such as TNF inhibitors, IL-1 inhibitors, IL-6 inhibitors (tocilizumab, adalimumab, etc.), T cell or B cell targeted therapy (rituximab, interferon, etc.), or Janus kinase (JAK) inhibitors, except for this study.
- Have received convalescent new coronary pneumonia plasma or intravenous human immunoglobulin; have received clearly effective COVID-19 virus neutralizing antibodies;
- In addition to the new crown infection, there are other serious infections, suspected serious bacteria, fungal viruses, active tuberculosis, NTM, etc.
- Known positive for HIV antibody, positive test for active hepatitis B virus (HBsAg positive, HBV-DNA positive or ≥1000 copies/mL), anti-HCV antibody or HCV-RNA positive;
- Have received a live vaccine within 1 week prior to screening, or are expected to be vaccinated during the study period.
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- Severe liver disease (total bilirubin (TBIL) ≥ 3 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≥5 times the upper limit of normal value);
- Those with severe renal insufficiency (glomerular filtration rate ≤ 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;
- Blood routine: neutrophil count < 1.0×109/L, lymphocyte count < 0.2×109/L, platelet < 30×109/L, hemoglobin < 60g/L;
- Patients with malabsorption syndrome, or any other condition that affects gastrointestinal absorption, requiring intravenous nutrition or unable to take oral medications;
- Invasive respiratory support or advanced life support, such as ECMO, is required.
- Patients who have suffered from malignant tumors in the past 5 years and are currently uncontrolled; (13) Patients who participated in other new drugs or medical devices within 1 month before screening and took the investigational drug and used the investigational device; (14) Pregnant or lactating female patients, female patients with fertility and male patients who refuse to use contraception during the trial and within 6 months after the end of the test; (15) having taken a strong CYP3A inhibitor (such as ketoconazole, clarithromycin, itraconazole) or a strong CYP3A4 inducer (rifampicin) within two weeks before the first dose; (16) Patients with congenital coagulation abnormalities, such as patients with a history of multiple thrombosis and bleeding diseases; (17) Alcohol dependence or drug abuse; The researchers believe that patients with rapid disease progression are unlikely to survive for at least 48 hours after screening; or other factors that are not suitable for participation in the trial。
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Clinical Study of Efficacy and Safety of Flunotinib Maleate Tablets Combined With Antiviral Therapy in Patients With Severe Novel Coronavirus (COVID-19) Infection
Flonoltinib Maleate (FM) is a triple-target inhibitor of JAK2, FLT3, and CDK6. It inhibited JAK2 with an IC50 of 0.8 nM, whereas its IC50 values against JAK1, JAK3, and TYK2 were 690 nM, 557 nM, and 65 nM, respectively, indicating high selectivity for JAK2 over other JAK family kinases. FM also inhibited FLT3 and CDK6 with IC50 values of 15 nM and 35 nM, respectively. In multiple pharmacodynamic models of inflammation, FM demonstrated favorable therapeutic efficacy and low toxicity.
- Conditions
- COVID-19
- Being tested
- SOC
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCDrug
In this study, the standard treatment plan (SOC) for COVID-19 in the Department of Respiratory and Critical Care Medicine was used as the best accessible treatment, and the treatment plan principle was based on the latest national guidance document ("Expert Recommendations for Clinical Treatment of Severe Novel Coronavirus Infection Caused by Omicron Variant"; "Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial Version 10)"; "Diagnosis and Treatment Plan for Severe Cases of Novel Coronavirus Infection (Trial Fourth Edition)"). In this study, the drug flunotinib maleate (FM) 100mg is a class of JAK inhibitors of anti-inflammatory therapy of SOC as standard clinical treatment regimen, and will be used in combination with SOC according to the judgment of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| FM+SOC | Experimental | Not described Receives: Drug: SOC |
| FM安慰剂 +SOC | Placebo comparator | Not described Receives: Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoints
The primary endpoint will assess the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) at day 28.
Measured: 28 day
Primary efficacy endpoints
Non-invasive ventilation/high-flow oxygen includes ventilatory support without the use of invasive artificial airways (endotracheal tubes or tracheostomy tubes).
Measured: 28 day
Primary efficacy endpoints
High-flow oxygen includes respiratory support through masks, nasal masks, etc.
Measured: 28 day
Secondary outcomes (8)
Secondary efficacy endpoints
Number of days hospitalized and admitted to the ICU (D1-D28);
Measured: 28 day
Secondary efficacy endpoints
If it is separated from oxygen therapy and maintained for 24 hours or without oxygen in the room, SpO2≥93 can be reached and maintained for 24 hours (D1-D28)
Measured: 28 day
Secondary efficacy endpoints
Duration of symptoms associated with COVID-19 infection (D1-D14)
Measured: 14 day
Secondary efficacy endpoints
The proportion and time of the WHO clinical status rating (from 0 (no viral infection) to 10 (death) decreased by two levels
Measured: 28 day
Secondary efficacy endpoints
To improve clinical time
Measured: 28 day
Secondary efficacy endpoints
Rehabilitation time (D1-D28) (Rehabilitation is defined as a patient meeting any of the minimum 3 scores on the NIAID-OS scale (see Appendix) on the first day or time of study initiation: hospitalization, no need for supplemental oxygen - no ongoing medical care is required; not hospitalized, limited mobility, and/or requiring home oxygen; Not hospitalized and with unlimited activities (also applies to normal discharge home)
Measured: 28 day
Secondary efficacy endpoints
Improvement of inflammatory factor levels.
Measured: 28 day
Secondary efficacy endpoints
Nucleic acid negative time (nucleic acid negative is defined as CT value≥35)
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start23 May 2023
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
Why it stopped: the pandemic of COVID-19 was over.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Chengdu Zenitar Biomedical Technology Co., LtdThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713279
- Sponsor's protocol ID
- ZLFM-003-2.0
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Clinical Study of Efficacy and Safety of Flunotinib Maleate Tablets Combined With Antiviral Therapy in Patients With Severe Novel Coronavirus (COVID-19) Infection
- ClinicalTrials.gov ID
- NCT05713279
- Acronym / sponsor ID
- ZLFM-003-2.0
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the pandemic of COVID-19 was over.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 6 Feb 2023 (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.
Flonoltinib Maleate (FM) is a triple-target inhibitor of JAK2, FLT3, and CDK6. It inhibited JAK2 with an IC50 of 0.8 nM, whereas its IC50 values against JAK1, JAK3, and TYK2 were 690 nM, 557 nM, and 65 nM, respectively, indicating high selectivity for JAK2 over other JAK family kinases. FM also inhibited FLT3 and CDK6 with IC50 values of 15 nM and 35 nM, respectively. In multiple pharmacodynamic models of inflammation, FM demonstrated favorable therapeutic efficacy and low toxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FM+SOC | Experimental | Drug: SOC |
| FM安慰剂 +SOC | Placebo comparator | Drug: SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age≥ 18 years old, gender is not limited;
- COVID-19 infection inclusion criteria: hospitalized with coronavirus (COVID-19) within 14 days, samples collected 72 hours before enrollment confirmed by polymerase chain reaction (PCR) test or antigen test (if due to lack of testing supplies, testing capacity and conditions are limited, but indicate a progressive disease with persistent infection with COVID-19), the investigator judged that the condition was aggravated, and any of the following criteria were met as severe COVID-19 patients:
- Respiratory distress, respiratory rate≥ 30 times/min; At rest, oxygen saturation ≤ 93% when inhaling air; Arterial partial pressure of oxygen (PaO2)/oxygen inhalation concentration (FiO2)≤ 300 mmHg; Clinical symptoms are progressively aggravated, lung imaging shows that the lesions within 24~48h have progressed significantly > 50%.
- Adults with any of the following are defined as critically ill with COVID-19: respiratory failure requiring mechanical ventilation; Appearance of shock; Other organ failure requires ICU monitoring; Severe and critical cases of novel coronavirus infection, collectively referred to as "severe cases". Severe cases can also be managed as severe cases if pneumonia caused by novel coronavirus infection does not meet the diagnostic criteria for severe cases: age > 65 years old, incomplete full vaccination, and more serious chronic diseases (including hypertension, diabetes, coronary heart disease, chronic lung disease, malignant tumors, and immunocompromise, etc.)
- Patients with risk of progression before enrollment: at least one inflammatory index greater than the upper limit of normal (IL-6, CRP, d-dimer, LDH, ferritin≥ULN) within 2 days;
Key exclusion criteria (12 listed)
- Known or suspected allergy to the test drug and its excipients;
- Are receiving cytotoxic or biological therapy (such as TNF inhibitors, IL-1 inhibitors, IL-6 inhibitors (tocilizumab, adalimumab, etc.), T cell or B cell targeted therapy (rituximab, interferon, etc.), or Janus kinase (JAK) inhibitors, except for this study.
- Have received convalescent new coronary pneumonia plasma or intravenous human immunoglobulin; have received clearly effective COVID-19 virus neutralizing antibodies;
- In addition to the new crown infection, there are other serious infections, suspected serious bacteria, fungal viruses, active tuberculosis, NTM, etc.
- Known positive for HIV antibody, positive test for active hepatitis B virus (HBsAg positive, HBV-DNA positive or ≥1000 copies/mL), anti-HCV antibody or HCV-RNA positive;
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 |
|---|---|---|
| SOCIn this study, the standard treatment plan (SOC) for COVID-19 in the Department of Respiratory and Critical Care Medicine was used as the best accessible treatment, and the treatment plan principle was based on the latest national guidance document ("Expert Recommendations for Clinical Treatment of Severe Novel Coronavirus Infection Caused by Omicron Variant"; "Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial Version 10)"; "Diagnosis and Treatment Plan for Severe Cases of Novel Coronavirus Infection (Trial Fourth Edition)"). In this study, the drug flunotinib maleate (FM) 100mg is a class of JAK inhibitors of anti-inflammatory therapy of SOC as standard clinical treatment regimen, and will be used in combination with SOC according to the judgment of the investigator. | Drug | FM+SOC, FM安慰剂 +SOC |
Primary outcome
Primary efficacy endpoints
Time frame: 28 day
The primary endpoint will assess the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) at day 28.
Primary efficacy endpoints
Time frame: 28 day
Non-invasive ventilation/high-flow oxygen includes ventilatory support without the use of invasive artificial airways (endotracheal tubes or tracheostomy tubes).
Primary efficacy endpoints
Time frame: 28 day
High-flow oxygen includes respiratory support through masks, nasal masks, etc.
8 secondary outcomes
Secondary efficacy endpoints
Time frame: 28 day
Secondary efficacy endpoints
Time frame: 28 day
Secondary efficacy endpoints
Time frame: 14 day
Secondary efficacy endpoints
Time frame: 28 day
Secondary efficacy endpoints
Time frame: 28 day
Secondary efficacy endpoints
Time frame: 28 day
Secondary efficacy endpoints
Time frame: 28 day
Secondary efficacy endpoints
Time frame: 28 day
Results and safety
The study was stopped early (reason given: the pandemic of COVID-19 was over.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOC in people with COVID-19, run by Chengdu Zenitar Biomedical Technology Co., Ltd 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Aug 2026. 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?
The study was stopped early (reason given: the pandemic of COVID-19 was over.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoints (time frame: 28 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.