Study of Flonoltinib Maleate Tablets in the Treatment of Severe Novel Coronavirus (COVID-19) Infe… (NCT05713279) | Clinical Trial Compass
TerminatedNot Applicable
Study of Flonoltinib Maleate Tablets in the Treatment of Severe Novel Coronavirus (COVID-19) Infection
Stopped: the pandemic of COVID-19 was over.
China13 participantsStarted 2023-05-23
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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;