NCT05713279

Study of Flonoltinib Maleate Tablets in the Treatment of Severe Novel Coronavirus (COVID-19) Infection

Preliminary Clinical Study of Efficacy and Safety of Flunotinib Maleate Tablets Combined With Antiviral Therapy in Patients With Severe Novel Coronavirus (COVID-19) Infection

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Flonoltinib Maleate as a JAK/FLT3 dual target inhibitor, previous pharmacological experiments showed that the IC50 inhibition of JAK2 kinase was as low as 0.8 nM, while the IC50 inhibition of JAK1, JAK3 and TYK2 kinases was 26 nM, 39 nM and 2 nM, respectively, and the IC50 of FLT3 kinase was 15 nM. It has high inhibitory activity for JAK2 kinase and good selectivity for JAK family.Multiple pharmacodynamic models evaluating the anti-inflammatory effect of Flonoltinib Maleate showed that Flonoltinib Maleate showed better therapeutic effect than the clinical drug Ruxolitinib with lower toxicity.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	SOC	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.

Timeline

• Start date: 2023-01-19
• Primary completion: 2023-11-01
• Completion: 2023-11-30
• First posted: 2023-02-06
• Last updated: 2023-09-26

Locations

1 site across 1 country: China