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

NCT05713279 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Chengdu Zenitar Biomedical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2023-12-01
Completion
2023-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05713279 on ClinicalTrials.gov