An Efficacy and Safety Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

A Study to Assess the Efficacy and Safety of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 120 eligible patients with severe novel coronavirus pneumonia.

Study Overview

• Status: Not yet recruiting
• Conditions: Novel COVID-19-Infected Pneumonia
• Intervention / Treatment: Drug: Jaktinib hydrochloride tablets

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhu Luo; Phone Number: +86 18980606557; Email: luozhu720@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610042
      • West China Hospital Sichuan University
      • Contact: Zhu Luo; Phone Number: +86 18980606557

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 to 80 years old (including threshold), regardless of gender;
• There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1 week;
• HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator)
• Participants who voluntarily sign informed consent.

Exclusion Criteria:

• Participants who cannot take orally, or are suspected to be allergic to Jaktinib hydrochloride, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
• Critical pneumonia patients with other organ failure requiring ICU monitoring and treatment;

• Participants who have received the following treatments within the specified time window before randomization:

  1. participants have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid;
  2. Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random;
• Immune deficiency;
• Participants who have received novel coronavirus vaccine within 1 week before randomization;
• Prior to randomization, there were the following active and uncontrolled infections: tuberculosis, HIV, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than SARS CoV-2 that required systemic anti-infection treatment;
• Renal diseases requiring dialysis treatment;
• Pregnant and lactating women;
• Any other participants that were considered unsuitable by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jaktinib 100mg BID; Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID	Drug: Jaktinib hydrochloride tablets; 2 doses per day, each containing two 50mg Jaktinib or placebo tablets
Placebo Comparator: Placebo; 2 x Placebo tablets, BID	Drug: Jaktinib hydrochloride tablets; 2 doses per day, each containing two 50mg Jaktinib or placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Jaktinib	The proportion of subjects with disease progression or all-cause mortality;	14 days after randomization
Efficacy of Jaktinib	The proportion of subjects with disease progression or all-cause mortality;	28 days after randomization
Efficacy of Jaktinib	The proportion of subjects whose (National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) score improved by ≥ 2 points from the baseline	28 days after randomization
Efficacy of Jaktinib	The change value of NIAID-OS score compared with the baseline	28 days after randomization
Efficacy of Jaktinib	Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points)	up to 28 days after randomization
Efficacy of Jaktinib	The proportion of subjects receiving mechanical ventilation due to disease progression at 3, 7, 14 days after randomization until end of treatment (EOT)	28 days after randomization
Efficacy of Jaktinib	the proportion of subjects whose chest High-Resolution CT (HRCT) showed significant absorption of pulmonary inflammation (definition of significant absorption: the lung inflammatory lesions were reduced by more than 50%) at 7, 14 days after treatment until EOT	28 days after randomization
Time interval from randomization to discharge		up to 28 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Jaktinib	Incidence rate of adverse events and serious adverse events	up to 2 months after randomization

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Weimin Li, Prof., West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: ZGJAK-IIT-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No