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

Primary Purpose

Novel COVID-19-Infected Pneumonia

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jaktinib hydrochloride tablets
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Novel COVID-19-Infected Pneumonia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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; 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.

Sites / Locations

  • West China Hospital Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jaktinib 100mg BID

Placebo

Arm Description

Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID

2 x Placebo tablets, BID

Outcomes

Primary Outcome Measures

Efficacy of Jaktinib
The proportion of subjects with disease progression or all-cause mortality;
Efficacy of Jaktinib
The proportion of subjects with disease progression or all-cause mortality;
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
Efficacy of Jaktinib
The change value of NIAID-OS score compared with the baseline
Efficacy of Jaktinib
Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points)
Time interval from randomization to discharge
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)
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

Secondary Outcome Measures

Safety of Jaktinib
Incidence rate of adverse events and serious adverse events

Full Information

First Posted
January 8, 2023
Last Updated
October 22, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05686629
Brief Title
An Efficacy and Safety Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia
Official Title
A Study to Assess the Efficacy and Safety of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2024 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Novel COVID-19-Infected Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jaktinib 100mg BID
Arm Type
Experimental
Arm Description
Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 x Placebo tablets, BID
Intervention Type
Drug
Intervention Name(s)
Jaktinib hydrochloride tablets
Intervention Description
2 doses per day, each containing two 50mg Jaktinib or placebo tablets
Primary Outcome Measure Information:
Title
Efficacy of Jaktinib
Description
The proportion of subjects with disease progression or all-cause mortality;
Time Frame
14 days after randomization
Title
Efficacy of Jaktinib
Description
The proportion of subjects with disease progression or all-cause mortality;
Time Frame
28 days after randomization
Title
Efficacy of Jaktinib
Description
The proportion of subjects whose (National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) score improved by ≥ 2 points from the baseline
Time Frame
28 days after randomization
Title
Efficacy of Jaktinib
Description
The change value of NIAID-OS score compared with the baseline
Time Frame
28 days after randomization
Title
Efficacy of Jaktinib
Description
Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points)
Time Frame
up to 28 days after randomization
Title
Time interval from randomization to discharge
Time Frame
up to 28 days after randomization
Title
Efficacy of Jaktinib
Description
The proportion of subjects receiving mechanical ventilation due to disease progression at 3, 7, 14 days after randomization until end of treatment (EOT)
Time Frame
28 days after randomization
Title
Efficacy of Jaktinib
Description
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
Time Frame
28 days after randomization
Secondary Outcome Measure Information:
Title
Safety of Jaktinib
Description
Incidence rate of adverse events and serious adverse events
Time Frame
up to 2 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Luo
Phone
+86 18980606557
Email
luozhu720@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weimin Li, Prof.
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Luo
Phone
+86 18980606557

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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