Back to resultsEfficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
Primary Purpose
COVID-19 Pneumonia
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jaktinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring Pneumonia, COVID-19 Infection
Eligibility Criteria
Inclusion Criteria: 18 years of age, male or female; History of COVID-19 infection within 1 week; Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min. Clear consciousness, Capable and voluntary informed consent. Exclusion Criteria: Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption; Any person meeting criteria for critical pneumonia; Patients considered unsuitable for this trial by the investigator.
Sites / Locations
- The First Affiliated Hospital of College of Medicine Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Jaktinib
Placebo
Arm Description
Jaktinib 100mg BID
placebo
Outcomes
Primary Outcome Measures
Time to Recovery
Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. NIAID-OS: 1 Not hospitalized, no limitations on activities. 2 Not hospitalized, limitation on activities and/or requiring home oxygen. 3 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
Secondary Outcome Measures
Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT
Mortality
Proportion of patients with all-cause mortality at Day 28
Full Information
NCT ID
NCT05672888
First Posted
January 4, 2023
Last Updated
January 12, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05672888
Brief Title
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
Official Title
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
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 was a randomized, double-blind, placebo-controlled parallel study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
Pneumonia, COVID-19 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jaktinib
Arm Type
Experimental
Arm Description
Jaktinib 100mg BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
100mg of Jaktinib (given as two 50mg tablets) administered orally Twice daily(BID) with best available treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (given as two placebo tablets) administered orally BID with best available treatment.
Primary Outcome Measure Information:
Title
Time to Recovery
Description
Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. NIAID-OS: 1 Not hospitalized, no limitations on activities. 2 Not hospitalized, limitation on activities and/or requiring home oxygen. 3 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
Time Frame
Day 1 to Day 28
Secondary Outcome Measure Information:
Title
Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT
Time Frame
Day 3, 7, 14 or EOT
Title
Mortality
Description
Proportion of patients with all-cause mortality at Day 28
Time Frame
Day 1 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age, male or female;
History of COVID-19 infection within 1 week;
Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min.
Clear consciousness, Capable and voluntary informed consent.
Exclusion Criteria:
Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption;
Any person meeting criteria for critical pneumonia;
Patients considered unsuitable for this trial by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianya Zhou
Phone
0571-87235114
Email
zhoujianya@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianya Zhou
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of College of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianya Zhou
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
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