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Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05672888
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a randomized, double-blind, placebo-controlled parallel study.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Jaktinib

Jaktinib 100mg BID

Drug: Jaktinib
100mg of Jaktinib (given as two 50mg tablets) administered orally Twice daily(BID) with best available treatment.
Placebo Comparator: Placebo

placebo

Drug: Placebo
Placebo (given as two placebo tablets) administered orally BID with best available treatment.

Outcome Measures

Primary Outcome Measures

  1. Time to Recovery [Day 1 to Day 28]

    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

  1. Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT [Day 3, 7, 14 or EOT]

  2. Mortality [Day 1 to Day 28]

    Proportion of patients with all-cause mortality at Day 28

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of College of Medicine Zhejiang University Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • First Affiliated Hospital of Zhejiang University

Investigators

  • Principal Investigator: Jianya Zhou, First Affiliated Hospital of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier:
NCT05672888
Other Study ID Numbers:
  • ZGJAK-IIT-002
First Posted:
Jan 5, 2023
Last Update Posted:
Jan 17, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by First Affiliated Hospital of Zhejiang University
Pneumonia
COVID-19 Infection
Additional relevant MeSH terms:
COVID-19
Pneumonia

Study Results

No Results Posted as of Jan 17, 2023