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Status unknownNCT05672888Updated Jan 17, 2023

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

A Phase 2 interventional study of Jaktinib and Placebo in COVID-19 Pneumonia, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-17.

Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • COVID-19 Pneumonia

Keywords

  • Pneumonia
  • COVID-19 Infection
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Jaktinib

    Jaktinib 100mg BID

    Drug: Jaktinib

  • Placebo comparator
    Placebo

    placebo

    Drug: Placebo

Interventions

  • DrugJaktinib

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 to Day 28

Secondary outcomes

  1. 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

  2. Mortality

    Proportion of patients with all-cause mortality at Day 28

    Time frame: Day 1 to Day 28

07

Study locations

1 site
  • The First Affiliated Hospital of College of Medicine Zhejiang University
    Hangzhou, Zhejiang 310000, China
    • Jianya Zhou · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05672888
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Sponsor
First posted
Jan 5, 2023
Start date
Mar 2023 (estimated)
Primary completion
Jan 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Jan 17, 2023

Study contacts

Jianya Zhou
Contact
zhoujianya@hotmail.com
0571-87235114
Jianya Zhou
principal investigator · First Affiliated Hospital of Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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