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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05672888
Enrollment
60
Registered
2023-01-05
Start date
2023-03-31
Completion date
2024-05-31
Last updated
2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia

Keywords

Pneumonia, COVID-19 Infection

Brief summary

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

Interventions

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.

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Time to RecoveryDay 1 to Day 28Recovery 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

MeasureTime frameDescription
Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOTDay 3, 7, 14 or EOT
MortalityDay 1 to Day 28Proportion of patients with all-cause mortality at Day 28

Countries

China

Contacts

Primary ContactJianya Zhou
zhoujianya@hotmail.com0571-87235114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026