Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)

A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study to Evaluate the Efficacy and Safety of Jaktinib Hydrochloride Tablets in Participants Receiving the Best Available Treatment for Severe Novel Coronavirus Pneumonia

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05702788

Acronym

COVID-19

Enrollment

Registered

2023-01-27

Start date

2022-09-30

Completion date

2024-04-23

Last updated

2024-04-26

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

Conditions

COVID-19, Pneumonia

Brief summary

This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.

Interventions

DRUGJaktinib hydrochloride tablets

75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.

OTHERPlacebo

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

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

Inclusion criteria

* 18 years of age, male or female; * The Participants was diagnosed with novel coronavirus pneumonia; * It meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9). * Participants who voluntarily sign informed consent. * The National Institute of Allergy and Infectious Diseases Sequential Scale (NIAID-0S) score is 5 or 6;

Exclusion criteria

* Participants who cannot take orally, or are suspected to be allergic to Jaktinib, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption; * Participants who have received the following treatments within the specified time window before randomization: 1. 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; 2. Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random; * Immune deficiency;

Design outcomes

Primary

Measure	Time frame	Description
The proportion of Participants who develop death or respiratory failure.	28 days after randomization	Respiratory failure is defined as Participants who on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation(ECMO) or on non-invasive ventilation or high-flow oxygen devices.

Secondary

Measure	Time frame	Description
The proportion of Participants who develop death or respiratory failure.	14 days after randomization	Respiratory failure is defined as Participants who on invasive mechanical ventilation or ECMO or on non-invasive ventilation or high-flow oxygen devices.

Outcome results

None listed

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