This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 120 eligible patients with severe novel coronavirus pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
2 doses per day, each containing two 50mg Jaktinib or placebo tablets
West China Hospital Sichuan University
Chengdu, Sichuan, China
Efficacy of Jaktinib
The proportion of subjects with disease progression or all-cause mortality;
Time frame: 14 days after randomization
Efficacy of Jaktinib
The proportion of subjects with disease progression or all-cause mortality;
Time frame: 28 days after randomization
Efficacy of Jaktinib
The proportion of subjects whose (National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) score improved by ≥ 2 points from the baseline
Time frame: 28 days after randomization
Efficacy of Jaktinib
The change value of NIAID-OS score compared with the baseline
Time frame: 28 days after randomization
Efficacy of Jaktinib
Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points)
Time frame: up to 28 days after randomization
Time interval from randomization to discharge
Time frame: up to 28 days after randomization
Efficacy of Jaktinib
The proportion of subjects receiving mechanical ventilation due to disease progression at 3, 7, 14 days after randomization until end of treatment (EOT)
Time frame: 28 days after randomization
Efficacy of Jaktinib
the proportion of subjects whose chest High-Resolution CT (HRCT) showed significant absorption of pulmonary inflammation (definition of significant absorption: the lung inflammatory lesions were reduced by more than 50%) at 7, 14 days after treatment until EOT
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Time frame: 28 days after randomization
Safety of Jaktinib
Incidence rate of adverse events and serious adverse events
Time frame: up to 2 months after randomization