A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
2 doses per day, 100mg Jaktinib
2 doses per day, placebo
Changsha Taihe Hospital
Changsha, Hunan, China
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 with disease progression or all-cause mortality
Time frame: 14 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
Efficacy of Jaktinib
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, and 14 days after randomization until the 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