An Efficacy and Safety Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

Study Overview
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Brief Summary
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This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 120 eligible patients with severe novel coronavirus pneumonia.

Official Title
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A Study to Assess the Efficacy and Safety of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

Conditions
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Novel COVID-19-Infected Pneumonia

Intervention / Treatment
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* Drug: Jaktinib hydrochloride tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years old (including threshold), regardless of gender; There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1 week; HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator) Participants who voluntarily sign informed consent. Exclusion Criteria: Participants who cannot take orally, or are suspected to be allergic to Jaktinib hydrochloride, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption; Critical pneumonia patients with other organ failure requiring ICU monitoring and treatment; Participants who have received the following treatments within the specified time window before randomization: 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; Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random; Immune deficiency; Participants who have received novel coronavirus vaccine within 1 week before randomization; Prior to randomization, there were the following active and uncontrolled infections: tuberculosis, HIV, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than SARS CoV-2 that required systemic anti-infection treatment; Renal diseases requiring dialysis treatment; Pregnant and lactating women; Any other participants that were considered unsuitable by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib 100mg BID<br>Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID | Drug: Jaktinib hydrochloride tablets<br>* 2 doses per day, each containing two 50mg Jaktinib or placebo tablets<br>|
| Placebo Comparator: Placebo<br>2 x Placebo tablets, BID | Drug: Jaktinib hydrochloride tablets<br>* 2 doses per day, each containing two 50mg Jaktinib or placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Jaktinib | The proportion of subjects with disease progression or all-cause mortality; | 14 days after randomization | 
| Efficacy of Jaktinib | The proportion of subjects with disease progression or all-cause mortality; | 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 | 28 days after randomization | 
| Efficacy of Jaktinib | The change value of NIAID-OS score compared with the baseline | 28 days after randomization | 
| Efficacy of Jaktinib | Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points) | up to 28 days after randomization | 
| Time interval from randomization to discharge |  | 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) | 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 | 28 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Jaktinib | Incidence rate of adverse events and serious adverse events | up to 2 months after randomization |