Efficacy and Safety of Jaktinib in Patients With Severe Novel Noronavirus Pneumonia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Jaktinib 75mg BID Jaktinib 75mg BID |
Drug: Jaktinib hydrochloride tablets
75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.
|
| Experimental: Jaktinib 100mg BID Jaktinib 100mg BID |
Drug: Jaktinib hydrochloride tablets
100mg of Jaktinib administered orally Twice daily(BID) with best available treatment.
|
| Placebo Comparator: Placebo Placebo |
Other: Placebo
Placebo (given as two placebo tablets) administered orally BID with best available treatment.
|
Outcome Measures
Primary Outcome Measures
- The proportion of subjects who develop death or respiratory failure. [28 days after randomization]
Respiratory failure is defined as subjects who on invasive mechanical ventilation or ECMO or on non-invasive ventilation or high-flow oxygen devices.
Secondary Outcome Measures
- The proportion of subjects who develop death or respiratory failure. [14 days after randomization]
Respiratory failure is defined as subjects who on invasive mechanical ventilation or ECMO or on non-invasive ventilation or high-flow oxygen devices.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age, male or female;
-
The subject was diagnosed with novel coronavirus pneumonia;
-
It meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9).
-
Those who voluntarily sign informed consent.
-
The National Institute of Allergy and Infectious Diseases Sequential Scale (NIAID-0S) score is 5 or 6;
Exclusion Criteria:
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Those 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;
-
Those who have received the following treatments within the specified time window before randomization:
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They 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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Third People Hospital of Shenzhen | Shenzhen | Guangdong | China |
Sponsors and Collaborators
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
- Principal Investigator: Hongzhou Lu, The Third People Hospital of Shenzhen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZGJAK032