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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
COVID-19, Pneumonia

Intervention / Treatment
-----------------
* Drug: Jaktinib hydrochloride tablets
* Drug: Jaktinib hydrochloride tablets
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib 75mg BID<br>Jaktinib 75mg BID | Drug: Jaktinib hydrochloride tablets<br>* 75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.<br>|
| Experimental: Jaktinib 100mg BID<br>Jaktinib 100mg BID | Drug: Jaktinib hydrochloride tablets<br>* 100mg of Jaktinib administered orally Twice daily(BID) with best available treatment.<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo (given as two placebo tablets) administered orally BID with best available treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of Participants who develop death or respiratory failure. | 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. | 28 days after randomization | 

Secondary Outcome Measures

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