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

Phase 2

Withdrawn

• Conditions: COVID-19; Pneumonia
• Interventions: Drug: Jaktinib hydrochloride tablets; Other: Placebo

• Registration Number: NCT05702788
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-27
• Status Verified: 2024-04
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-23
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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:

  1. 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;
  2. Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random;

• Immune deficiency;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaktinib 75mg BID	Jaktinib hydrochloride tablets	Jaktinib 75mg BID
Jaktinib 100mg BID	Jaktinib hydrochloride tablets	Jaktinib 100mg BID
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
The proportion of Participants who develop death or respiratory failure.	28 days after randomization	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.

Secondary Outcome Measures

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