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

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

This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; Pneumonia
• Intervention / Treatment: Drug: Jaktinib hydrochloride tablets; Drug: Jaktinib hydrochloride tablets; Other: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • The Third People Hospital of Shenzhen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Hongzhou Lu, The Third People Hospital of Shenzhen

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2022
• Primary Completion (Actual): April 23, 2024
• Study Completion (Actual): April 23, 2024

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: ZGJAK032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No