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

NCT05702788 | Withdrawn Phase 2

• 1 other identifier: ZGJAK032
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The proportion of Participants who develop death or respiratory failure.

  14 days after randomization

Study Arms (3)

Jaktinib 75mg BID

EXPERIMENTAL

Jaktinib 75mg BID

Drug: Jaktinib hydrochloride tablets

Jaktinib 100mg BID

EXPERIMENTAL

Jaktinib 100mg BID

Drug: Jaktinib hydrochloride tablets

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Jaktinib hydrochloride tablets DRUG

75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.

Jaktinib 75mg BID

Placebo OTHER

Placebo (given as two placebo tablets) administered orally BID with best available treatment.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

MeSH Terms

Conditions

COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hongzhou Lu

  The Third People Hospital of Shenzhen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: September 1, 2022
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share