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

COVID-19 Clinical Trial

— COVID-19  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05702788
• Other study ID #: ZGJAK032
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2022
• Est. completion date: April 23, 2024

Study information

• Verified date: April 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 23, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Drug:
• Jaktinib hydrochloride tablets
75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.
• Jaktinib hydrochloride tablets
100mg of Jaktinib administered orally Twice daily(BID) with best available treatment.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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