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NCT05702788 | Withdrawn | COVID-19

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

Condition or disease

COVID-19

Pneumonia

Intervention/treatment

Jaktinib hydrochloride tablets

Jaktinib hydrochloride tablets

Placebo

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 0 participants
Masking : Double
Primary Purpose : Treatment
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
Actual Study Start Date : September 2022
Estimated Primary Completion Date : April 23, 2024
Estimated Study Completion Date : April 23, 2024
Arm Intervention/treatment

Experimental: Jaktinib 75mg BID

Jaktinib 75mg BID

Drug: Jaktinib hydrochloride tablets

Experimental: Jaktinib 100mg BID

Jaktinib 100mg BID

Drug: Jaktinib hydrochloride tablets

Placebo Comparator: Placebo

Placebo

Other: Placebo
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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;
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)

Location Details

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

How to Participate

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