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NCT05702788 | WITHDRAWN | COVID-19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

PHASE2

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 : 2022-09
Estimated Primary Completion Date : 2024-04-23
Estimated Study Completion Date : 2024-04-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • 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;
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)

Location Details

NCT05702788

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