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

Zelgen Biopharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19; Pneumonia

Treatments: Drug: Jaktinib hydrochloride tablets; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05702788

ZGJAK032

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Jaktinib 75mg BID

Experimental group

Description:

Jaktinib 75mg BID

Treatment:

Drug: Jaktinib hydrochloride tablets

Drug: Jaktinib hydrochloride tablets

Jaktinib 100mg BID

Experimental group

Description:

Jaktinib 100mg BID

Treatment:

Drug: Jaktinib hydrochloride tablets

Drug: Jaktinib hydrochloride tablets

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo