An Efficacy and Safety Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

NCT05686629 | Unknown Phase 2

• 1 other identifier: ZGJAK-IIT-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 120 eligible patients with severe novel coronavirus pneumonia.

Conditions

Novel COVID-19-Infected Pneumonia

Outcome Measures

Primary Outcomes (8)

• Efficacy of Jaktinib

  The proportion of subjects with disease progression or all-cause mortality;

  14 days after randomization

• Efficacy of Jaktinib

  The proportion of subjects with disease progression or all-cause mortality;

  28 days after randomization

• Efficacy of Jaktinib

  The proportion of subjects whose (National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) score improved by ≥ 2 points from the baseline

  28 days after randomization

• Efficacy of Jaktinib

  The change value of NIAID-OS score compared with the baseline

  28 days after randomization

• Efficacy of Jaktinib

  Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points)

  up to 28 days after randomization

• Time interval from randomization to discharge

  up to 28 days after randomization

• Efficacy of Jaktinib

  The proportion of subjects receiving mechanical ventilation due to disease progression at 3, 7, 14 days after randomization until end of treatment (EOT)

  28 days after randomization

• Efficacy of Jaktinib

  the proportion of subjects whose chest High-Resolution CT (HRCT) showed significant absorption of pulmonary inflammation (definition of significant absorption: the lung inflammatory lesions were reduced by more than 50%) at 7, 14 days after treatment until EOT

  28 days after randomization

Secondary Outcomes (1)

• Safety of Jaktinib

  up to 2 months after randomization

Study Arms (2)

Jaktinib 100mg BID

EXPERIMENTAL

Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID

Drug: Jaktinib hydrochloride tablets

Placebo

PLACEBO COMPARATOR

2 x Placebo tablets, BID

Drug: Jaktinib hydrochloride tablets

Interventions

Jaktinib hydrochloride tablets DRUG

2 doses per day, each containing two 50mg Jaktinib or placebo tablets

Jaktinib 100mg BID; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years old (including threshold), regardless of gender;
• There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1 week;
• HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator)
• Participants who voluntarily sign informed consent.

You may not qualify if:

• Participants who cannot take orally, or are suspected to be allergic to Jaktinib hydrochloride, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
• Critical pneumonia patients with other organ failure requiring ICU monitoring and treatment;
• 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;
• Participants who have received novel coronavirus vaccine within 1 week before randomization;
• Prior to randomization, there were the following active and uncontrolled infections: tuberculosis, HIV, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than SARS CoV-2 that required systemic anti-infection treatment;
• Renal diseases requiring dialysis treatment;
• Pregnant and lactating women;
• Any other participants that were considered unsuitable by the investigator.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

West China Hospital Sichuan University

Chengdu, Sichuan, 610042, China

Location

Study Officials

• Weimin Li, Prof.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhu Luo

CONTACT

+86 18980606557; luozhu720@163.com

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 8, 2023
• First Posted: January 17, 2023
• Study Start: April 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)