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

NCT ID: NCT05686629

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Jaktinib 100mg BID

Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID

Group Type: EXPERIMENTAL

Jaktinib hydrochloride tablets

Intervention Type: DRUG

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

Placebo

2 x Placebo tablets, BID

Group Type: PLACEBO_COMPARATOR

Jaktinib hydrochloride tablets

Intervention Type: DRUG

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

Interventions

Jaktinib hydrochloride tablets

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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:

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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weimin Li, Prof.

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Zhu Luo

Role: CONTACT

luozhu720@163.com

+86 18980606557

Facility Contacts

Zhu Luo

Role: primary

+86 18980606557

Other Identifiers

ZGJAK-IIT-004

Identifier Type: -

Identifier Source: org_study_id