A Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

NCT05688839 | Unknown Phase 2

• 1 other identifier: ZGJAK-IIT-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 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

  28 days after randomization

• 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 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

• Efficacy of Jaktinib

  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, and 14 days after randomization until the 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: placebo

Interventions

Jaktinib hydrochloride tablets DRUG

2 doses per day, 100mg Jaktinib

Jaktinib 100mg BID

placebo DRUG

2 doses per day, placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years old, regardless of gender;
• There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1-2 weeks;
• 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 Participants 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 the 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)

Changsha Taihe Hospital

Changsha, Hunan, China

Location

Study Officials

• RongHu Li

  Changsha Taihe Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heng Li

CONTACT

+86 13787420314; 87088945@qq.com

XiaoLi Chai

CONTACT

+86 18674885619; chaijin9@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 9, 2023
• First Posted: January 18, 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)