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

Phase 2

Not yet recruiting

• Conditions: Novel COVID-19-Infected Pneumonia
• Interventions: Drug: Jaktinib hydrochloride tablets

• Registration Number: NCT05686629
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24
• Study Start: 2024-04
• Primary Completion: 2025-02
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaktinib 100mg BID	Jaktinib hydrochloride tablets	Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID
Placebo	Jaktinib hydrochloride tablets	2 x Placebo tablets, BID

Primary Outcome Measures

Name	Time	Method
Efficacy of Jaktinib	28 days after randomization	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
Time interval from randomization to discharge	up to 28 days after randomization

Secondary Outcome Measures

Name	Time	Method
Safety of Jaktinib	up to 2 months after randomization	Incidence rate of adverse events and serious adverse events

Trial Locations

Locations (1)

West China Hospital Sichuan University; 🇨🇳 Chengdu, Sichuan, China