A Second Study to Assess the Efficacy and Safety of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

ZGJAK-IIT-005

A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia.

2024-04-01

2025-02-01

2025-03-01

Not yet recruiting

Early phase I

60

Inclusion Criteria: * 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. 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 Participants 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 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-10-24