Novel COVID-19-Infected Pneumonia
Conditions
Brief summary
A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia.
Interventions
2 doses per day, 100mg Jaktinib
DRUGplacebo
2 doses per day, placebo
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Jaktinib | 28 days after randomization | The proportion of subjects with disease progression or all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Jaktinib | Up to 2 months after randomization | Incidence rate of adverse events and serious adverse events |
Countries
China
Contacts
Primary ContactHeng Li
Backup ContactXiaoLi Chai
Outcome results
None listed