Novel COVID-19-Infected Pneumonia
Conditions
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.
Interventions
2 doses per day, each containing two 50mg Jaktinib or placebo tablets
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 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Jaktinib | 14 days after randomization | The proportion of subjects with disease progression or all-cause mortality; |
| Time interval from randomization to discharge | up to 28 days after randomization | — |
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 ContactZhu Luo
Outcome results
None listed