This study adopts a randomized, double-blind, placebo parallel control design, and isexpected to include 120 eligible patients with severe novel coronavirus pneumonia.
Not Provided
Drug: Jaktinib hydrochloride tablets
2 doses per day, each containing two 50mg Jaktinib or placebo tablets
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.
West China Hospital Sichuan University
Chengdu, Sichuan, China
Investigator: Zhu Luo
Contact: +86 18980606557
Zhu Luo
+86 18980606557
luozhu720@163.com
Weimin Li, Prof., Principal Investigator
West China Hospital