A randomized, double-blind, placebo parallel control study and is expected to enroll20-60 eligible patients with severe novel coronavirus pneumonia.
Not Provided
Drug: Jaktinib hydrochloride tablets
2 doses per day, 100mg Jaktinib
Drug: placebo
2 doses per day, placebo
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.
Changsha Taihe Hospital
Changsha, Hunan, China
Investigator: Heng Li
Contact: +86 13787420314
Heng Li
+86 13787420314
87088945@qq.com
XiaoLi Chai
+86 18674885619
chaijin9@163.com
RongHu Li, Principal Investigator
Changsha Taihe Hospital