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

A randomized, double-blind, placebo parallel control study and is expected to enroll20-60 eligible patients with severe novel coronavirus pneumonia.

Detailed Description

Not Provided

Not yet recruiting
Novel COVID-19-Infected Pneumonia

Drug: Jaktinib hydrochloride tablets

2 doses per day, 100mg Jaktinib

Drug: placebo

2 doses per day, placebo

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Changsha Taihe Hospital
Changsha, Hunan, China

Investigator: Heng Li
Contact: +86 13787420314

Contacts

Heng Li
+86 13787420314
87088945@qq.com

XiaoLi Chai
+86 18674885619
chaijin9@163.com

RongHu Li, Principal Investigator
Changsha Taihe Hospital

Suzhou Zelgen Biopharmaceuticals Co.,Ltd
NCT Number
MeSH Terms
Pneumonia