Overview

A Study of Jacktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
All
Summary
A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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)

- Those who voluntarily sign informed consent.

Exclusion Criteria:

- Those who cannot take orally, or are suspected to be allergic to jackitinib
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;

- Those who have received the following treatments within the specified time window
before randomization:

1. They 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;

- Those 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 subjects that were considered unsuitable by the investigator.