Clinical trial NCT05686629: An Efficacy and Safety Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia
Official title: A Study to Assess the Efficacy and Safety of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Novel COVID-19-Infected Pneumonia
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of Jaktinib
timeFrame: 14 days after randomization
measure: Efficacy of Jaktinib
timeFrame: 28 days after randomization
measure: Efficacy of Jaktinib
timeFrame: 28 days after randomization
measure: Efficacy of Jaktinib
timeFrame: 28 days after randomization
measure: Efficacy of Jaktinib
timeFrame: up to 28 days after randomization
measure: Time interval from randomization to discharge
timeFrame: up to 28 days after randomization
measure: Efficacy of Jaktinib
timeFrame: 28 days after randomization
measure: Efficacy of Jaktinib
timeFrame: 28 days after randomization
Secondary outcomes:
measure: Safety of Jaktinib
timeFrame: up to 2 months after randomization
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Weimin Li, Prof.
role: PRINCIPAL_INVESTIGATOR
References: