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NCT05686629
An Efficacy and Safety Study of Jacktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia
Conditions: Novel COVID-19-Infected Pneumonia
Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE2
Enrollment: 120
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Location: China
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)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: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;Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random;Immune deficiency;Those 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 subjects that were considered unsuitable by the investigator.
Source: ClinicalTrials.gov (NCT05686629). StuddyBuddy aggregates publicly available trial information.