Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
severe NCP group:Routine standard therapy + Jacketinib hydrochloride tablets (oral, the first 3 subjects were given a dose of 50mg Bid for 7 consecutive days
the current 3 subjects had no grade =3 drug-related adverse effects within D8 days). In the event, subsequent subjects were given 100 mg Bid for 7 consecutive
Acute exacerbation NCP group:Routine standard therapy + Jacketinib hydrochloride tablets (oral, the first 3 subjects were given a dose of 50mg Bid for 7 consecutive days
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Inpatients aged 50 and over, regardless of gender, voluntarily signed informed consent; (2) Persons diagnosed with 2019-nCoV infection: respiratory specimens or blood specimens are tested positive for 2019-nCoV nucleic acid by real-time fluorescent RT-PCR; or respiratory specimens or blood specimens are sequenced for viral genes, which are highly homologous with known 2019-nCoV; (3) Severe NCP group: meets ("New Coronavirus Infected Pneumonia Diagnosis and Treatment Plan (Trial Fifth Edition)") diagnostic criteria for heavy NCP. (4) NCP group in acute exacerbation period: NCP patients with acute exacerbation period in general to severe and critically severe (for definition of severe and critically severe, see "Pneumonitis Diagnosis and Treatment Program for New Coronavirus Infection (Trial Fifth Edition)"); Remarks: "Judgment Criteria for NCP Patients with Acute Exacerbation in General to Severe and Critical Severity" 1) Aged 50 years or older; 2) Dyspnea (those who inhale oxygen in a mask); 3) Combined with basic diseases, such as COPD, diabetes, hypertension, coronary heart disease; 4) White blood cell count is less than 4 × 109 / L or has a tendency to decrease continuously; 5) Lymphocyte count =10 mg / L or a trend of continuous increase; 9) Procalcitonin >=0.5 ng / mL or a tendency of continuous increase; 10) Lactate dehydrogenase >=250 U/L or a trend of continuous increase; 11) Aspartate aminotransferase and alanine aminotransferase have a tendency to increase continuously; 12) Creatinine >=133 umol/L or a tendency of continuous increase; 13) D-dimer >=0.5 mg/L or a trend of continuous increase; 14) There is a continuous decrease in serum potassium; 15) IL-6 has a tendency to increase continuously; 16) Any of IL-2, IL-4, IL-10, TNF, IFN-r, and IL-17A has a tendency to increase continuously; 17) Imaging findings consistent with NCP progression. Remarks: (1) If 9 or more of the above 17 items are met, they are judged to be "normal-to-severe, severely severe NCP patients with acute exacerbation period"; (2) continuous increase or decrease trend: at least 3 consecutive measurements, specific trends Determined by the research doctor; (3) In view of the special circumstances of the NCP, during the trial implementation, the selection criteria of the protocol can be appropriately updated and adjusted according to the clinical progress.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the severe NCP group were the same as those for the acutely exacerbated NCP group: 1. Have a history of drug dependence or substance abuse; 2. female patients who are pregnant or lactating; 3. People with allergies or known allergies to research drugs and excipients; 4. In patients with impaired liver function, alanine aminotransferase (ALT) / aspartate aminotransferase (AST) increases more than five times the upper limit of normal; 5. Patients with renal impairment (dialysis treatment patients or eGFR 4 times / day; 12. People who have difficulty swallowing oral drugs; 13. Situations in which other researchers find it inappropriate to participate in research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe NCP group: Time to clinical improvement (TTCI) [time window: 28 days];Acute exacerbation NCP group: Time to clinical recovery [time window: 28 days] and the ratio of common to severe and critically severe.; | — |
Countries
China
Contacts
Public ContactLu Hongzhou
Shanghai Public Health Clinical Center
Outcome results
None listed