Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
intervention group:Lopinavir-ritonavir tablets (each containing 200 mg of lopinavir and 50 mg of ritonavir), twice a day, 2 tablets at a time
Sponsors
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult aged >=18years old; 2. Patients infected with new coronavirus confirmed by PCR 3. In the state of no oxygen at rest, the patient's SPO2<=94% or the oxygenation index is less than 300mmHg.
Exclusion criteria
Exclusion criteria: 1. Any situation that makes the programme cannot proceed safely; 2. Known allergy or hypersensitivity reaction to lopinavir / ritonavir; 3. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal; 4. Use of medications that are contraindicated with lopinavir / ritonavir and that cannot be replaced or stopped during the study period, such as CYP3A inhibitors; 5. Pregnancy: positive pregnancy test for women of childbearing age; 6. Known HIV infection, because of concerns about the development of resistance to lopinavir/rionavir if used without combination with other anti-HIV drugs; 7. Patient likely to be transferred to a non-participating hospital within 72 hours; 8. Researchers consider unsuitable.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoint was time to clinical improvement (TTCI);Proportion of patients in each category of the 7-point scale on days 7, 14, and 28 after randomization;;mortality on day 28;Duration of mechanical ventilation(days);Duration of oxygen therapy (days);Duration of hospitalization (days);Dynamic changes of virus in respiratory / blood / anal swab specimens;Frequency of Serious Adverse Drug Events; | — |
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement time of 28 days after randomization;The 7-point scale;7 points: death;6 points: admission to ECMO and / or mechanical ventilation;5 points: Hospitalized for non-invasive ventilation and / or high-flow oxygen therapy;4 points: hospitalization for oxygen therapy;3 points: Hospitalization does not require oxygen therapy;2 points: discharged but not restored to normal functional status;1 point: discharged to normal function; | — |
Countries
China
Contacts
Public ContactZhang Dingyu
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)
Outcome results
None listed