novel coronavirus pneumonia (COVID-19)
Conditions
Interventions
experimental group:conventional standardized treatment and Lopinavir-Ritonavir
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult aged >= 18 years old; 2. Patients with unexplained viral pneumonia that have been clinically diagnosed or patients with novel coronavirus serum antibody (IgM or IgG) positive or patients with novel coronavirus infection confirmed by PCR when no rapid diagnostic kit has been developed; 3. The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
Exclusion criteria
Exclusion criteria: 1) Any situation that makes the programme cannot proceed safely; 2) patients who have used Kaletra or remdesivir; 3) no clinical or chest imaging manifestations; 4) In the state of no oxygen at rest, the patient's SPO2 = 24/min; 5) Patients who need to be admitted to ICU judged by clinicians; 6) Known allergy or hypersensitivity reaction to lopinavir / ritonavir; 7) Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 3 times the upper limit of normal; 8) Drugs that are forbidden to be treated with lopinavir / ritonavir and cannot be replaced or stopped during the study period, such as afzosin, amiodarone, fusidic acid, astemizole, terfenadine, piperazine, dihydroergomethane, ergometrine Alkali, ergotamine, methylergometrine, cisapride, lovastatin, simvastatin, sildenafil, vartanafi, midazolam, triazolam, St. John's wort (Hypericum perforatum extract), etc.; 9) Pregnancy: positive pregnancy test for women of childbearing age; 10) lactating women did not stop lactation; 11) Known HIV infection, because of concerns about the development of resistance to lopinavir/rionavir if used without combination with other anti-HIV drugs; 12) Patient likely to be transferred to a non-participating hospital within 72 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse outcome within 14 days after admission: Patients with conscious dyspnea, SpO2 = 94% or respiratory frequency = 24 times / min in the state of resting without oxygen inhalation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from admission to clinical remission: Improvement of clinical symptom was defined as: Patients with normal body temperature > 72 hours (without taking antipyretic drugs or hormones) and no conscious dyspnea or reduction of dyspnea;The proportion of patients with normal body temperature 14 days after admission;The proportion of patients without cough 14 days after admission;The proportion of patients without dyspnea 14 days after admission;The proportion of patients without aerobic therapy 14 days after admission;The negative rate of novel coronavirus RNA in upper and lower respiratory tract samples of patients on the 14th day after admission;The proportion of inpatients / residents in ICU within 28 days;Frequency of serious adverse drug events; | — |
Countries
China
Contacts
Public ContactJianping Zhao
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed