Coronavirus disease 2019,COVID-19
Conditions
Interventions
Test group:Leritrelvir Tablets
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. sign the informed consent form before the study, and fully understand the study content, process and possible adverse reactions; 2. age = 18 years (inclusive), gender not limited; 3. symptoms: at least 1 of the following 11 symptoms: nasal congestion or runny nose, sore throat, shortness of breath or dyspnea, cough, muscle or body pain, headache, chills, fever, nausea, vomiting, diarrhea. 4. Ct value = 30 for novel coronavirus nucleic acid test (QPCR, Ct value = 30 for ORF1ab gene or N gene); 5. Inpatients with mild or moderate novel coronavirus infection confirmed by nasopharyngeal swab test within 120 h prior to enrollment and without any high risk factors; 6. inpatients with mild or moderate novel coronavirus infection with any of the high-risk risk factors and with onset (at least one of the 11 symptoms) for more than 5 days (not included); 7. Inpatients with heavy novel coronavirus infection. In acordance with any of the following: 1) respiratory distress with RR = 30 beats/min; 2) resting state with finger oxygen saturation = 93%; 3) arterial partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) = 300 mmHg; progressive worsening of clinical symptoms and lung imaging showing significant progression of > 50% of the lesion within 24-48 hours; 8. agree to take effective contraceptive measures during the whole study period and within 3 months after drug withdraw;
Exclusion criteria
Exclusion criteria: 1. patients with hypersensitivity to the components of Leretuvir tablets or any of the excipients; 2. inpatients with mild or moderate novel coronavirus infections within 5 days of onset in a population with any of the high-risk risk factors; the high-risk risk factors are: age = 65 years; not vaccinated against neocolonial; having chronic diseases (cardiovascular disease, renal disease, respiratory disease, diabetes, neurocognitive disorders, etc.); people with various forms of immunosuppression (tumor radiotherapy, organ or hematopoietic stem cell transplantation, congenital immunodeficiency HIV infection, hormone/immunosuppressant/biologic users, etc.); obesity (BMI = 30). 3. patients with severe kidney injury (Ccr <30 mL/min); 4. patients with psychiatric disorders; 5. patients with coma, dysphagia; 6. significant liver function abnormalities (ALT or AST = 10 ULN, or total bilirubin = 2 ULN) during screening 7. patients with uncontrolled HIV-1 infection; 8. patients who are positive for influenza virus; 9. those vaccinated within 28 days prior to enrollment and those scheduled to be vaccinated during the study period 10. pregnant or lactating women or those with positive pregnancy tests; 11. those enrolled and receiving other clinical trial drugs within 1 month prior to dosing 12. poor compliance and inability to cooperate in completing the trial; 13. Other conditions that the physician considers unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of disease progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of recovery from clinical symptoms;Symptom recovery rate;Proportion of clinical staging progression;All-cause mortality;Proportion of subjects enrolled in ICU for treatment;Length of hospitalization;First Time of SARS-CoV-2 virus nucleic acid turning negative;Rate of nucleic acid turning negative;Change in RNA load from baseline; | — |
Countries
China
Contacts
Public ContactLiu Xiaoqing
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed