novel coronavirus pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Conventional standardized treatment and ASC09/Ritonavir
Control group:Conventional standardized treatment and Lopinavir/Ritonavir
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Patients with novel coronavirus infection pneumonia were confirmed by RT-PCR and clinical symptoms. The diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"; 3. Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days); 4. Women and partners who have no planned pregnancy within the past six months, and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration; 5. Agree not to participate in other clinical studies within 30 days from the first administration of the study drug to the last administration; 6. Patients who voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe 2019-nCoV pneumonia met one of the following conditions: respiratory distress, RR >= 30 times / min; or SaO2 / SpO2 = C, AST > 5 times upper limit); 4. Patients were allergic to the components of ASC09 / ritonavir compound tablets; 5. Patients with definite contraindications in the label of ritonavir tablets; 6. Female subjects pregnancy test was positive during the screening period; 7. Patients who are taking HIV protease inhibitor drugs; 8. Physician judged the patient was not suitable for this clinical trial (for example, patient may be transferred to another hospital during the study period; patient with multiple basic diseases, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of composite adverse outcome within 14 days after admission: Defined as (one of them) SPO2<= 93% without oxygen supplementation, PaO2/FiO2 <= 300mmHg or RR <=30 breaths per minute.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical recovery rate and time.;Rate of no fever within 14 days after admission.;Rate of no cough within 14 days after admission.;Rate of no dyspnea within 14 days after admission.;Rate of no requring supplemental oxygen within 14 days after admission.;Rate of undectable viral RNA within 14 days after admission.;Rate of mechanical ventilation within 14 days after admission.;Rate of ICU admission within 14 days after admission.;Rate and time of laboratory indicators related to disease improvement to return to normal, within 14 days after admission.; | — |
Countries
China
Contacts
Public ContactQiu Yunqing
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed