Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection

A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection

Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.

Inclusion Criteria:

• 1. Aged between 18 and 75 years, extremes included, male or female
• 2. Laboratory (RT-PCR) and clinical symptoms confirmed case of 2019-nCoV pneumonia, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"
• 3. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
• 4. No family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose
• 5. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study
• 6. Informed Consent Form (ICF) signed voluntarily

Exclusion Criteria:

• 1. Severe 2019-nCoV pneumonia met one of the following criteria: respiratory distress, RR ≥ 30 times / min, or SaO2 / SpO2 ≤ 93% in resting state, or arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg (1mmHg = 0.133kpa)
• 2. Critical severe 2019-nCoV pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required ICU monitoring treatment
• 3. Severe liver disease (e.g. Child Pugh score ≥ C, AST > 5 times upper limit)
• 4. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets
• 5. Patients with definite contraindications in the label of ritonavir
• 6. Positive serum pregnancy test result for women with childbearing potential at screening
• 7. Using HIV protease inhibitor drugs
• 8. Not suitable for the study, in the opinion of the Investigator (e.g. patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.)