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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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2019-nCoV

Intervention / Treatment
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* Drug: ASC09/ritonavir group
* Drug: lopinavir/ritonavir group


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC09/ritonavir group<br>ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment | Drug: ASC09/ritonavir group<br>* ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment<br>|
| Active Comparator: lopinavir/ritonavir group<br>Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment | Drug: lopinavir/ritonavir group<br>* Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of composite adverse outcome | Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA. | 14 days | 
| Rate of no fever |  | 14 days | 
| Rate of no cough |  | 14 days | 
| Rate of no dyspnea |  | 14 days | 
| Rate of no requring supplemental oxygen |  | 14 days | 
| Rate of undectable viral RNA |  | 14 days | 
| Rate of mechanical ventilation |  | 14 days | 
| Rate of ICU admission |  | 14 days | 
| Time and rate of laboratory indicators related to disease improvement to return to normal |  | 14 days |