Official Title
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
Brief Summary

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.

Terminated
2019-nCoV

Drug: ASC09/ritonavir group

ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment

Drug: lopinavir/ritonavir group

Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment

Eligibility Criteria

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.)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
China
Locations

The first affiliated hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang Province, P.R. China, China

Yunqing Qiu, Master, Principal Investigator
First Affiliated Hospital of Zhejiang University

Ascletis Pharmaceuticals Co., Ltd.
NCT Number
MeSH Terms
Coronavirus Infections
Ritonavir
Lopinavir