Official Title
A Randomized,Open,Controlled Small Sample Clinical Study to Evaluate the Efficacy and Safety of ASC09/Ritonavir Compound Tablets and Ritonavir for 2019-nCoV Pneumonia
Brief Summary

Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.

Unknown status
2019-nCoV Pneumonia

Drug: ASC09F+Oseltamivir

ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day

Drug: Ritonavir+Oseltamivir

Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day

Drug: Oseltamivir

75mg ,once a day

Eligibility Criteria

Inclusion Criteria:

1. Age:18~55 years old, unlimited gender.

2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical
manifestations.

3. Patients with newly diagnosed respiratory discomfort who have been hospitalized (The
proper diagnosis time is less than 7 days).

4. Women who have no planned pregnancy in the next six months,and are willing to take
effective measures to prevent contraception from the first dose of study drug to 30
days after the last dose.

5. Agree not to participate in other clinical studies within 30 days from the first dose
of the study drug to the last dose.

6. Patients who voluntarily sign informed consent forms.

Exclusion Criteria:

1.2019-nCoV severe Pneumonia patients.

Meet the definition of severe pneumonia(Comply with any of the followings):

1. Respiratory distress ,RR≥30 bpm;

2. In a resting state:SPO2≤93%;

3. PaO2/ FiO2≤300mmHg.

2.2019-nCoV critical and severe Pneumonia patients.Comply with any of the
followings:Respiratory failure and need mechanical ventilation;Shock;Patients combined
with other organ failure need ICU monitoring and treatment.

3.Severe liver disease(such as:the ChildPugh score≥C;AST > 5 times the upper limit).

4.Patients who are allergic to the ingredients of ASC09/ritonavir compound tablets.

5.Patients with definite contraindications in ritonavir tablets.

6.Female subjects were positive for the pregnancy test during the screening period.

7.Researcher judges unsuitable for participation in this clinical trial(such as:during
the study patients may be transferred to hospital for treatment;patients with multiple
underlying diseases, etc)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Countries
China
Locations

Department and Institute of Infectious Disease
Wuhan, Hubei, China

Investigator: Qin Ning, professor
qning@vip.sina.com

Contacts

Qing Ning, Professor
+8613971521450
qning@vip.sina.com

Meifang Han, Professor
+8613986093605
mfhan@foxmail.com

Tongji Hospital
NCT Number
MeSH Terms
Pneumonia
Ritonavir
Oseltamivir