A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia

Tongji Hospital

Status and phase: Unknown; Phase 3

Conditions: 2019-nCoV Pneumonia

Treatments: Drug: Oseltamivir; Drug: ASC09F+Oseltamivir; Drug: Ritonavir+Oseltamivir

Study type: Interventional

Funder types: Other

Identifiers

NCT04261270

ASC09F-CTP-TJ-01

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

ASC09F+Oseltamivir

Experimental group

Treatment:

Drug: ASC09F+Oseltamivir

Ritonavir+Oseltamivir

Experimental group

Treatment:

Drug: Ritonavir+Oseltamivir

Oseltamivir

Experimental group

Treatment:

Drug: Oseltamivir