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

Phase 3

• Conditions: 2019-nCoV Pneumonia
• Interventions: Drug: ASC09F+Oseltamivir; Drug: Ritonavir+Oseltamivir; Drug: Oseltamivir

• Registration Number: NCT04261270
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-14
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-05-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASC09F+Oseltamivir	ASC09F+Oseltamivir	-
Ritonavir+Oseltamivir	Ritonavir+Oseltamivir	-
Oseltamivir	Oseltamivir	-

Primary Outcome Measures

Name	Time	Method
Rate of comprehensive adverse outcome	14 days	The definition of comprehensive adverse outcome is as follows: 1. SPO2≤93% without oxygen inhalation; 2. PaO2/FiO2≤300mmHg; 3. RR≥30 bpm without oxygen inhalation.

Secondary Outcome Measures

Name	Time	Method
Time of clinical remission	28 days	The definition of clinical remission: 1. Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours; 2. There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation).
Rate of no fever	14 days
Rate of no cough	14 days
Rate of no dyspnea	14 days
Rate of no need for oxygen inhalation	14 days
Rate of undetectable viral RNA	14 days
Rate of mechanical ventilation	28 days
Rate of ICU admission	28 days
Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery	28 days

Trial Locations

Locations (1)

Department and Institute of Infectious Disease; 🇨🇳 Wuhan, Hubei, China