Back to resultsA Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
Primary Purpose
2019-nCoV Pneumonia
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ASC09F+Oseltamivir
Ritonavir+Oseltamivir
Oseltamivir
Sponsored by
About this trial
This is an interventional treatment trial for 2019-nCoV Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Age:18~55 years old, unlimited gender.
- Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations.
- Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days).
- 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.
- Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose.
- 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):
- Respiratory distress ,RR≥30 bpm;
- In a resting state:SPO2≤93%;
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)
Sites / Locations
- Department and Institute of Infectious DiseaseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ASC09F+Oseltamivir
Ritonavir+Oseltamivir
Oseltamivir
Arm Description
Outcomes
Primary Outcome Measures
Rate of comprehensive adverse outcome
The definition of comprehensive adverse outcome is as follows:
SPO2≤93% without oxygen inhalation;
PaO2/FiO2≤300mmHg;
RR≥30 bpm without oxygen inhalation.
Secondary Outcome Measures
Time of clinical remission
The definition of clinical remission:
Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours;
There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation).
Rate of no fever
Rate of no cough
Rate of no dyspnea
Rate of no need for oxygen inhalation
Rate of undetectable viral RNA
Rate of mechanical ventilation
Rate of ICU admission
Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04261270
Brief Title
A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
2019-nCoV Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASC09F+Oseltamivir
Arm Type
Experimental
Arm Title
Ritonavir+Oseltamivir
Arm Type
Experimental
Arm Title
Oseltamivir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASC09F+Oseltamivir
Intervention Description
ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
Intervention Type
Drug
Intervention Name(s)
Ritonavir+Oseltamivir
Intervention Description
Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Intervention Description
75mg ,once a day
Primary Outcome Measure Information:
Title
Rate of comprehensive adverse outcome
Description
The definition of comprehensive adverse outcome is as follows:
SPO2≤93% without oxygen inhalation;
PaO2/FiO2≤300mmHg;
RR≥30 bpm without oxygen inhalation.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time of clinical remission
Description
The definition of clinical remission:
Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours;
There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation).
Time Frame
28 days
Title
Rate of no fever
Time Frame
14 days
Title
Rate of no cough
Time Frame
14 days
Title
Rate of no dyspnea
Time Frame
14 days
Title
Rate of no need for oxygen inhalation
Time Frame
14 days
Title
Rate of undetectable viral RNA
Time Frame
14 days
Title
Rate of mechanical ventilation
Time Frame
28 days
Title
Rate of ICU admission
Time Frame
28 days
Title
Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age:18~55 years old, unlimited gender.
Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations.
Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days).
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.
Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose.
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):
Respiratory distress ,RR≥30 bpm;
In a resting state:SPO2≤93%;
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Ning, Professor
Phone
+8613971521450
Email
qning@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meifang Han, Professor
Phone
+8613986093605
Email
mfhan@foxmail.com
Facility Information:
Facility Name
Department and Institute of Infectious Disease
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Ning, professor
Email
qning@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Meifang Han, professor
Email
mfhan@foxmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
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