Back to resultsEvaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ganovo+ritonavir+/-Interferon nebulization
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Aged 18-75 years old;
- Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (Current Trial Version);
- Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days);
- Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration;
- Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration;
- Patients who voluntarily sign informed consent.
Exclusion Criteria:
- The pneumonia patients with severe new coronavirus infection met one of the following conditions: 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);
- Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment;
- Severe liver disease (such as child Pugh score >=C, AST > 5 times upper limit);
- Patients with contraindications specified in the instructions of ritonavir tablets;
- The pregnancy test of female subjects in the screening period was positive;
- The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
Sites / Locations
- The Ninth Hospital of Nanchang
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ganovo+ritonavir with or without interferon nebulization
Arm Description
Outcomes
Primary Outcome Measures
Rate of composite adverse outcomes
Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen
Secondary Outcome Measures
Time to recovery
Clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough, diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen).
Rate of no fever
Rate of no fever
Rate of no cough
Rate of no cough
Rate of no dyspnea
Rate of no dyspnea
Rate of no requiring supplemental oxygen
Rate of no requiring supplemental oxygen
Rate of undetectable New coronavirus pathogen nucleic acid
Rate of undetectable New coronavirus pathogen nucleic acid
Rate of mechanical ventilation
Rate of mechanical ventilation
Rate of ICU admission
Rate of ICU admission
Rate of serious adverse event
Rate of serious adverse event
Full Information
NCT ID
NCT04291729
First Posted
February 27, 2020
Last Updated
April 9, 2020
Sponsor
The Ninth Hospital of Nanchang
Collaborators
Ascletis Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04291729
Brief Title
Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Official Title
An Open Clinical Trial to Evaluate Ganovo（Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
March 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Ninth Hospital of Nanchang
Collaborators
Ascletis Pharmaceuticals Co., Ltd.
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
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Detailed Description
Given no specific antiviral therapies for new coronavirus pneumonia approved yet and Ganovo, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Ganovo in hospitalized patients infected with SARS-CoV-2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ganovo+ritonavir with or without interferon nebulization
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ganovo+ritonavir+/-Interferon nebulization
Intervention Description
Ganovo one tablet (100mg / tablet) at a time, twice a day, up to 14 days. Ritonavir one tablet(100mg / tablet) at a time, twice a day, up to 14 days.With or without spray inhalation of interferon, 50μg / time for adults, twice a day up to 14 days.
Primary Outcome Measure Information:
Title
Rate of composite adverse outcomes
Description
Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time to recovery
Description
Clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough, diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen).
Time Frame
14 days
Title
Rate of no fever
Description
Rate of no fever
Time Frame
14 days
Title
Rate of no cough
Description
Rate of no cough
Time Frame
14 days
Title
Rate of no dyspnea
Description
Rate of no dyspnea
Time Frame
14 days
Title
Rate of no requiring supplemental oxygen
Description
Rate of no requiring supplemental oxygen
Time Frame
14 days
Title
Rate of undetectable New coronavirus pathogen nucleic acid
Description
Rate of undetectable New coronavirus pathogen nucleic acid
Time Frame
14 days
Title
Rate of mechanical ventilation
Description
Rate of mechanical ventilation
Time Frame
14 days
Title
Rate of ICU admission
Description
Rate of ICU admission
Time Frame
14 days
Title
Rate of serious adverse event
Description
Rate of serious adverse event
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-75 years old;
Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (Current Trial Version);
Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days);
Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration;
Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration;
Patients who voluntarily sign informed consent.
Exclusion Criteria:
The pneumonia patients with severe new coronavirus infection met one of the following conditions: 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);
Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment;
Severe liver disease (such as child Pugh score >=C, AST > 5 times upper limit);
Patients with contraindications specified in the instructions of ritonavir tablets;
The pregnancy test of female subjects in the screening period was positive;
The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yahong Chen, MD
Organizational Affiliation
Ascletis Pharmaceuticals Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
The Ninth Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
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