- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345276
Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
June 1, 2020 updated by: Huoshenshan Hospital
An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
Study Overview
Detailed Description
Given no specific antiviral therapies for COVID-19 approved yet and Danoprevir sodium tablet, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Danoprevir sodium tablet in hospitalized patients infected with SARS-CoV-2.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430104
- Huoshenshan Hostipal
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18-75 years old;
- Pneumonia patients with SARS-CoV-2 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 SARS-CoV-2 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 SARS-CoV-2 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 SARS-CoV-2 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 danoprevir and ritonavir tablets;
- Patients who plan to take protease inhibitors other than danoprevir and ritonavir simultaneously during the trial.
- 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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Danoprevir+Ritonavir group
|
Danoprevir 100mg , one tablet each time , twice per day, up to 10 days.
Ritonavir 100mg, one tablet each time , twice per day, up to 10 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of composite adverse outcomes
Time Frame: Within 10 days after administration
|
Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen min without supplemental oxygen
|
Within 10 days after administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to recovery
Time Frame: Within 10 days after administration
|
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 ≥ 30 breaths per min without supplemental oxygen).
|
Within 10 days after administration
|
Rate of no fever
Time Frame: Within 10 days after administration
|
Within 10 days after administration
|
|
Rate of no cough
Time Frame: Within 10 days after administration
|
Within 10 days after administration
|
|
Rate of no dyspnea
Time Frame: Within 10 days after administration
|
Within 10 days after administration
|
|
Rate of no requiring supplemental oxygen
Time Frame: Within 10 days after administration
|
Within 10 days after administration
|
|
Rate of undetectable New coronavirus pathogen nucleic acid
Time Frame: Within 10 days after administration
|
Within 10 days after administration
|
|
Rate of mechanical ventilation
Time Frame: Within 10 days after administration
|
Within 10 days after administration
|
|
Rate of ICU admission
Time Frame: Within 10 days after administration
|
Within 10 days after administration
|
|
Rate of serious adverse event
Time Frame: Within 10 days after administration
|
Within 10 days after administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2020
Primary Completion (Actual)
April 15, 2020
Study Completion (Actual)
April 15, 2020
Study Registration Dates
First Submitted
April 10, 2020
First Submitted That Met QC Criteria
April 10, 2020
First Posted (Actual)
April 14, 2020
Study Record Updates
Last Update Posted (Actual)
June 2, 2020
Last Update Submitted That Met QC Criteria
June 1, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
Other Study ID Numbers
- ASC-CTP-HS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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