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Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

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ClinicalTrials.gov Identifier: NCT04345276
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
Ascletis Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Huoshenshan Hospital

Tracking Information
First Submitted Date  ICMJE April 10, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE March 18, 2020
Actual Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • 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).
  • Rate of no fever [ Time Frame: Within 10 days after administration ]
  • Rate of no cough [ Time Frame: Within 10 days after administration ]
  • Rate of no dyspnea [ Time Frame: Within 10 days after administration ]
  • Rate of no requiring supplemental oxygen [ Time Frame: Within 10 days after administration ]
  • Rate of undetectable New coronavirus pathogen nucleic acid [ Time Frame: Within 10 days after administration ]
  • Rate of mechanical ventilation [ Time Frame: Within 10 days after administration ]
  • Rate of ICU admission [ Time Frame: Within 10 days after administration ]
  • Rate of serious adverse event [ Time Frame: Within 10 days after administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Official Title  ICMJE An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Brief Summary Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Danoprevir+Ritonavir
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 Name: Ganovo
Study Arms  ICMJE Experimental: Danoprevir+Ritonavir group
Intervention: Drug: Danoprevir+Ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
40
Actual Study Completion Date  ICMJE April 15, 2020
Actual Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 18-75 years old;
  2. 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);
  3. Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days);
  4. 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;
  5. Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration;
  6. Patients who voluntarily sign informed consent.

Exclusion Criteria:

  1. 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);
  2. 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;
  3. Severe liver disease (such as child Pugh score ≥C, AST > 5 times upper limit);
  4. Patients with contraindications specified in the instructions of danoprevir and ritonavir tablets;
  5. Patients who plan to take protease inhibitors other than danoprevir and ritonavir simultaneously during the trial.
  6. The pregnancy test of female subjects in the screening period was positive;
  7. 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.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04345276
Other Study ID Numbers  ICMJE ASC-CTP-HS-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Huoshenshan Hospital
Study Sponsor  ICMJE Huoshenshan Hospital
Collaborators  ICMJE Ascletis Pharmaceuticals Co., Ltd.
Investigators  ICMJE
Study Director: Yahong Chen, MD Ascletis Pharmaceuticals Co., Ltd.
PRS Account Huoshenshan Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP