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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345276
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Collaborator:
Ascletis Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Huoshenshan Hospital

Brief Summary:
Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Danoprevir+Ritonavir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Actual Study Start Date : March 18, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir

Arm Intervention/treatment
Experimental: Danoprevir+Ritonavir group 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. Rate of no fever [ Time Frame: Within 10 days after administration ]
  3. Rate of no cough [ Time Frame: Within 10 days after administration ]
  4. Rate of no dyspnea [ Time Frame: Within 10 days after administration ]
  5. Rate of no requiring supplemental oxygen [ Time Frame: Within 10 days after administration ]
  6. Rate of undetectable New coronavirus pathogen nucleic acid [ Time Frame: Within 10 days after administration ]
  7. Rate of mechanical ventilation [ Time Frame: Within 10 days after administration ]
  8. Rate of ICU admission [ Time Frame: Within 10 days after administration ]
  9. Rate of serious adverse event [ Time Frame: Within 10 days after administration ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345276


Contacts
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Contact: Junxue Wang, MD 8618917387623 docd1@sina.com
Contact: Bo Wei, MD 8615921231996 weibo0816@163.com

Locations
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China, Hubei
Huoshenshan Hostipal Recruiting
Wuhan, Hubei, China, 430104
Contact: Junxue Wang, MD    8618917387623    docd1@sina.com   
Contact: Bo Wei, MD    8615921231996    weibo0816@163.co   
Sponsors and Collaborators
Huoshenshan Hospital
Ascletis Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Yahong Chen, MD Ascletis Pharmaceuticals Co., Ltd.
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Responsible Party: Huoshenshan Hospital
ClinicalTrials.gov Identifier: NCT04345276    
Other Study ID Numbers: ASC-CTP-HS-01
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors