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Completed

NCT Number: NCT04291729

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

Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ninth Hospital of Nanchang

Nanchang, Jiangxi, 330000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Ganovo+ritonavir+/-Interferon nebulization

Drug

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 outcomes

  1. Rate of composite adverse outcomes

    Time frame: 14 days

    Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen

Secondary outcomes

  1. Time to recovery

    Time frame: 14 days

    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).

  2. Rate of no fever

    Time frame: 14 days

    Rate of no fever

  3. Rate of no cough

    Time frame: 14 days

    Rate of no cough

  4. Rate of no dyspnea

    Time frame: 14 days

    Rate of no dyspnea

  5. Rate of no requiring supplemental oxygen

    Time frame: 14 days

    Rate of no requiring supplemental oxygen

  6. Rate of undetectable New coronavirus pathogen nucleic acid

    Time frame: 14 days

    Rate of undetectable New coronavirus pathogen nucleic acid

  7. Rate of mechanical ventilation

    Time frame: 14 days

    Rate of mechanical ventilation

  8. Rate of ICU admission

    Time frame: 14 days

    Rate of ICU admission

  9. Rate of serious adverse event

    Time frame: 14 days

    Rate of serious adverse event

Sponsors and collaborators

Lead sponsor

The Ninth Hospital of Nanchang

Other

Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

Registry information

Official study title

An Open Clinical Trial to Evaluate Ganovo(Danoprevir ) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2020
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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