Clinical trial NCT04291729: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: The Ninth Hospital of Nanchang
Sponsor class: OTHER
Collaborators: name: Ascletis Pharmaceuticals Co., Ltd.
First posted: 2020-03-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: Rate of composite adverse outcomes
timeFrame: 14 days
Secondary outcomes:
measure: Time to recovery
timeFrame: 14 days
measure: Rate of no fever
timeFrame: 14 days
measure: Rate of no cough
timeFrame: 14 days
measure: Rate of no dyspnea
timeFrame: 14 days
measure: Rate of no requiring supplemental oxygen
timeFrame: 14 days
measure: Rate of undetectable New coronavirus pathogen nucleic acid
timeFrame: 14 days
measure: Rate of mechanical ventilation
timeFrame: 14 days
measure: Rate of ICU admission
timeFrame: 14 days
measure: Rate of serious adverse event
timeFrame: 14 days
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Ninth Hospital of Nanchang
state: Jiangxi
Study officials:
affiliation: Ascletis Pharmaceuticals Co., Ltd.
name: Yahong Chen, MD
role: STUDY_DIRECTOR
References: