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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291729
• Other study ID #: ASC-CTP-NC-01
• Status: Completed
• Phase: Phase 4
• Start date: February 17, 2020
• Est. completion date: March 19, 2020

Study information

• Verified date: March 2020
• Source: The Ninth Hospital of Nanchang
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Drug:
• Ganovo+ritonavir+/-Interferon nebulization
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.

Locations

Country	Name	City	State
China	The Ninth Hospital of Nanchang	Nanchang	Jiangxi

Sponsors (2)

Lead Sponsor	Collaborator
The Ninth Hospital of Nanchang	Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of composite adverse outcomes	Defined as SPO2= 93% without oxygen supplementation, PaO2/FiO2 =300mmHg or a respiratory rate =30 breaths per min without supplemental oxygen	14 days
Secondary	Time to recovery	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).	14 days
Secondary	Rate of no fever	Rate of no fever	14 days
Secondary	Rate of no cough	Rate of no cough	14 days
Secondary	Rate of no dyspnea	Rate of no dyspnea	14 days
Secondary	Rate of no requiring supplemental oxygen	Rate of no requiring supplemental oxygen	14 days
Secondary	Rate of undetectable New coronavirus pathogen nucleic acid	Rate of undetectable New coronavirus pathogen nucleic acid	14 days
Secondary	Rate of mechanical ventilation	Rate of mechanical ventilation	14 days
Secondary	Rate of ICU admission	Rate of ICU admission	14 days
Secondary	Rate of serious adverse event	Rate of serious adverse event	14 days