Efficacy and Safety 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 Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345276
• Other study ID #: ASC-CTP-HS-01
• Status: Completed
• Phase: Phase 4
• Start date: March 18, 2020
• Est. completion date: April 15, 2020

Study information

• Verified date: March 2020
• Source: Huoshenshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

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.

Locations

Country	Name	City	State
China	Huoshenshan Hostipal	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huoshenshan Hospital	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 min without supplemental oxygen	Within 10 days after administration
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 = 30 breaths per min without supplemental oxygen).	Within 10 days after administration
Secondary	Rate of no fever		Within 10 days after administration
Secondary	Rate of no cough		Within 10 days after administration
Secondary	Rate of no dyspnea		Within 10 days after administration
Secondary	Rate of no requiring supplemental oxygen		Within 10 days after administration
Secondary	Rate of undetectable New coronavirus pathogen nucleic acid		Within 10 days after administration
Secondary	Rate of mechanical ventilation		Within 10 days after administration
Secondary	Rate of ICU admission		Within 10 days after administration
Secondary	Rate of serious adverse event		Within 10 days after administration