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

NCT ID: NCT04345276

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-18
• Study Completion Date: 2020-04-15

Brief Summary

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

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.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Danoprevir+Ritonavir group

Group Type: EXPERIMENTAL

Danoprevir+Ritonavir

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ganovo

Eligibility 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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Huoshenshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yahong Chen, MD

Role: STUDY_DIRECTOR

Ascletis Pharmaceuticals Co., Ltd.

Locations

Huoshenshan Hostipal

Wuhan, Hubei, China

Countries

China

Other Identifiers

ASC-CTP-HS-01

Identifier Type: -

Identifier Source: org_study_id