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

Phase 4

Completed

• Conditions: COVID-19
• Interventions: Drug: Danoprevir+Ritonavir

• Registration Number: NCT04345276
• Lead Sponsor: Huoshenshan Hospital

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.

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-18
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-14
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Danoprevir+Ritonavir group	Danoprevir+Ritonavir	-

Primary Outcome Measures

Name	Time	Method
Rate of composite adverse outcomes	Within 10 days after administration	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

Secondary Outcome Measures

Name	Time	Method
Rate of ICU admission	Within 10 days after administration
Rate of serious adverse event	Within 10 days after administration
Rate of no dyspnea	Within 10 days after administration
Rate of mechanical ventilation	Within 10 days after administration
Time to recovery	Within 10 days after administration	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).
Rate of no fever	Within 10 days after administration
Rate of no cough	Within 10 days after administration
Rate of undetectable New coronavirus pathogen nucleic acid	Within 10 days after administration
Rate of no requiring supplemental oxygen	Within 10 days after administration

Trial Locations

Locations (1)

Huoshenshan Hostipal; 🇨🇳 Wuhan, Hubei, China