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

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Danoprevir+Ritonavir

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 18-75 years old;
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);
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 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);
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;
Severe liver disease (such as child Pugh score ≥C, AST > 5 times upper limit);
Patients with contraindications specified in the instructions of danoprevir and ritonavir tablets;
Patients who plan to take protease inhibitors other than danoprevir and ritonavir simultaneously during the trial.
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.).

Sites / Locations

Huoshenshan Hostipal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Danoprevir+Ritonavir group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Rate of no fever

Rate of no cough

Rate of no dyspnea

Rate of no requiring supplemental oxygen

Rate of undetectable New coronavirus pathogen nucleic acid

Rate of mechanical ventilation

Rate of ICU admission

Rate of serious adverse event

Full Information

NCT ID

NCT04345276

First Posted

April 10, 2020

Last Updated

June 1, 2020

Sponsor

Huoshenshan Hospital

Collaborators

Ascletis Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04345276

Brief Title

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

Official Title

An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 18, 2020 (Actual)

Primary Completion Date

April 15, 2020 (Actual)

Study Completion Date

April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Huoshenshan Hospital

Collaborators

Ascletis Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Danoprevir+Ritonavir group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Danoprevir+Ritonavir

Other Intervention Name(s)

Ganovo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of composite adverse outcomes

Description

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

Time Frame