Clinical trial NCT04345276: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Huoshenshan Hospital
Sponsor class: OTHER
Collaborators: name: Ascletis Pharmaceuticals Co., Ltd.
First posted: 2020-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: Rate of composite adverse outcomes
timeFrame: Within 10 days after administration
Secondary outcomes:
measure: Time to recovery
timeFrame: Within 10 days after administration
measure: Rate of no fever
timeFrame: Within 10 days after administration
measure: Rate of no cough
timeFrame: Within 10 days after administration
measure: Rate of no dyspnea
timeFrame: Within 10 days after administration
measure: Rate of no requiring supplemental oxygen
timeFrame: Within 10 days after administration
measure: Rate of undetectable New coronavirus pathogen nucleic acid
timeFrame: Within 10 days after administration
measure: Rate of mechanical ventilation
timeFrame: Within 10 days after administration
measure: Rate of ICU admission
timeFrame: Within 10 days after administration
measure: Rate of serious adverse event
timeFrame: Within 10 days after administration
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huoshenshan Hostipal
state: Hubei
Study officials:
affiliation: Ascletis Pharmaceuticals Co., Ltd.
name: Yahong Chen, MD
role: STUDY_DIRECTOR
References: