COVID-19
Conditions
Brief summary
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Detailed description
Given no specific antiviral therapies for new coronavirus pneumonia approved yet and Ganovo, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Ganovo in hospitalized patients infected with SARS-CoV-2.
Interventions
DRUGGanovo+ritonavir+/-Interferon nebulization
Ganovo one tablet (100mg / tablet) at a time, twice a day, up to 14 days. Ritonavir one tablet(100mg / tablet) at a time, twice a day, up to 14 days.With or without spray inhalation of interferon, 50μg / time for adults, twice a day up to 14 days.
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
The Ninth Hospital of Nanchang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-75 years old; * Pneumonia patients with new coronavirus 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 new coronavirus 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 new coronavirus 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 new coronavirus 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 ritonavir tablets; * 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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of composite adverse outcomes | 14 days | Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of no fever | 14 days | Rate of no fever |
| Rate of no cough | 14 days | Rate of no cough |
| Rate of no dyspnea | 14 days | Rate of no dyspnea |
| Rate of no requiring supplemental oxygen | 14 days | Rate of no requiring supplemental oxygen |
| Time to recovery | 14 days | 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 ≥ 24 breaths per min without supplemental oxygen). |
| Rate of mechanical ventilation | 14 days | Rate of mechanical ventilation |
| Rate of ICU admission | 14 days | Rate of ICU admission |
| Rate of serious adverse event | 14 days | Rate of serious adverse event |
| Rate of undetectable New coronavirus pathogen nucleic acid | 14 days | Rate of undetectable New coronavirus pathogen nucleic acid |
Countries
China
Outcome results
None listed