2019-nCoV Pneumonia Clinical Trial
Official title:
A Randomized,Open,Controlled Small Sample Clinical Study to Evaluate the Efficacy and Safety of ASC09/Ritonavir Compound Tablets and Ritonavir for 2019-nCoV Pneumonia
Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | July 1, 2020 |
| Est. primary completion date | May 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: 1. Age:18~55 years old, unlimited gender. 2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations. 3. Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days). 4. Women who have no planned pregnancy in the next six months,and are willing to take effective measures to prevent contraception from the first dose of study drug to 30 days after the last dose. 5. Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose. 6. Patients who voluntarily sign informed consent forms. Exclusion Criteria: 1.2019-nCoV severe Pneumonia patients. Meet the definition of severe pneumonia(Comply with any of the followings): 1. Respiratory distress ,RR=30 bpm; 2. In a resting state:SPO2=93%; 3. PaO2/ FiO2=300mmHg. 2.2019-nCoV critical and severe Pneumonia patients.Comply with any of the followings:Respiratory failure and need mechanical ventilation;Shock;Patients combined with other organ failure need ICU monitoring and treatment. 3.Severe liver disease(such as:the ChildPugh score=C;AST > 5 times the upper limit). 4.Patients who are allergic to the ingredients of ASC09/ritonavir compound tablets. 5.Patients with definite contraindications in ritonavir tablets. 6.Female subjects were positive for the pregnancy test during the screening period. 7.Researcher judges unsuitable for participation in this clinical trial(such as:during the study patients may be transferred to hospital for treatment;patients with multiple underlying diseases, etc) |
| Country | Name | City | State |
|---|---|---|---|
| China | Department and Institute of Infectious Disease | Wuhan | Hubei |
| Lead Sponsor | Collaborator |
|---|---|
| Tongji Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of comprehensive adverse outcome | The definition of comprehensive adverse outcome is as follows: SPO2=93% without oxygen inhalation; PaO2/FiO2=300mmHg; RR=30 bpm without oxygen inhalation. |
14 days | |
| Secondary | Time of clinical remission | The definition of clinical remission: Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours; There is no evidence of disease progression(New dyspnea, SpO2 decreased=3%,RR=30 bpm without oxygen inhalation). |
28 days | |
| Secondary | Rate of no fever | 14 days | ||
| Secondary | Rate of no cough | 14 days | ||
| Secondary | Rate of no dyspnea | 14 days | ||
| Secondary | Rate of no need for oxygen inhalation | 14 days | ||
| Secondary | Rate of undetectable viral RNA | 14 days | ||
| Secondary | Rate of mechanical ventilation | 28 days | ||
| Secondary | Rate of ICU admission | 28 days | ||
| Secondary | Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery | 28 days |