Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
75mg ,once a day
Department and Institute of Infectious Disease
Wuhan, Hubei, China
RECRUITINGRate of comprehensive adverse outcome
The definition of comprehensive adverse outcome is as follows: 1. SPO2≤93% without oxygen inhalation; 2. PaO2/FiO2≤300mmHg; 3. RR≥30 bpm without oxygen inhalation.
Time frame: 14 days
Time of clinical remission
The definition of clinical remission: 1. Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours; 2. There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation).
Time frame: 28 days
Rate of no fever
Time frame: 14 days
Rate of no cough
Time frame: 14 days
Rate of no dyspnea
Time frame: 14 days
Rate of no need for oxygen inhalation
Time frame: 14 days
Rate of undetectable viral RNA
Time frame: 14 days
Rate of mechanical ventilation
Time frame: 28 days
Rate of ICU admission
Time frame: 28 days
Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery
Time frame: 28 days
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