novel coronavirus pneumonia (COVID-19)
Conditions
Interventions
Experimental group 1:current antiviral treatment+Baloxavir Marboxil tablets
Experimental group 2:current antiviral treatment+fabiravir tablets
Control group:current antiviral treatment
Sponsors
The First Hospital Affiliated to Zhejiang University's Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years of age, male or female, willing to sign informed consent; 2. Tested positive for novel coronavirus infection after the onset of symptoms using a real time polymerase chain reaction (RT-PCR)-based diagnostic assay; 3. At least 2 viral nucleic acid tests are still positive under current antiviral therapy; 4. No difficulty in swallowing the pills; 5. Willing to abide by the protocol.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, known to be allergic to balosavir or farpiravir or pharmaceutical excipients; 2. Body weight <40 kg; 3. Considered as severe disease: has an ongoing respiratory deficiency and subjected to invasive mechanical ventilation; or presence of shock; or admitted to the ICU due to complications; 4. Has known kidney dysfunction determined as CLcr<60 mL/min; 5. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal; or increase in ALT or AST is more than 3 ULN and increase in total bilirubin more than 2 ULN; 6. In the investigator's judgment, there are other factors that may cause the subject to be forced to terminate the study, such as other serious illnesses, serious laboratory abnormalities, and other factors that may affect the safety of the subject or the collection of test data and blood samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to viral negativity by RT-PCR;Time to clinical improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| ncidence of mechanical ventilation by day14;Incidence of ICU admission by day14;Time to treatment failure;All-cause mortality by day14, day28;The number (proportion) of subjects with viral positive by RT-PCR;Safety assessment according to AE, clinical laboratory examination, ECG and vital signs, etc.; | — |
Countries
China
Contacts
Public ContactQiu Yunqing
The First Hospital Affiliated to Zhejiang University's Medical School
Outcome results
None listed