novel coronavirus pneumonia (COVID-19)
Conditions
Interventions
A:BaloxavirMarboxil:80mg on day1,80mg on day4
and 80mg on day7 as neccessary. No more than 3 times administration in total.BaloxavirMarboxil:80mg on day1,80mg on day4
and 80mg on day7 as neccessary. No more than 3 times administration in total.
B:Favipiravir: 600 mg tid with 1600mg first loading dosage for no more than 14 days.
C:Lopinavir-Ritonavir: 2# (200mg/50 mg), twice daily, for 14days.
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years male or female, willing to sign the 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. Enrollment and initiation of study drug treatment <=96 hours after onset of symptoms; 4. No difficulty in swallowing the pills; 5. Willing to abide by the protocol.
Exclusion criteria
Exclusion criteria: 1. Hypersensitive to study drug; 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. Pregnancy or breastfeeding,or positive pregnancy test in a predose examination, or have a plan to be pregnant within 3 months after the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to viral negativityby RT-PCR;Time to clinical improvement: Time from start of study drug to hospital discharge or to NEWS2<2 for 24 hours.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of mechanical ventilation by day7, day14;Incidence of ICU admission by day7, day14;Time to treatment failure, determined as death, mechanical ventilation or ICU admission;All-cause mortality by day14, day28;Incidence of complications;Incidence and duration of antibiotic treatment;The number (proportion) of subjects with viral positiveby RT-PCR by day7, day14;Safety assessment according to AE, clinical laboratory examination, ECG and vital signs, etc.; | — |
Countries
China
Contacts
Public ContactYunqing Qiu
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed