COVID-19
Conditions
Interventions
VV116 group:VV116+standard treatment
control group:palcebo+standard treatment
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)>= 18 years old (2)meet the clinical diagnosis of COVID-19, and the onset of symptoms >= 5 days (3)the Ct value of SARS-CoV-2 (O gene or N gene) reverse-transcriptase–polymerase-chain-reaction test = 5 half-lives (PAXLOVID >= 48h, Azifudine >= 72h) (6)volunteered to participate in this study and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: (1)life expectancy 3 ULN (4)received antiviral treatment for diseases like AIDS (5)received a SARS-CoV-2 monoclonal antibody treatment, but not include Tozumab and Baritinib (6)received convalescent COVID-19 plasma treatment (7)diseases (eg: Malignant tumors, stroke, acute myocardial infarction)in the period of rapid deterioration and progress (8)participated in a clinical study involving an investigational intervention within the last 30 days. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed (9)pregnant or breast-feeding or plan to be pregnant and male whose wife or partner plan to be pregnant within this study period (10)have a severe mental illness or any condition, which in the opinion of the investigator, will compromise the safety of the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality;survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| WHO Clinical Progression Scale rating;the time of nucleic acid test turned negative;the time of mechanical ventilation;the time of ECMO;Duration of hospitalization;discharge rate;the rate of AE ,SAE;Proportion of subjects whose disease turned to moderate from severe or critical illness; | — |
Countries
China
Contacts
Public ContactFengming Luo
West China Hospital, Sichuan University
Outcome results
None listed