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 3 days or(and) cough, dyspnea, RR 93% at rest, pulmonary infiltration imaged by chest X-ray or CT scan of the lungs (5)meet at least two of the following high risks for progression to severe or critical COVID-19: 1. >= 65 years old 2. Cardiovascular disease (including hypertension) 3. Chronic lung diseases (for example, chronic obstructive pulmonary disease (COPD), asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension) 4. Diabetes 5. Immunosuppressive disease or immunosuppressive treatment(for example long-term use of corticosteroids or other immunosuppressive drugs lead to decreased immune function) 6. Obesity or overweight (BMI>25 kg/m2) 7. Sickle cell disease 8. Stable cancer 9. Chronic kidney disease (stable) 10. Neurodevelopmental disorders (e.g., cerebral palsy, Down syndrome) or other conditions that lead to medical complexity (e.g., genetic or metabolic syndrome and severe congenital abnormalities) ? Requiring relevant medical support (not related to COVID-19) (such as organotomy, gastrostomy, or positive pressure ventilation) ? Other medical conditions or factors which in the opinion of the investigator, will place the individual participant at high risk of developing severe COVID- 19 (6)received antiviral treatment or prevention(involving an investigational intervention) >= 5 half-lives (PAXLOVID >= 48h, Azifudine >= 72h) (7)volunteered to participate in this study and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: (1)may transfer to non-participating hospitals 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 |
|---|---|
| proportion of subjects whose disease progressed to severe or critical illness; | — |
Secondary
| Measure | Time frame |
|---|---|
| WHO Clinical Progression Scale rating;The time of disease progressed to severe or critical illness;mortality;the ratio and the time of clinical recovery;the ratio of noninvasive mechanical ventilation or HFNC requirement;the ratio of invasive mechanical ventilation requirement;the time of nucleic acid test turned negative;the time of symptoms improvement;duration of hospitalization;the rate of AE ,SAE; | — |
Countries
China
Contacts
Public ContactFengming Luo
West China Hospital, Sichuan University
Outcome results
None listed