The Efficacy of VV116 in trEatment of Non-early moderaTe Covid-19: a multicenter, randomized, double-blind, placebo-controlled clinical trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: VV116 group :VV116+standard treatment;control group : palcebo+standard treatment ; CONDITION: COVID‐19 PRIMARY OUTCOME: proportion of subjects whose disease progressed to severe or critical illness; SECONDARY OUTCOME: 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; 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 <=30 within 48 hours prior to the inclusion (4)hyperpyrexia >3 days or(and) cough, dyspnea, RR <30/min, SpO2 > 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 o
Epistemonikos ID: 8db6a4154e80aedfa45fb58645b14b2f2c3e89e9
First added on: Jan 16, 2023