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0 0.5 1 1.5 2+ Severe case 67% Improvement Relative Risk Recovery time 15% Recovery 14% Viral load 24% Deuremidevir  Fan et al.  EARLY TREATMENT  DB RCT Is early treatment with deuremidevir beneficial for COVID-19? Double-blind RCT 1,296 patients in China (October 2022 - January 2023) Faster recovery (p=0.012) and improved viral clearance (p=0.0064) Fan et al., The Lancet Infectious Dise.., Nov 2023 Favors deuremidevir Favors control

Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study

Fan et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(23)00577-7, NCT05582629
Nov 2023  
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RCT 1,369 patients with mild-to-moderate COVID-19 showing significantly faster time to sustained clinical symptom resolution (median 10.9 days vs 12.9 days) with VV116 compared to placebo. VV116 was given as 0.6g BID day 1 followed by 0.3g BID on days 2-5.
risk of severe case, 66.6% lower, RR 0.33, p = 1.00, treatment 0 of 646 (0.0%), control 1 of 650 (0.2%), NNT 650, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
recovery time, 14.5% lower, HR 0.85, p = 0.01, treatment 646, control 650, inverted to make HR<1 favor treatment, time to sustained clinical symptom resolution.
risk of no recovery, 14.2% lower, RR 0.86, p = 0.14, treatment 133 of 646 (20.6%), control 156 of 650 (24.0%), NNT 29.
viral load, 23.8% lower, relative load 0.76, p = 0.006, treatment mean 3.11 (±1.64) n=99, control mean 2.37 (±2.16) n=107, relative change in viral load, day 5.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Fan et al., 30 Nov 2023, Double Blind Randomized Controlled Trial, placebo-controlled, China, peer-reviewed, 39 authors, study period 21 October, 2022 - 18 January, 2023, trial NCT05582629 (history). Contact:
This PaperDeuremidevirAll
Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study
Xiaohong Fan, Xiahong Dai, Yun Ling, Lihua Wu, Lingling Tang, Chunxian Peng, Chaolin Huang, Hongyan Liu, Hongzhou Lu, Xinghua Shen, Wei Zhang, Furong Wang, Guangming Li, Ming Li, Yanming Huang, Hongying Zhang, Minghui Li, Fei Ren, Yuanyuan Li, Chenfan Liu, Zhiguo Zhou, Wei Sun, Yongxiang Yi, Daming Zhou, Hainv Gao, Qi Pan, Hongde Liu, Jiang Zhao, Zhen Ding, Yingmin Ma, Wei Li, Quanhong Wang, Xicheng Wang, Yichun Bai, Xiangao Jiang, MM Juan Ma, PhD Bingying Xie, Kui Zhang, Dr Lanjuan Li
The Lancet Infectious Diseases, doi:10.1016/s1473-3099(23)00577-7
Background Spread of SARS-CoV-2 led to a global pandemic, and there remains unmet medical needs in the treatment of Omicron infections. VV116, an oral antiviral agent that has potent activity against SARS-CoV-2, was compared with a placebo in this phase 3 study to investigate its efficacy and safety in patients with mild-to-moderate COVID-19. Methods This multicentre, double-blind, phase 3, randomised controlled study enrolled adults in hospitals for infectious diseases and tertiary general hospitals in China. Eligible patients were randomly assigned in a 1:1 ratio using permuted block randomisation to receive oral VV116 (0•6 g every 12 h on day 1 and 0•3 g every 12 h on days 2-5) or oral placebo (on the same schedule as VV116) for 5 days. Randomisation stratification factors included SARS-CoV-2 vaccination status and the presence of high-risk factors for progression to severe COVID-19. Inclusion criteria were a positive SARS-CoV-2 test, an initial onset of COVID-19 symptoms 3 days or less before the first study dose, and a score of 2 or more for any target COVID-19-related symptoms in the 24 h before the first dose. Patients who had severe or critical COVID-19 or who had taken any antiviral drugs were excluded from the study. The primary endpoint was the time to clinical symptom resolution for 2 consecutive days. Efficacy analyses were performed on a modified intention-to-treat population, comprising all patients who received at least one dose of VV116 or placebo, tested positive for SARS-CoV-2 nucleic acid, and did not test positive for influenza virus before the first dose. Safety analyses were done on all participants who received at least one dose of VV116 or placebo. This study was registered with, NCT05582629, and has been completed. Findings A total of 1369 patients were randomly assigned to treatment groups and 1347 received either VV116 (n=674) or placebo (n=673). At the interim analysis, VV116 was superior to placebo in reducing the time to sustained clinical symptom resolution among 1229 patients (hazard ratio [HR] 1•21, 95% CI 1•04-1•40; p=0•0023). At the final analysis, a substantial reduction in time to sustained clinical symptom resolution was observed for VV116 compared with placebo among 1296 patients (HR 1•17, 95% CI 1•04-1•33; p=0•0009), consistent with the interim analysis. The incidence of adverse events was similar between groups (242 [35•9%] of 674 patients vs 283 [42•1%] of 673 patients). Interpretation Among patients with mild-to-moderate COVID-19, VV116 significantly reduced the time to sustained clinical symptom resolution compared with placebo, with no observed safety concerns.
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