Lancet Infect Dis

Investigational COVID-19 oral antiviral shows promise in phase 3 trial

December 1, 2023

Among patients with mild-to-moderate COVID-19, VV116 (a deuterated remdesivir hydrobromide also known as mindeudesivir) significantly reduced time to sustained clinical symptom resolution compared with placebo, with no observed safety concerns.

• This multicenter, double-blind, phase 3, randomized controlled trial enrolled adult patients with mild to moderate COVID-19 in hospitals for infectious diseases and tertiary general hospitals in China.
• 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 hours before the first dose.
• Patients who had severe or critical COVID-19 or who had taken any antiviral drugs were excluded from the study.
• BA.5.2.48 and BF.7.14 were the leading Omicron subvariants in the enrolled population.
• Eligible patients were randomly assigned in a 1:1 ratio to receive oral VV116 (0.6 g q12h on day 1 and 0.3 g q12h on days 2-5) or oral placebo (on the same schedule as VV116) for 5 days.
• Primary endpoint was the time to clinical symptom resolution for 2 consecutive days.
• 1,748 patients were screened for eligibility, of whom 1,369 were enrolled and randomly assigned to study groups. 1,347 participants completed follow-up: 674 in the VV116 group and 673 in the placebo group. 
• At the interim analysis, VV116 was superior to placebo in reducing the time to sustained clinical symptom resolution among 1,229 patients (hazard ratio [HR], 1.21, 95% confidence interval [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 1,296 patients (HR, 1.17; 95% CI, 1.04-1.33; p=0.0009), consistent with the interim analysis.
• Incidence of adverse events was similar between groups (242 [35.9%] of 674 patients vs. 283 [42.1%] of 673 patients).

Source:

Fan Xiaohong, et al. (2023, November 22). Lancet Infect Dis. Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study. https://pubmed.ncbi.nlm.nih.gov/38006892/