6/30/23, 12:38 AM VV116 for COVID-19 Pathway Feedback Search Clinical Topics Home Studies VV116 for COVID 19 VV116 for COVID 19 Disease COVID 19 infection Trial question Is VV116 noninferior to nirmatrelvir-ritonavir in adults with mild-to-moderate COVID-19 who were at risk for progression? Study design Multi-center Single blinded RCT Population Characteristics of study participants 50.0% female N = 771 50.0% male 771 patients (387 female, 384 male) Inclusion criteria: symptomatic adults with mild-to-moderate COVID-19 with a high risk of progression Key exclusion criteria: severe or critical COVID-19 or an anticipated need for mechanical ventilation before randomization; an ALT or AST level > 1.5 times the upper limit of the normal range; an eGFR < 60 mL/min Interventions N=384 VV116 (600 mg every 12 hours on day 1 and 300 mg every 12 hours on day 2 through 5) N=387 nirmatrelvir-ritonavir (300 mg of nirmatrelvir plus 100 mg of ritonavir every 12 hours for 5 days) Primary outcome https://web.pathway.md/studies/recXtpD025oG8jTgv 1/2 6/30/23, 12:38 AM VV116 for COVID-19 Pathway Time to sustained clinical recovery through day 28 5.0 days 5 4 3.8 days 2.5 days Difference not exceeding nonferiority margin 1.3 days 0.0 days VV116 Nirmatrelvir-ritonavir Difference not exceeding nonferiority margin in time to sustained clinical recovery through day 28 (4 days vs. 5 days; HR 0.85, 95% CI 0.73 to 0.98) Secondary outcomes No significant difference in time to sustained symptom resolution (7 days vs. 7 days; HR 1.06, 95% CI 0.91 to 1.22) Safety outcomes No significant difference in adverse events. Conclusion In symptomatic adults with mild-to-moderate COVID-19 with a high risk of progression, VV116 was noninferior to nirmatrelvir-ritonavir with respect to time to sustained clinical recovery through day 28. Reference Zhujun Cao, Weiyi Gao, Hong Bao et al. VV116 versus Nirmatrelvir-Ritonavir for Oral Treatment of Covid-19. N Engl J Med. 2023 Feb 2;388(5):406-417. Open reference URL https://web.pathway.md/studies/recXtpD025oG8jTgv 2/2