Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

Phase 3 Completed 822 enrolled Vigonvita Life Sciences

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19.

Timeline

Start: 2022-04-04
Primary completion: 2022-05-13
Completion: 2022-05-31

Outcome

Met primary endpoint

paper The noninferiority of VV116 to nirmatrelvir-ritonavir with respect to the time to sustained clinical recovery was established in the primary analysis PMID 36577095 ↗

release “has reached its pre-specified primary endpoint and secondary efficacy endpoint.” coherus.com ↗

Publications

Cao Z, Gao W, Bao H, Feng H, Mei S, Chen P, Gao Y, Cui Z, Zhang Q, Meng X, Gui H, Wang W, Jiang Y, Song Z, Shi Y, Sun J, Zhang Y, Xie Q, Xu Y, Ning G, Gao Y, Zhao R. VV116 versus Nirmatrelvir-Ritonavir for Oral Treatment of Covid-19. N Engl J Med. 2023 Feb 2;388(5):406-417. doi: 10.1056/NEJMoa2208822. Epub 2022 Dec 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JT001	Small molecule	300 mg	Oral
Subject	Nirmatrelvir	Small molecule	300 mg	Oral
Subject	Ritonavir	Other / unclassified	100 mg	Oral