Study to Assess the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19)
Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of STI-1558 in adult subjects with mild/moderate COVID-19. One thousand and two hundred adult subjects with mild/moderate COVID-19 (including subjects with high risk factors for progression into severe cases) are planned to be enrolled and randomized in a ratio of 1:1 into the test group or the placebo group (600 in the test group and 600 in the placebo group).
Timeline
- Start
- 2023-02-08
- Primary completion
- 2023-07-26
- Completion
- 2023-07-26
Outcome
Met primary endpoint
paper The median time to symptom recovery was 205 hours in the olgotrelvir group versus 264 hours in the placebo group PMID 38804790 ↗
paper hazard ratio, 1.29; 95% confidence interval [CI], 1.13 to 1.46; P<0.001 PMID 38804790 ↗
Publications
- Jiang R, Han B, Xu W, Zhang X, Peng C, Dang Q, Sun W, Lin L, Lin Y, Fan L, Lv D, Shao L, Chen Y, Qiu Y, Han L, Kong W, Li G, Wang K, Peng J, Lin B, Tong Z, Lu X, Wang L, Gao F, Feng J, Li Y, Ma X, Wang J, Wang S, Shen W, Wang C, Yan K, Lin Z, Jin C, Mao L, Liu J, Kushnareva Y, Kotoi O, Zhu Z, Royal M, Brunswick M, Ji H, Xu X, Lu H. Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19. NEJM Evid. 2024 Jun;3(6):EVIDoa2400026. doi: 10.1056/EVIDoa2400026. Epub 2024 May 28.
- Mao L, Shaabani N, Zhang X, Jin C, Xu W, Argent C, Kushnareva Y, Powers C, Stegman K, Liu J, Xie H, Xu C, Bao Y, Xu L, Zhang Y, Yang H, Qian S, Hu Y, Shao J, Zhang C, Li T, Li Y, Liu N, Lin Z, Wang S, Wang C, Shen W, Lin Y, Shu D, Zhu Z, Kotoi O, Kerwin L, Han Q, Chumakova L, Teijaro J, Royal M, Brunswick M, Allen R, Ji H, Lu H, Xu X. Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. Med. 2024 Jan 12;5(1):42-61.e23. doi: 10.1016/j.medj.2023.12.004. Epub 2024 Jan 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | STI-1558 | Small molecule | 600 mg | Oral |