tetano
Editor, Senior Moderator
NEJM Evid
. 2024 Jun;3(6):EVIDoa2400026.
doi: 10.1056/EVIDoa2400026. Epub 2024 May 28. Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19
Rongmeng Jiang[SUP] 1 [/SUP], Bing Han[SUP] 1 [/SUP], Wanhong Xu[SUP] 2 [/SUP], Xiaoying Zhang[SUP] 2 [/SUP], Chunxian Peng[SUP] 3 [/SUP], Qiang Dang[SUP] 4 [/SUP], Wei Sun[SUP] 5 [/SUP], Ling Lin[SUP] 6 [/SUP], Yuanlong Lin[SUP] 7 [/SUP], Lingyan Fan[SUP] 8 [/SUP], Dongqing Lv[SUP] 9 [/SUP], Lei Shao[SUP] 10 [/SUP], Ying Chen[SUP] 11 [/SUP], Yunqing Qiu[SUP] 12 [/SUP], Limei Han[SUP] 13 [/SUP], Weixiang Kong[SUP] 14 [/SUP], Guangming Li[SUP] 15 [/SUP], Kai Wang[SUP] 16 [/SUP], Jie Peng[SUP] 17 [/SUP], Bingliang Lin[SUP] 18 [/SUP], Zhaowei Tong[SUP] 19 [/SUP], Xiaobo Lu[SUP] 20 [/SUP], Lifeng Wang[SUP] 21 [/SUP], Feng Gao[SUP] 22 [/SUP], Jiemei Feng[SUP] 23 [/SUP], Yongxia Li[SUP] 24 [/SUP], Xiaojun Ma[SUP] 25 [/SUP], Jinxiang Wang[SUP] 26 [/SUP], Shanbo Wang[SUP] 2 [/SUP], Wei Shen[SUP] 2 [/SUP], Chao Wang[SUP] 2 [/SUP], Kuan Yan[SUP] 2 [/SUP], Zhenhao Lin[SUP] 2 [/SUP], Can Jin[SUP] 27 [/SUP], Long Mao[SUP] 27 [/SUP], Jia Liu[SUP] 27 [/SUP], Yulia Kushnareva[SUP] 27 [/SUP], Olivia Kotoi[SUP] 27 [/SUP], Zhenghong Zhu[SUP] 27 [/SUP], Mike Royal[SUP] 28 [/SUP], Mark Brunswick[SUP] 28 [/SUP], Henry Ji[SUP] 28 [/SUP], Xiao Xu[SUP] 27 [/SUP], Hongzhou Lu[SUP] 7 [/SUP]
Affiliations
Background: Olgotrelvir is an oral antiviral with dual mechanisms of action targeting severe acute respiratory syndrome coronavirus 2 main protease (i.e., M[SUP]pro[/SUP]) and human cathepsin L. It has potential to serve as a single-agent treatment of coronavirus disease 2019 (Covid-19).
Methods: We conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of olgotrelvir in 1212 nonhospitalized adult participants with mild to moderate Covid-19, irrespective of risk factors, who were randomly assigned to receive orally either 600 mg of olgotrelvir or placebo twice daily for 5 days. The primary and key secondary end points were time to sustained recovery of a panel of 11 Covid-19-related symptoms and the viral ribonucleic acid (RNA) load. The safety end point was incidence of treatment-emergent adverse events.
Results: The baseline characteristics of 1212 participants were similar in the two groups. In the modified intention-to-treat population (567 patients in the placebo group and 558 in the olgotrelvir group), the median time to symptom recovery was 205 hours in the olgotrelvir group versus 264 hours in the placebo group (hazard ratio, 1.29; 95% confidence interval [CI], 1.13 to 1.46; P<0.001). The least squares mean (95% CI) changes of viral RNA load from baseline were -2.20 (-2.59 to -1.81) log[SUB]10[/SUB] copies/ml in olgotrelvir-treated participants and -1.40 (-1.79 to -1.01) in participants receiving placebo at day 4. Skin rash (3.3%) and nausea (1.5%) were more frequent in the olgotrelvir group than in the placebo group; there were no treatment-related serious adverse events, and no deaths were reported.
Conclusions: Olgotrelvir as a single-agent treatment significantly improved symptom recovery. Adverse effects were not dose limiting. (Funded by Sorrento Therapeutics, a parent company of ACEA Therapeutics; ClinicalTrials.gov number, NCT05716425.).
. 2024 Jun;3(6):EVIDoa2400026.
doi: 10.1056/EVIDoa2400026. Epub 2024 May 28. Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19
Rongmeng Jiang[SUP] 1 [/SUP], Bing Han[SUP] 1 [/SUP], Wanhong Xu[SUP] 2 [/SUP], Xiaoying Zhang[SUP] 2 [/SUP], Chunxian Peng[SUP] 3 [/SUP], Qiang Dang[SUP] 4 [/SUP], Wei Sun[SUP] 5 [/SUP], Ling Lin[SUP] 6 [/SUP], Yuanlong Lin[SUP] 7 [/SUP], Lingyan Fan[SUP] 8 [/SUP], Dongqing Lv[SUP] 9 [/SUP], Lei Shao[SUP] 10 [/SUP], Ying Chen[SUP] 11 [/SUP], Yunqing Qiu[SUP] 12 [/SUP], Limei Han[SUP] 13 [/SUP], Weixiang Kong[SUP] 14 [/SUP], Guangming Li[SUP] 15 [/SUP], Kai Wang[SUP] 16 [/SUP], Jie Peng[SUP] 17 [/SUP], Bingliang Lin[SUP] 18 [/SUP], Zhaowei Tong[SUP] 19 [/SUP], Xiaobo Lu[SUP] 20 [/SUP], Lifeng Wang[SUP] 21 [/SUP], Feng Gao[SUP] 22 [/SUP], Jiemei Feng[SUP] 23 [/SUP], Yongxia Li[SUP] 24 [/SUP], Xiaojun Ma[SUP] 25 [/SUP], Jinxiang Wang[SUP] 26 [/SUP], Shanbo Wang[SUP] 2 [/SUP], Wei Shen[SUP] 2 [/SUP], Chao Wang[SUP] 2 [/SUP], Kuan Yan[SUP] 2 [/SUP], Zhenhao Lin[SUP] 2 [/SUP], Can Jin[SUP] 27 [/SUP], Long Mao[SUP] 27 [/SUP], Jia Liu[SUP] 27 [/SUP], Yulia Kushnareva[SUP] 27 [/SUP], Olivia Kotoi[SUP] 27 [/SUP], Zhenghong Zhu[SUP] 27 [/SUP], Mike Royal[SUP] 28 [/SUP], Mark Brunswick[SUP] 28 [/SUP], Henry Ji[SUP] 28 [/SUP], Xiao Xu[SUP] 27 [/SUP], Hongzhou Lu[SUP] 7 [/SUP]
Affiliations
- PMID: 38804790
- DOI: 10.1056/EVIDoa2400026
Background: Olgotrelvir is an oral antiviral with dual mechanisms of action targeting severe acute respiratory syndrome coronavirus 2 main protease (i.e., M[SUP]pro[/SUP]) and human cathepsin L. It has potential to serve as a single-agent treatment of coronavirus disease 2019 (Covid-19).
Methods: We conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of olgotrelvir in 1212 nonhospitalized adult participants with mild to moderate Covid-19, irrespective of risk factors, who were randomly assigned to receive orally either 600 mg of olgotrelvir or placebo twice daily for 5 days. The primary and key secondary end points were time to sustained recovery of a panel of 11 Covid-19-related symptoms and the viral ribonucleic acid (RNA) load. The safety end point was incidence of treatment-emergent adverse events.
Results: The baseline characteristics of 1212 participants were similar in the two groups. In the modified intention-to-treat population (567 patients in the placebo group and 558 in the olgotrelvir group), the median time to symptom recovery was 205 hours in the olgotrelvir group versus 264 hours in the placebo group (hazard ratio, 1.29; 95% confidence interval [CI], 1.13 to 1.46; P<0.001). The least squares mean (95% CI) changes of viral RNA load from baseline were -2.20 (-2.59 to -1.81) log[SUB]10[/SUB] copies/ml in olgotrelvir-treated participants and -1.40 (-1.79 to -1.01) in participants receiving placebo at day 4. Skin rash (3.3%) and nausea (1.5%) were more frequent in the olgotrelvir group than in the placebo group; there were no treatment-related serious adverse events, and no deaths were reported.
Conclusions: Olgotrelvir as a single-agent treatment significantly improved symptom recovery. Adverse effects were not dose limiting. (Funded by Sorrento Therapeutics, a parent company of ACEA Therapeutics; ClinicalTrials.gov number, NCT05716425.).