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Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19

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机构： [1]Beijing Ditan Hospital Capital Medical University, China. [2]ACEA Pharmaceutical Co., Ltd., Hangzhou, Zhejiang, China. [3]People's Hospital of Quzhou City, Quzhou, Zhejiang, China. [4]Nanyang Central Hospital, Nanyang, Henan, China. [5]People's Hospital of Chongqing Banan District, Chongqing, China. [6]Hainan Third People's Hospital, Sanya, Hainan, China. [7]Shenzhen Third People's Hospital, SUSTech, Shenzhen, China. [8]Ningbo No. 2 Hospital, Ningbo, Zhejiang, China. [9]Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China. [10]Jinan Central Hospital, Jinan, Shandong, China. [11]The Second People's Hospital of Changde, Changde, Hunan, China. [12]The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. [13]The Second Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China. [14]Jining No. 1 People's Hospital, Jining, China. [15]The Sixth People's Hospital of Zhengzhou, Henan, China. [16]The Fourth Affiliated Hospital Zhejiang University School of Medicine, Yiwu, Zhejiang, China. [17]Nangfang Hospital Southern Medical University, Guangzhou, Guangdong, China. [18]The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China. [19]Huzhou Central Hospital, Huzhou, Zhejiang, China. [20]The First Teaching Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China. [21]Xi'an Gaoxin Hospital, Xi'an, Shanxi, China. [22]Linyi People's Hospital, Linyi, Shandong, China. [23]Guigang City People's Hospital, Guiyang, Guangxi, China. [24]The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China. [25]Linfen Central Hospital, Linfeng, Shanxi, China. [26]Beijing Luhe Hospital Affiliated Capital Medical University, Beijing, China. [27]ACEA Therapeutics, Inc., San Diego, CA. [28]Sorrento Therapeutics, Inc., San Diego, CA.

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Olgotrelvir is an oral antiviral with dual mechanisms of action targeting severe acute respiratory syndrome coronavirus 2 main protease (i.e., Mpro) and human cathepsin L. It has potential to serve as a single-agent treatment of coronavirus disease 2019 (Covid-19).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.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) log10 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.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.).

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