The efficacy and safety of inhaled peptide YKYY017 for COVID-19 patients with mild illness: a phase 2 randomized controlled trial

Yeming Wang, Lianhan Shang, Lei Wu, Xia Wang, Banghan Ding, Ke Hu, Yingli He, Guangming Li, Jie Zhai, Junyan Hu, Yingping Tian, Jun Wang, Li Yan, Bin Liu, Gengshen Song (), Yuxian He (), Chen Wang () and Bin Cao ()
Additional contact information
Yeming Wang: China-Japan Friendship Hospital
Lianhan Shang: China-Japan Friendship Hospital
Lei Wu: Hebei Province Hospital of Traditional Chinese Medicine
Xia Wang: Youcare Pharmaceutical Co. Ltd
Banghan Ding: Guangdong Provincial Hospital of Traditional Chinese Medicine
Ke Hu: Renmin Hospital of Wuhan University
Yingli He: The First Affiliated Hospital of Xi’an Jiao Tong University
Guangming Li: The Sixth People’s Hospital of Zhengzhou
Jie Zhai: Beijing Yolax Pharmaceutical Technology Co. Ltd
Junyan Hu: The Third Affiliated Hospital of Guangzhou Medical University
Yingping Tian: The Second Hospital of Hebei Medical University
Jun Wang: The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Li Yan: Hebei General Hospital
Bin Liu: Zhujiang Hospital of Southern Medical University (The Second Clinical Medical College)
Gengshen Song: Youcare Pharmaceutical Co. Ltd
Yuxian He: Chinese Academy of Medical Sciences & Peking Union Medical College
Chen Wang: China-Japan Friendship Hospital
Bin Cao: China-Japan Friendship Hospital

Nature Communications, 2025, vol. 16, issue 1, 1-9

Abstract: Abstract YKYY017 is a SARS-CoV-2 membrane fusion inhibitor. We report efficacy and safety of inhaled YKYY017 for COVID-19 patients with mild to moderate illness from a phase 2 trial (ChiCTR2300075467). 239 patients aged 18-75 years with mostly mild COVID-19 were randomly allocated to receive aerosol inhalation of 10 or 20 mg YKYY017 or placebo once daily. The primary endpoint is the change in SARS-CoV-2 viral load from baseline to Day 4. The mean (±SE) differences in viral load change from baseline were −0.48 ± 0.27 log10 copies/mL (95% CI, −1.01 to 0.06) for the 20 mg group and −0.27 ± 0.27 log10 copies/mL (95% CI, −0.79 to 0.26) for the 10 mg group, compared to the placebo group. Viral load changes at visits other than Day 4 did not differ significantly from placebo in either the 10 or 20 mg YKYY017 groups. The time to sustained symptom recovery was shorter in the 20 mg YKYY017 group (median 117.53, 95%CI 95.33 to 141.45 hours) than in the placebo group (median 143.00, 95%CI 139.17 to 186.87 hours; HR 1.552, 95%CI 1.089 to 2.214, p = 0.0151), whereas the 10 mg YKYY017 group showed a similar but not statistically significant trend compared to placebo (p = 0.0833). The time to sustained symptom alleviation was shorter in both the 20 and 10 mg YKYY017 groups than in the placebo group. The adverse events were mostly mild to moderate. The primary outcome was not met. Following a supplementary phase 1b trial, we are planning another phase 2/3 trial using a twice-daily 20 mg YKYY017 regimen to further assess efficacy and safety.

Date: 2025
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DOI: 10.1038/s41467-025-62214-x

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