A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19
Abstract Effective and reliable treatments for SARS-CoV-2 infections are a key part of global COVID-19 management. Based on vitro studies, niclosamide has been considered as a potential drug candidate for SARS-CoV-2, but its clinical development has been limited due to poor solubility and bioavailab...
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Nature Portfolio
2025-08-01
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| Series: | Nature Communications |
| Online Access: | https://doi.org/10.1038/s41467-025-62423-4 |
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| author | Jung Ho Kim Sungmin Kym Shin-Woo Kim Dae Won Park Ki Tae Kwon Jun-Won Seo Seungjin Yu Goeun Choi Sanoj Rejinold N Jin-Ho Choy Geun-woo Jin Jun Yong Choi |
| author_facet | Jung Ho Kim Sungmin Kym Shin-Woo Kim Dae Won Park Ki Tae Kwon Jun-Won Seo Seungjin Yu Goeun Choi Sanoj Rejinold N Jin-Ho Choy Geun-woo Jin Jun Yong Choi |
| author_sort | Jung Ho Kim |
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| description | Abstract Effective and reliable treatments for SARS-CoV-2 infections are a key part of global COVID-19 management. Based on vitro studies, niclosamide has been considered as a potential drug candidate for SARS-CoV-2, but its clinical development has been limited due to poor solubility and bioavailability. Here we report results from a randomized, double-blind, placebo-controlled clinical trial involving 300 patients (Clinical Trial Registration Number: KCT0007307) that assessed the efficacy and safety of the niclosamide nanohybrid CP-COV03 at two different doses. Oral CP-COV03 was well tolerated, with no serious adverse events reported in any treatment group. The primary endpoints demonstrated that CP-COV03 significantly alleviated all 12 FDA-recommended COVID-19 symptoms, with symptom improvement sustained for more than 48 h. Additionally, CP-COV03 reduced SARS-CoV-2 viral load by 56.7% within 16 h of the initial dose compared to baseline. Secondary endpoints, including time to sustained symptom resolution, time to return to usual health, and reduction in hospitalization risk, also showed favorable results in the CP-COV03 group compared to placebo. These findings indicate that CP-COV03 is a safe and effective therapeutic option for the treatment of mild to moderate COVID-19 and represents a promising advancement in the repurposing of niclosamide through nanohybrid engineering. |
| format | Article |
| id | doaj-art-6578e652a2464a1da826fd976615ee5d |
| institution | Kabale University |
| issn | 2041-1723 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Nature Communications |
| spelling | doaj-art-6578e652a2464a1da826fd976615ee5d2025-08-20T03:46:15ZengNature PortfolioNature Communications2041-17232025-08-011611910.1038/s41467-025-62423-4A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19Jung Ho Kim0Sungmin Kym1Shin-Woo Kim2Dae Won Park3Ki Tae Kwon4Jun-Won Seo5Seungjin Yu6Goeun Choi7Sanoj Rejinold N8Jin-Ho Choy9Geun-woo Jin10Jun Yong Choi11Department of Internal Medicine, Yonsei University College of MedicineDivision of Infectious Diseases, Department of Internal Medicine, Chungnam National University Sejong Hospital, Chungnam National University School of MedicineDepartment of Internal Medicine, School of Medicine, Kyungpook National UniversityDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-siDivision of Infectious Diseases, Department of Internal Medicine, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National UniversityDivision of Infectious Disease, Department of Internal Medicine, College of Medicine, Chosun University, 365, Pilmun-daero, Dong-guDepartment of Nanobiomedical Science, Dankook UniversityDepartment of Nanobiomedical Science, Dankook UniversityIntelligent Nanohybrid Materials Laboratory (INML), Department of Chemistry, College of Science and Technology, Dankook UniversityIntelligent Nanohybrid Materials Laboratory (INML), Department of Chemistry, College of Science and Technology, Dankook UniversityR&D Center, Hyundai Bioscience Co., LTDDepartment of Internal Medicine, Yonsei University College of MedicineAbstract Effective and reliable treatments for SARS-CoV-2 infections are a key part of global COVID-19 management. Based on vitro studies, niclosamide has been considered as a potential drug candidate for SARS-CoV-2, but its clinical development has been limited due to poor solubility and bioavailability. Here we report results from a randomized, double-blind, placebo-controlled clinical trial involving 300 patients (Clinical Trial Registration Number: KCT0007307) that assessed the efficacy and safety of the niclosamide nanohybrid CP-COV03 at two different doses. Oral CP-COV03 was well tolerated, with no serious adverse events reported in any treatment group. The primary endpoints demonstrated that CP-COV03 significantly alleviated all 12 FDA-recommended COVID-19 symptoms, with symptom improvement sustained for more than 48 h. Additionally, CP-COV03 reduced SARS-CoV-2 viral load by 56.7% within 16 h of the initial dose compared to baseline. Secondary endpoints, including time to sustained symptom resolution, time to return to usual health, and reduction in hospitalization risk, also showed favorable results in the CP-COV03 group compared to placebo. These findings indicate that CP-COV03 is a safe and effective therapeutic option for the treatment of mild to moderate COVID-19 and represents a promising advancement in the repurposing of niclosamide through nanohybrid engineering.https://doi.org/10.1038/s41467-025-62423-4 |
| spellingShingle | Jung Ho Kim Sungmin Kym Shin-Woo Kim Dae Won Park Ki Tae Kwon Jun-Won Seo Seungjin Yu Goeun Choi Sanoj Rejinold N Jin-Ho Choy Geun-woo Jin Jun Yong Choi A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19 Nature Communications |
| title | A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19 |
| title_full | A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19 |
| title_fullStr | A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19 |
| title_full_unstemmed | A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19 |
| title_short | A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19 |
| title_sort | randomized double blind placebo controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate covid 19 |
| url | https://doi.org/10.1038/s41467-025-62423-4 |
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