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c19early.org COVID-19 treatment researchNiclosamideNiclosamide (more..)
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A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19

Kim et al., Nature Communications, doi:10.1038/s41467-025-62423-4, KCT0007307, Aug 2025
https://c19early.org/kim27.html
Recovery time, both.. 29% Improvement Relative Risk Recovery time, low do.. 33% Recovery time, high.. 25% Recovery time, both.. b 4% Recovery time, low.. b 22% Recovery time, high.. b -7% Viral load, both groups 56% Viral load, low dose.. 26% Viral load, high dose.. 66% Niclosamide  Kim et al.  EARLY TREATMENT  DB RCT Is early treatment with niclosamide beneficial for COVID-19? Double-blind RCT 197 patients in South Korea (May - Nov 2022) Faster recovery with niclosamide (p=0.0085) c19early.org Kim et al., Nature Communications, Aug 2025 Favorsniclosamide Favorscontrol 0 0.5 1 1.5 2+
56th treatment shown to reduce risk in August 2025, now with p = 0.0069 from 7 studies.
Lower risk for recovery.
No treatment is 100% effective. Protocols combine treatments.
6,000+ studies for 175 treatments. c19early.org
RCT 300 patients with mild to moderate COVID-19 showing significant symptom improvement with niclosamide nanohybrid (CP-COV03). The high-dose group showed no significant benefit in time to symptom improvement in the primary analysis, which authors attribute to gastrointestinal side effects from excess magnesium oxide content confounding symptom assessment. A post-hoc analysis with three COVID-19 representative symptoms showed significant improvement in both groups.
recovery time, 29.1% lower, relative time 0.71, p = 0.008, treatment 99, control 98, both groups.
recovery time, 33.3% lower, relative time 0.67, p = 0.03, treatment mean 4.0 (±2.54) n=99, control mean 6.0 (±8.84) n=98, low dose, post-hoc COVID-19 symptoms.
recovery time, 25.0% lower, relative time 0.75, p = 0.11, treatment mean 4.5 (±2.5) n=96, control mean 6.0 (±8.84) n=98, high dose, post-hoc COVID-19 symptoms.
recovery time, 4.1% lower, relative time 0.96, p = 0.80, treatment 99, control 98, both groups.
recovery time, 22.2% lower, relative time 0.78, p = 0.28, treatment mean 10.5 (±22.8) n=99, control mean 13.5 (±15.2) n=98, low dose, all symptoms, Table S51.
recovery time, 7.4% higher, relative time 1.07, p = 0.65, treatment mean 14.5 (±15.0) n=96, control mean 13.5 (±15.2) n=98, high dose, all symptoms, Table S51.
viral load, 55.8% lower, relative load 0.44, p = 0.16, treatment 99, control 98, both groups.
viral load, 26.4% lower, relative load 0.74, p = 0.77, treatment mean 62918 (±399629) n=99, control mean 46282 (±413674) n=98, low dose, relative reduction in viral load, mid-recovery, day 2.
viral load, 65.7% lower, relative load 0.34, p = 0.13, treatment mean 135111 (±407691) n=96, control mean 46282 (±413674) n=98, high dose, relative reduction in viral load, mid-recovery, day 2.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kim et al., 1 Aug 2025, Double Blind Randomized Controlled Trial, placebo-controlled, South Korea, peer-reviewed, mean age 42.6, 12 authors, study period 11 May, 2022 - 28 November, 2022, trial KCT0007307. Contact: jhchoy@dankook.ac.kr, seran@yuhs.ac.
A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19
Jung Ho Kim, Sungmin Kym, Shin-Woo Kim, Dae Won Park, Ki Tae Kwon, Jun-Won Seo, Seungjin Yu, Goeun Choi, Jin-Ho Choy, Geun-Woo Jin, Jun Yong Choi
Nature Communications, doi:10.1038/s41467-025-62423-4
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.
Reporting summary Further information on research design is available in the Nature Portfolio Reporting Summary linked to this article. Data availability The datasets generated and analyzed during the current study are not publicly available due to clinical data privacy restrictions and ethical considerations involving patient confidentiality. Access to these clinical data may be granted for non-commercial academic research purposes upon reasonable request and is subjected to approval by the study sponsor, Hyundai Bioscience. Requests should be directed to the corresponding authors, Prof. Jin-Ho Choy (e-mail: jhchoy@dankook.ac.kr) and Prof. Jun Yong Choi (e-mail: seran@yuhs.ac). Requests will be evaluated within two weeks, and the data will be available for one month after approval. The source code used for the data analysis and modeling in this study is publicly available at GitHub: https://github. com/jhchoy1/CPCOV03-CODE.git . All other data supporting the findings of this study, including processed results, are available in the Supplementary Information. Author contributions J.H.K., S.K., S.W.K., D.W.P., K.T.W., J.W.S., were involved in the clinical trial analyses supervised by J.Y.C. along with G.W.J. and J.H.C. The material parts involved synthesis, characterization and analyses were done by S.Y., G.C. and N.S.R. supervised by J.H.C. All authors contributed to the interpretation of the results and have given approval to the final version of the manuscript. ..
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DOI record: { "DOI": "10.1038/s41467-025-62423-4", "ISSN": [ "2041-1723" ], "URL": "http://dx.doi.org/10.1038/s41467-025-62423-4", "abstract": "<jats:title>Abstract</jats:title>\n <jats:p>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.</jats:p>", "alternative-id": [ "62423" ], "article-number": "7084", "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "14 June 2024" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "22 July 2025" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "1 August 2025" }, { "group": { "label": "Competing interests", "name": "EthicsHeading" }, "name": "Ethics", "order": 1, "value": "The authors declare no competing interests." } ], "author": [ { "ORCID": "https://orcid.org/0000-0002-5033-3482", "affiliation": [], "authenticated-orcid": false, "family": "Kim", "given": "Jung Ho", "sequence": "first" }, { "affiliation": [], "family": "Kym", "given": "Sungmin", "sequence": "additional" }, { "affiliation": [], "family": "Kim", "given": "Shin-Woo", "sequence": "additional" }, { "affiliation": [], "family": "Park", "given": "Dae Won", "sequence": "additional" }, { "affiliation": [], "family": "Kwon", "given": "Ki Tae", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-2806-1863", "affiliation": [], "authenticated-orcid": false, "family": "Seo", "given": "Jun-Won", "sequence": "additional" }, { "affiliation": [], "family": "Yu", "given": "Seungjin", "sequence": "additional" }, { "affiliation": [], "family": "Choi", "given": "Goeun", "sequence": "additional" }, { "affiliation": [], "family": "N", "given": "Sanoj Rejinold", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-4149-7100", "affiliation": [], "authenticated-orcid": false, "family": "Choy", "given": "Jin-Ho", "sequence": "additional" }, { "affiliation": [], "family": "Jin", "given": "Geun-woo", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-2775-3315", "affiliation": [], "authenticated-orcid": false, "family": "Choi", "given": "Jun Yong", "sequence": "additional" } ], "container-title": "Nature Communications", "container-title-short": "Nat Commun", "content-domain": { "crossmark-restriction": false, "domain": [ "link.springer.com" ] }, "created": { "date-parts": [ [ 2025, 8, 1 ] ], "date-time": "2025-08-01T18:15:25Z", "timestamp": 1754072125000 }, "deposited": { "date-parts": [ [ 2025, 8, 1 ] ], "date-time": "2025-08-01T18:15:31Z", "timestamp": 1754072131000 }, "indexed": { "date-parts": [ [ 2025, 8, 2 ] ], "date-time": "2025-08-02T00:11:51Z", "timestamp": 1754093511461, "version": "3.41.2" }, "is-referenced-by-count": 0, "issue": "1", "issued": { "date-parts": [ [ 2025, 8, 1 ] ] }, "journal-issue": { "issue": "1", "published-online": { "date-parts": [ [ 2025, 12 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 8, 1 ] ], "date-time": "2025-08-01T00:00:00Z", "timestamp": 1754006400000 } }, { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 8, 1 ] ], "date-time": "2025-08-01T00:00:00Z", "timestamp": 1754006400000 } } ], "link": [ { "URL": "https://www.nature.com/articles/s41467-025-62423-4.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://www.nature.com/articles/s41467-025-62423-4", "content-type": "text/html", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://www.nature.com/articles/s41467-025-62423-4.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "297", "original-title": [], "prefix": "10.1038", "published": { "date-parts": [ [ 2025, 8, 1 ] ] }, "published-online": { "date-parts": [ [ 2025, 8, 1 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "DOI": "10.1016/S2214-109X(20)30264-3", "author": "A Clark", "doi-asserted-by": "crossref", "first-page": "e1003", "journal-title": "Lancet Glob. 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