Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea
Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and...
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| Autor*in: |
Noh, Hyuna [verfasserIn] Yoon, Suhyeon [verfasserIn] Kim, Sung-Hee [verfasserIn] Kim, Jiseon [verfasserIn] Seo, Jung Seon [verfasserIn] Kim, Jeong Jin [verfasserIn] Park, In Ho [verfasserIn] Oh, Jooyeon [verfasserIn] Bae, Joon-Yong [verfasserIn] Lee, Gee Eun [verfasserIn] Woo, Sun-Je [verfasserIn] Seo, Sun-Min [verfasserIn] Kim, Na-Won [verfasserIn] Lee, Youn Woo [verfasserIn] Jang, Hui Jeong [verfasserIn] Hong, Seung-Min [verfasserIn] An, Se-Hee [verfasserIn] Lyoo, Kwang-Soo [verfasserIn] Yeom, Minjoo [verfasserIn] Lee, Hanbyeul [verfasserIn] Jung, Bud [verfasserIn] Yoon, Sun-Woo [verfasserIn] Kang, Jung-Ah [verfasserIn] Seok, Sang-Hyuk [verfasserIn] Lee, Yu Jin [verfasserIn] Kim, Seo Yeon [verfasserIn] Kim, Young Been [verfasserIn] Hwang, Ji-Yeon [verfasserIn] On, Dain [verfasserIn] Lim, Soo-Yeon [verfasserIn] Kim, Sol Pin [verfasserIn] Jang, Ji Yun [verfasserIn] Lee, Ho [verfasserIn] Kim, Kyoungmi [verfasserIn] Lee, Hyo-Jung [verfasserIn] Kim, Hong Bin [verfasserIn] Kim, Sun Bean [verfasserIn] Park, Jun Won [verfasserIn] Jeong, Dae Gwin [verfasserIn] Song, Daesub [verfasserIn] Choi, Kang-Seuk [verfasserIn] Lee, Ho-Young [verfasserIn] Choi, Yang-Kyu [verfasserIn] Choi, Jung-ah [verfasserIn] Song, Manki [verfasserIn] Park, Man-Seong [verfasserIn] Seo, Jun-Young [verfasserIn] Shin, Jeon-Soo [verfasserIn] Yun, Jun-Won [verfasserIn] Nam, Ki Taek [verfasserIn] Seong, Je Kyung [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Pulmonary pharmacology and therapeutics - Amsterdam [u.a.] : Elsevier, 1997, 80 |
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| Übergeordnetes Werk: |
volume:80 |
| DOI / URN: |
10.1016/j.pupt.2023.102189 |
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| Katalog-ID: |
ELV009861556 |
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| 245 | 1 | 0 | |a Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
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| 520 | |a Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. | ||
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Nonclinical | |
| 650 | 4 | |a hACE2 mouse | |
| 650 | 4 | |a Golden Syrian hamster | |
| 700 | 1 | |a Yoon, Suhyeon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Sung-Hee |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jiseon |e verfasserin |4 aut | |
| 700 | 1 | |a Seo, Jung Seon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jeong Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Park, In Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Oh, Jooyeon |e verfasserin |4 aut | |
| 700 | 1 | |a Bae, Joon-Yong |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Gee Eun |e verfasserin |4 aut | |
| 700 | 1 | |a Woo, Sun-Je |e verfasserin |4 aut | |
| 700 | 1 | |a Seo, Sun-Min |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Na-Won |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Youn Woo |e verfasserin |4 aut | |
| 700 | 1 | |a Jang, Hui Jeong |e verfasserin |4 aut | |
| 700 | 1 | |a Hong, Seung-Min |e verfasserin |4 aut | |
| 700 | 1 | |a An, Se-Hee |e verfasserin |4 aut | |
| 700 | 1 | |a Lyoo, Kwang-Soo |e verfasserin |4 aut | |
| 700 | 1 | |a Yeom, Minjoo |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Hanbyeul |e verfasserin |4 aut | |
| 700 | 1 | |a Jung, Bud |e verfasserin |4 aut | |
| 700 | 1 | |a Yoon, Sun-Woo |e verfasserin |4 aut | |
| 700 | 1 | |a Kang, Jung-Ah |e verfasserin |4 aut | |
| 700 | 1 | |a Seok, Sang-Hyuk |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Yu Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Seo Yeon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Young Been |e verfasserin |4 aut | |
| 700 | 1 | |a Hwang, Ji-Yeon |e verfasserin |4 aut | |
| 700 | 1 | |a On, Dain |e verfasserin |4 aut | |
| 700 | 1 | |a Lim, Soo-Yeon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Sol Pin |e verfasserin |4 aut | |
| 700 | 1 | |a Jang, Ji Yun |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Kyoungmi |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Hyo-Jung |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Hong Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Sun Bean |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Jun Won |e verfasserin |4 aut | |
| 700 | 1 | |a Jeong, Dae Gwin |e verfasserin |4 aut | |
| 700 | 1 | |a Song, Daesub |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Kang-Seuk |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Ho-Young |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Yang-Kyu |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Jung-ah |e verfasserin |4 aut | |
| 700 | 1 | |a Song, Manki |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Man-Seong |e verfasserin |4 aut | |
| 700 | 1 | |a Seo, Jun-Young |e verfasserin |4 aut | |
| 700 | 1 | |a Shin, Jeon-Soo |e verfasserin |4 aut | |
| 700 | 1 | |a Yun, Jun-Won |e verfasserin |4 aut | |
| 700 | 1 | |a Nam, Ki Taek |e verfasserin |4 aut | |
| 700 | 1 | |a Seong, Je Kyung |e verfasserin |0 (orcid)0000-0003-1177-6958 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Pulmonary pharmacology and therapeutics |d Amsterdam [u.a.] : Elsevier, 1997 |g 80 |h Online-Ressource |w (DE-627)268128022 |w (DE-600)1471690-2 |w (DE-576)272349488 |x 1522-9629 |7 nnns |
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| 912 | |a GBV_ILN_2507 | ||
| 912 | |a GBV_ILN_4035 | ||
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10.1016/j.pupt.2023.102189 doi (DE-627)ELV009861556 (ELSEVIER)S1094-5539(23)00001-9 DE-627 ger DE-627 rda eng 610 VZ 15,3 ssgn PHARM DE-84 fid 44.40 bkl 44.84 bkl Noh, Hyuna verfasserin aut Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. SARS-CoV-2 COVID-19 Nonclinical hACE2 mouse Golden Syrian hamster Yoon, Suhyeon verfasserin aut Kim, Sung-Hee verfasserin aut Kim, Jiseon verfasserin aut Seo, Jung Seon verfasserin aut Kim, Jeong Jin verfasserin aut Park, In Ho verfasserin aut Oh, Jooyeon verfasserin aut Bae, Joon-Yong verfasserin aut Lee, Gee Eun verfasserin aut Woo, Sun-Je verfasserin aut Seo, Sun-Min verfasserin aut Kim, Na-Won verfasserin aut Lee, Youn Woo verfasserin aut Jang, Hui Jeong verfasserin aut Hong, Seung-Min verfasserin aut An, Se-Hee verfasserin aut Lyoo, Kwang-Soo verfasserin aut Yeom, Minjoo verfasserin aut Lee, Hanbyeul verfasserin aut Jung, Bud verfasserin aut Yoon, Sun-Woo verfasserin aut Kang, Jung-Ah verfasserin aut Seok, Sang-Hyuk verfasserin aut Lee, Yu Jin verfasserin aut Kim, Seo Yeon verfasserin aut Kim, Young Been verfasserin aut Hwang, Ji-Yeon verfasserin aut On, Dain verfasserin aut Lim, Soo-Yeon verfasserin aut Kim, Sol Pin verfasserin aut Jang, Ji Yun verfasserin aut Lee, Ho verfasserin aut Kim, Kyoungmi verfasserin aut Lee, Hyo-Jung verfasserin aut Kim, Hong Bin verfasserin aut Kim, Sun Bean verfasserin aut Park, Jun Won verfasserin aut Jeong, Dae Gwin verfasserin aut Song, Daesub verfasserin aut Choi, Kang-Seuk verfasserin aut Lee, Ho-Young verfasserin aut Choi, Yang-Kyu verfasserin aut Choi, Jung-ah verfasserin aut Song, Manki verfasserin aut Park, Man-Seong verfasserin aut Seo, Jun-Young verfasserin aut Shin, Jeon-Soo verfasserin aut Yun, Jun-Won verfasserin aut Nam, Ki Taek verfasserin aut Seong, Je Kyung verfasserin (orcid)0000-0003-1177-6958 aut Enthalten in Pulmonary pharmacology and therapeutics Amsterdam [u.a.] : Elsevier, 1997 80 Online-Ressource (DE-627)268128022 (DE-600)1471690-2 (DE-576)272349488 1522-9629 nnns volume:80 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 Pharmazie Pharmazeutika VZ 44.84 Pulmologie VZ AR 80 |
| spelling |
10.1016/j.pupt.2023.102189 doi (DE-627)ELV009861556 (ELSEVIER)S1094-5539(23)00001-9 DE-627 ger DE-627 rda eng 610 VZ 15,3 ssgn PHARM DE-84 fid 44.40 bkl 44.84 bkl Noh, Hyuna verfasserin aut Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. SARS-CoV-2 COVID-19 Nonclinical hACE2 mouse Golden Syrian hamster Yoon, Suhyeon verfasserin aut Kim, Sung-Hee verfasserin aut Kim, Jiseon verfasserin aut Seo, Jung Seon verfasserin aut Kim, Jeong Jin verfasserin aut Park, In Ho verfasserin aut Oh, Jooyeon verfasserin aut Bae, Joon-Yong verfasserin aut Lee, Gee Eun verfasserin aut Woo, Sun-Je verfasserin aut Seo, Sun-Min verfasserin aut Kim, Na-Won verfasserin aut Lee, Youn Woo verfasserin aut Jang, Hui Jeong verfasserin aut Hong, Seung-Min verfasserin aut An, Se-Hee verfasserin aut Lyoo, Kwang-Soo verfasserin aut Yeom, Minjoo verfasserin aut Lee, Hanbyeul verfasserin aut Jung, Bud verfasserin aut Yoon, Sun-Woo verfasserin aut Kang, Jung-Ah verfasserin aut Seok, Sang-Hyuk verfasserin aut Lee, Yu Jin verfasserin aut Kim, Seo Yeon verfasserin aut Kim, Young Been verfasserin aut Hwang, Ji-Yeon verfasserin aut On, Dain verfasserin aut Lim, Soo-Yeon verfasserin aut Kim, Sol Pin verfasserin aut Jang, Ji Yun verfasserin aut Lee, Ho verfasserin aut Kim, Kyoungmi verfasserin aut Lee, Hyo-Jung verfasserin aut Kim, Hong Bin verfasserin aut Kim, Sun Bean verfasserin aut Park, Jun Won verfasserin aut Jeong, Dae Gwin verfasserin aut Song, Daesub verfasserin aut Choi, Kang-Seuk verfasserin aut Lee, Ho-Young verfasserin aut Choi, Yang-Kyu verfasserin aut Choi, Jung-ah verfasserin aut Song, Manki verfasserin aut Park, Man-Seong verfasserin aut Seo, Jun-Young verfasserin aut Shin, Jeon-Soo verfasserin aut Yun, Jun-Won verfasserin aut Nam, Ki Taek verfasserin aut Seong, Je Kyung verfasserin (orcid)0000-0003-1177-6958 aut Enthalten in Pulmonary pharmacology and therapeutics Amsterdam [u.a.] : Elsevier, 1997 80 Online-Ressource (DE-627)268128022 (DE-600)1471690-2 (DE-576)272349488 1522-9629 nnns volume:80 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 Pharmazie Pharmazeutika VZ 44.84 Pulmologie VZ AR 80 |
| allfields_unstemmed |
10.1016/j.pupt.2023.102189 doi (DE-627)ELV009861556 (ELSEVIER)S1094-5539(23)00001-9 DE-627 ger DE-627 rda eng 610 VZ 15,3 ssgn PHARM DE-84 fid 44.40 bkl 44.84 bkl Noh, Hyuna verfasserin aut Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. SARS-CoV-2 COVID-19 Nonclinical hACE2 mouse Golden Syrian hamster Yoon, Suhyeon verfasserin aut Kim, Sung-Hee verfasserin aut Kim, Jiseon verfasserin aut Seo, Jung Seon verfasserin aut Kim, Jeong Jin verfasserin aut Park, In Ho verfasserin aut Oh, Jooyeon verfasserin aut Bae, Joon-Yong verfasserin aut Lee, Gee Eun verfasserin aut Woo, Sun-Je verfasserin aut Seo, Sun-Min verfasserin aut Kim, Na-Won verfasserin aut Lee, Youn Woo verfasserin aut Jang, Hui Jeong verfasserin aut Hong, Seung-Min verfasserin aut An, Se-Hee verfasserin aut Lyoo, Kwang-Soo verfasserin aut Yeom, Minjoo verfasserin aut Lee, Hanbyeul verfasserin aut Jung, Bud verfasserin aut Yoon, Sun-Woo verfasserin aut Kang, Jung-Ah verfasserin aut Seok, Sang-Hyuk verfasserin aut Lee, Yu Jin verfasserin aut Kim, Seo Yeon verfasserin aut Kim, Young Been verfasserin aut Hwang, Ji-Yeon verfasserin aut On, Dain verfasserin aut Lim, Soo-Yeon verfasserin aut Kim, Sol Pin verfasserin aut Jang, Ji Yun verfasserin aut Lee, Ho verfasserin aut Kim, Kyoungmi verfasserin aut Lee, Hyo-Jung verfasserin aut Kim, Hong Bin verfasserin aut Kim, Sun Bean verfasserin aut Park, Jun Won verfasserin aut Jeong, Dae Gwin verfasserin aut Song, Daesub verfasserin aut Choi, Kang-Seuk verfasserin aut Lee, Ho-Young verfasserin aut Choi, Yang-Kyu verfasserin aut Choi, Jung-ah verfasserin aut Song, Manki verfasserin aut Park, Man-Seong verfasserin aut Seo, Jun-Young verfasserin aut Shin, Jeon-Soo verfasserin aut Yun, Jun-Won verfasserin aut Nam, Ki Taek verfasserin aut Seong, Je Kyung verfasserin (orcid)0000-0003-1177-6958 aut Enthalten in Pulmonary pharmacology and therapeutics Amsterdam [u.a.] : Elsevier, 1997 80 Online-Ressource (DE-627)268128022 (DE-600)1471690-2 (DE-576)272349488 1522-9629 nnns volume:80 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 Pharmazie Pharmazeutika VZ 44.84 Pulmologie VZ AR 80 |
| allfieldsGer |
10.1016/j.pupt.2023.102189 doi (DE-627)ELV009861556 (ELSEVIER)S1094-5539(23)00001-9 DE-627 ger DE-627 rda eng 610 VZ 15,3 ssgn PHARM DE-84 fid 44.40 bkl 44.84 bkl Noh, Hyuna verfasserin aut Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. SARS-CoV-2 COVID-19 Nonclinical hACE2 mouse Golden Syrian hamster Yoon, Suhyeon verfasserin aut Kim, Sung-Hee verfasserin aut Kim, Jiseon verfasserin aut Seo, Jung Seon verfasserin aut Kim, Jeong Jin verfasserin aut Park, In Ho verfasserin aut Oh, Jooyeon verfasserin aut Bae, Joon-Yong verfasserin aut Lee, Gee Eun verfasserin aut Woo, Sun-Je verfasserin aut Seo, Sun-Min verfasserin aut Kim, Na-Won verfasserin aut Lee, Youn Woo verfasserin aut Jang, Hui Jeong verfasserin aut Hong, Seung-Min verfasserin aut An, Se-Hee verfasserin aut Lyoo, Kwang-Soo verfasserin aut Yeom, Minjoo verfasserin aut Lee, Hanbyeul verfasserin aut Jung, Bud verfasserin aut Yoon, Sun-Woo verfasserin aut Kang, Jung-Ah verfasserin aut Seok, Sang-Hyuk verfasserin aut Lee, Yu Jin verfasserin aut Kim, Seo Yeon verfasserin aut Kim, Young Been verfasserin aut Hwang, Ji-Yeon verfasserin aut On, Dain verfasserin aut Lim, Soo-Yeon verfasserin aut Kim, Sol Pin verfasserin aut Jang, Ji Yun verfasserin aut Lee, Ho verfasserin aut Kim, Kyoungmi verfasserin aut Lee, Hyo-Jung verfasserin aut Kim, Hong Bin verfasserin aut Kim, Sun Bean verfasserin aut Park, Jun Won verfasserin aut Jeong, Dae Gwin verfasserin aut Song, Daesub verfasserin aut Choi, Kang-Seuk verfasserin aut Lee, Ho-Young verfasserin aut Choi, Yang-Kyu verfasserin aut Choi, Jung-ah verfasserin aut Song, Manki verfasserin aut Park, Man-Seong verfasserin aut Seo, Jun-Young verfasserin aut Shin, Jeon-Soo verfasserin aut Yun, Jun-Won verfasserin aut Nam, Ki Taek verfasserin aut Seong, Je Kyung verfasserin (orcid)0000-0003-1177-6958 aut Enthalten in Pulmonary pharmacology and therapeutics Amsterdam [u.a.] : Elsevier, 1997 80 Online-Ressource (DE-627)268128022 (DE-600)1471690-2 (DE-576)272349488 1522-9629 nnns volume:80 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 Pharmazie Pharmazeutika VZ 44.84 Pulmologie VZ AR 80 |
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10.1016/j.pupt.2023.102189 doi (DE-627)ELV009861556 (ELSEVIER)S1094-5539(23)00001-9 DE-627 ger DE-627 rda eng 610 VZ 15,3 ssgn PHARM DE-84 fid 44.40 bkl 44.84 bkl Noh, Hyuna verfasserin aut Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. SARS-CoV-2 COVID-19 Nonclinical hACE2 mouse Golden Syrian hamster Yoon, Suhyeon verfasserin aut Kim, Sung-Hee verfasserin aut Kim, Jiseon verfasserin aut Seo, Jung Seon verfasserin aut Kim, Jeong Jin verfasserin aut Park, In Ho verfasserin aut Oh, Jooyeon verfasserin aut Bae, Joon-Yong verfasserin aut Lee, Gee Eun verfasserin aut Woo, Sun-Je verfasserin aut Seo, Sun-Min verfasserin aut Kim, Na-Won verfasserin aut Lee, Youn Woo verfasserin aut Jang, Hui Jeong verfasserin aut Hong, Seung-Min verfasserin aut An, Se-Hee verfasserin aut Lyoo, Kwang-Soo verfasserin aut Yeom, Minjoo verfasserin aut Lee, Hanbyeul verfasserin aut Jung, Bud verfasserin aut Yoon, Sun-Woo verfasserin aut Kang, Jung-Ah verfasserin aut Seok, Sang-Hyuk verfasserin aut Lee, Yu Jin verfasserin aut Kim, Seo Yeon verfasserin aut Kim, Young Been verfasserin aut Hwang, Ji-Yeon verfasserin aut On, Dain verfasserin aut Lim, Soo-Yeon verfasserin aut Kim, Sol Pin verfasserin aut Jang, Ji Yun verfasserin aut Lee, Ho verfasserin aut Kim, Kyoungmi verfasserin aut Lee, Hyo-Jung verfasserin aut Kim, Hong Bin verfasserin aut Kim, Sun Bean verfasserin aut Park, Jun Won verfasserin aut Jeong, Dae Gwin verfasserin aut Song, Daesub verfasserin aut Choi, Kang-Seuk verfasserin aut Lee, Ho-Young verfasserin aut Choi, Yang-Kyu verfasserin aut Choi, Jung-ah verfasserin aut Song, Manki verfasserin aut Park, Man-Seong verfasserin aut Seo, Jun-Young verfasserin aut Shin, Jeon-Soo verfasserin aut Yun, Jun-Won verfasserin aut Nam, Ki Taek verfasserin aut Seong, Je Kyung verfasserin (orcid)0000-0003-1177-6958 aut Enthalten in Pulmonary pharmacology and therapeutics Amsterdam [u.a.] : Elsevier, 1997 80 Online-Ressource (DE-627)268128022 (DE-600)1471690-2 (DE-576)272349488 1522-9629 nnns volume:80 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 Pharmazie Pharmazeutika VZ 44.84 Pulmologie VZ AR 80 |
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Enthalten in Pulmonary pharmacology and therapeutics 80 volume:80 |
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Enthalten in Pulmonary pharmacology and therapeutics 80 volume:80 |
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Pharmazie Pharmazeutika Pulmologie |
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SARS-CoV-2 COVID-19 Nonclinical hACE2 mouse Golden Syrian hamster |
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Pulmonary pharmacology and therapeutics |
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Noh, Hyuna @@aut@@ Yoon, Suhyeon @@aut@@ Kim, Sung-Hee @@aut@@ Kim, Jiseon @@aut@@ Seo, Jung Seon @@aut@@ Kim, Jeong Jin @@aut@@ Park, In Ho @@aut@@ Oh, Jooyeon @@aut@@ Bae, Joon-Yong @@aut@@ Lee, Gee Eun @@aut@@ Woo, Sun-Je @@aut@@ Seo, Sun-Min @@aut@@ Kim, Na-Won @@aut@@ Lee, Youn Woo @@aut@@ Jang, Hui Jeong @@aut@@ Hong, Seung-Min @@aut@@ An, Se-Hee @@aut@@ Lyoo, Kwang-Soo @@aut@@ Yeom, Minjoo @@aut@@ Lee, Hanbyeul @@aut@@ Jung, Bud @@aut@@ Yoon, Sun-Woo @@aut@@ Kang, Jung-Ah @@aut@@ Seok, Sang-Hyuk @@aut@@ Lee, Yu Jin @@aut@@ Kim, Seo Yeon @@aut@@ Kim, Young Been @@aut@@ Hwang, Ji-Yeon @@aut@@ On, Dain @@aut@@ Lim, Soo-Yeon @@aut@@ Kim, Sol Pin @@aut@@ Jang, Ji Yun @@aut@@ Lee, Ho @@aut@@ Kim, Kyoungmi @@aut@@ Lee, Hyo-Jung @@aut@@ Kim, Hong Bin @@aut@@ Kim, Sun Bean @@aut@@ Park, Jun Won @@aut@@ Jeong, Dae Gwin @@aut@@ Song, Daesub @@aut@@ Choi, Kang-Seuk @@aut@@ Lee, Ho-Young @@aut@@ Choi, Yang-Kyu @@aut@@ Choi, Jung-ah @@aut@@ Song, Manki @@aut@@ Park, Man-Seong @@aut@@ Seo, Jun-Young @@aut@@ Shin, Jeon-Soo @@aut@@ Yun, Jun-Won @@aut@@ Nam, Ki Taek @@aut@@ Seong, Je Kyung @@aut@@ |
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2023-01-01T00:00:00Z |
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3610 |
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Noh, Hyuna |
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Noh, Hyuna ddc 610 ssgn 15,3 fid PHARM bkl 44.40 bkl 44.84 misc SARS-CoV-2 misc COVID-19 misc Nonclinical misc hACE2 mouse misc Golden Syrian hamster Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
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610 VZ 15,3 ssgn PHARM DE-84 fid 44.40 bkl 44.84 bkl Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea SARS-CoV-2 COVID-19 Nonclinical hACE2 mouse Golden Syrian hamster |
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Noh, Hyuna Yoon, Suhyeon Kim, Sung-Hee Kim, Jiseon Seo, Jung Seon Kim, Jeong Jin Park, In Ho Oh, Jooyeon Bae, Joon-Yong Lee, Gee Eun Woo, Sun-Je Seo, Sun-Min Kim, Na-Won Lee, Youn Woo Jang, Hui Jeong Hong, Seung-Min An, Se-Hee Lyoo, Kwang-Soo Yeom, Minjoo Lee, Hanbyeul Jung, Bud Yoon, Sun-Woo Kang, Jung-Ah Seok, Sang-Hyuk Lee, Yu Jin Kim, Seo Yeon Kim, Young Been Hwang, Ji-Yeon On, Dain Lim, Soo-Yeon Kim, Sol Pin Jang, Ji Yun Lee, Ho Kim, Kyoungmi Lee, Hyo-Jung Kim, Hong Bin Kim, Sun Bean Park, Jun Won Jeong, Dae Gwin Song, Daesub Choi, Kang-Seuk Lee, Ho-Young Choi, Yang-Kyu Choi, Jung-ah Song, Manki Park, Man-Seong Seo, Jun-Young Shin, Jeon-Soo Yun, Jun-Won Nam, Ki Taek Seong, Je Kyung |
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10.1016/j.pupt.2023.102189 |
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establishment of multicenter covid-19 therapeutics preclinical test system in republic of korea |
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Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
| abstract |
Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. |
| abstractGer |
Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. |
| abstract_unstemmed |
Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. |
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| title_short |
Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
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| author2 |
Yoon, Suhyeon Kim, Sung-Hee Kim, Jiseon Seo, Jung Seon Kim, Jeong Jin Park, In Ho Oh, Jooyeon Bae, Joon-Yong Lee, Gee Eun Woo, Sun-Je Seo, Sun-Min Kim, Na-Won Lee, Youn Woo Jang, Hui Jeong Hong, Seung-Min An, Se-Hee Lyoo, Kwang-Soo Yeom, Minjoo Lee, Hanbyeul Jung, Bud Yoon, Sun-Woo Kang, Jung-Ah Seok, Sang-Hyuk Lee, Yu Jin Kim, Seo Yeon Kim, Young Been Hwang, Ji-Yeon On, Dain Lim, Soo-Yeon Kim, Sol Pin Jang, Ji Yun Lee, Ho Kim, Kyoungmi Lee, Hyo-Jung Kim, Hong Bin Kim, Sun Bean Park, Jun Won Jeong, Dae Gwin Song, Daesub Choi, Kang-Seuk Lee, Ho-Young Choi, Yang-Kyu Choi, Jung-ah Song, Manki Park, Man-Seong Seo, Jun-Young Shin, Jeon-Soo Yun, Jun-Won Nam, Ki Taek Seong, Je Kyung |
| author2Str |
Yoon, Suhyeon Kim, Sung-Hee Kim, Jiseon Seo, Jung Seon Kim, Jeong Jin Park, In Ho Oh, Jooyeon Bae, Joon-Yong Lee, Gee Eun Woo, Sun-Je Seo, Sun-Min Kim, Na-Won Lee, Youn Woo Jang, Hui Jeong Hong, Seung-Min An, Se-Hee Lyoo, Kwang-Soo Yeom, Minjoo Lee, Hanbyeul Jung, Bud Yoon, Sun-Woo Kang, Jung-Ah Seok, Sang-Hyuk Lee, Yu Jin Kim, Seo Yeon Kim, Young Been Hwang, Ji-Yeon On, Dain Lim, Soo-Yeon Kim, Sol Pin Jang, Ji Yun Lee, Ho Kim, Kyoungmi Lee, Hyo-Jung Kim, Hong Bin Kim, Sun Bean Park, Jun Won Jeong, Dae Gwin Song, Daesub Choi, Kang-Seuk Lee, Ho-Young Choi, Yang-Kyu Choi, Jung-ah Song, Manki Park, Man-Seong Seo, Jun-Young Shin, Jeon-Soo Yun, Jun-Won Nam, Ki Taek Seong, Je Kyung |
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268128022 |
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c |
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| doi_str |
10.1016/j.pupt.2023.102189 |
| up_date |
2024-07-07T00:36:22.022Z |
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|
| score |
7.4011717 |