A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019.

Autor: Kim JY; Department of Internal Medicine, Division of Infectious Diseases, Incheon Medical Center, Incheon, Republic of Korea., Săndulescu O; National Institute for Infectious Diseases 'Prof Dr Matei Balş,' Carol Davila University of Medicine and Pharmacy, Bucharest, Romania., Preotescu LL; National Institute for Infectious Diseases 'Prof Dr Matei Balş,' Carol Davila University of Medicine and Pharmacy, Bucharest, Romania., Rivera-Martínez NE; Oaxaca Site Management Organization, Oaxaca, Mexico., Dobryanska M; City Clinical Hospital 12, Kyiv, Ukraine.; ARENSIA Exploratory Medicine, Kyiv, Ukraine., Birlutiu V; Faculty of Medicine, Lucian Blaga University of Sibiu, Emergency Clinical County Hospital, Sibiu, Romania., Miftode EG; Clinical Hospital of Infectious Diseases 'Sfanta Parascheva,' University of Medicine and Pharmacy 'Gr. T. Popa,' Iasi, Romania., Gaibu N; Institutul Oncologic din Republica Moldova Republican Clinical Hospital 'T. Moşneaga,' ARENSIA Exploratory Medicine, Chisinau, Moldova., Caliman-Sturdza O; Stefan cel Mare University, Suceava, Romania., Florescu SA; Dr Victor Babes Clinical Hospital for Tropical and Infectious Diseases, Bucharest, Romania., Shi HJ; Department of Internal Medicine, Division of Infectious Diseases, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea., Streinu-Cercel A; National Institute for Infectious Diseases 'Prof Dr Matei Balş,' Carol Davila University of Medicine and Pharmacy, Bucharest, Romania., Streinu-Cercel A; National Institute for Infectious Diseases 'Prof Dr Matei Balş,' Carol Davila University of Medicine and Pharmacy, Bucharest, Romania., Lee SJ; Celltrion, Inc, Incheon, Republic of Korea., Kim SH; Celltrion, Inc, Incheon, Republic of Korea., Chang I; Celltrion, Inc, Incheon, Republic of Korea., Bae YJ; Celltrion, Inc, Incheon, Republic of Korea., Suh JH; Celltrion, Inc, Incheon, Republic of Korea., Chung DR; Celltrion, Inc, Incheon, Republic of Korea., Kim SJ; Celltrion, Inc, Incheon, Republic of Korea., Kim MR; Celltrion, Inc, Incheon, Republic of Korea., Lee SG; Celltrion, Inc, Incheon, Republic of Korea., Park G; Celltrion, Inc, Incheon, Republic of Korea., Eom JS; Department of Internal Medicine, Division of Infectious Diseases, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2022 Aug 08; Vol. 9 (8), pp. ofac406. Date of Electronic Publication: 2022 Aug 08 (Print Publication: 2022).
DOI: 10.1093/ofid/ofac406
Abstrakt: Background: We evaluated clinical effectiveness of regdanvimab (CT-P59), a severe acute respiratory syndrome coronavirus 2 neutralizing monoclonal antibody, in reducing disease progression and clinical recovery time in patients with mild-to-moderate coronavirus disease 2019 (COVID-19), primarily Alpha variant.
Methods: This was phase 3 of a phase 2/3 parallel-group, double-blind, randomized clinical trial. Outpatients with mild-to-moderate COVID-19 were randomized to single-dose regdanvimab 40 mg/kg (n = 656) or placebo (n = 659), alongside standard of care. The primary endpoint was COVID-19 disease progression up to day 28 among "high-risk" patients. Key secondary endpoints were disease progression (all randomized patients) and time to recovery (high-risk and all randomized patients).
Results: Of 1315 randomized patients, 880 were high risk; the majority were infected with Alpha variant. The proportion with disease progression was lower (14/446, 3.1% [95% confidence interval {CI}, 1.9%-5.2%] vs 48/434, 11.1% [95% CI, 8.4%-14.4%]; P  < .001) and time to recovery was shorter (median, 9.27 days [95% CI, 8.27-11.05 days] vs not reached [95% CI, 12.35-not calculable]; P  < .001) with regdanvimab than placebo. Consistent improvements were seen in all randomized and non-high-risk patients who received regdanvimab. Viral load reductions were more rapid with regdanvimab. Infusion-related reactions occurred in 11 patients (4/652 [0.6%] regdanvimab, 7/650 [1.1%] placebo). Treatment-emergent serious adverse events were reported in 5 of (4/652 [0.6%] regdanvimab and 1/650 [0.2%] placebo).
Conclusions: Regdanvimab was an effective treatment for patients with mild-to-moderate COVID-19, significantly reducing disease progression and clinical recovery time without notable safety concerns prior to the emergence of the Omicron variant.
Clinical Trials Registration: NCT04602000; 2020-003369-20 (EudraCT).
Competing Interests: Potential conflicts of interest. J. Y. K. has been an investigator in COVID-19 clinical trials by Daewoong Pharmaceuticals, Enzychem Lifesciences, and GC Pharma, outside the scope of the submitted work, and by Celltrion, Inc, within the scope of the submitted work. O. S., An. S.-C., and Ad. S.-C. have been investigators in COVID-19 clinical trials by Algernon Pharmaceuticals, Atea Pharmaceuticals, Diffusion Pharmaceuticals, and Regeneron Pharmaceuticals, outside the scope of the submitted work, and by Celltrion, Inc, within the scope of the submitted work. L.-L. P., N. E. R.-M., M. D., V. B., E. G. M., N. G., O. C.-S., S.-A. F., and H. J. S. have been investigators in COVID-19 clinical trials by Celltrion, Inc, within the scope of the submitted work. S. J. L. and S. H. K. are employees of, and hold shares in, Celltrion, Inc. I. C., Y. J. B., J. H. S., D. R. C., S. J. K., M. R. K., S. G. L., and G. P. are employees of Celltrion, Inc. J. S. E. has been an investigator in COVID-19 clinical trials by Enzychem Lifesciences, Bukwang Pharm. Co., Ltd, and SK Chemicals outside the scope of the submitted work, and by Celltrion, Inc, within the scope of the submitted work.
(© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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