| Autor: |
Jin Yong Kim, Oana Săndulescu, Liliana-Lucia Preotescu, Norma E Rivera-Martínez, Marta Dobryanska, Victoria Birlutiu, Egidia G Miftode, Natalia Gaibu, Olga Caliman-Sturdza, Simin-Aysel Florescu, Hye Jin Shi, Anca Streinu-Cercel, Adrian Streinu-Cercel, Sang Joon Lee, Sung Hyun Kim, Ilsung Chang, Yun Ju Bae, Jee Hye Suh, Da Rae Chung, Sun Jung Kim, Mi Rim Kim, Seul Gi Lee, Gahee Park, Joong Sik Eom |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Open forum infectious diseases. 9(8) |
| ISSN: |
2328-8957 |
| Popis: |
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 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). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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