| Title: |
A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019 |
| Authors: |
Kim, Jin Yong; Săndulescu, Oana; Preotescu, Liliana-Lucia; Rivera-Martínez, Norma E; Dobryanska, Marta; Birlutiu, Victoria; Miftode, Egidia G; Gaibu, Natalia; Caliman-Sturdza, Olga; Florescu, Simin-Aysel; Shi, Hye Jin; Streinu-Cercel, Anca; Streinu-Cercel, Adrian; Lee, Sang Joon; Kim, Sung Hyun; Chang, Ilsung; Bae, Yun Ju; Suh, Jee Hye; Chung, Da Rae; Kim, Sun Jung; Kim, Mi Rim; Lee, Seul Gi; Park, Gahee; Eom, Joong Sik |
| Contributors: |
Celltrion, Inc; Korea Health Technology R&D Project; the Korea Health Industry Development Institute; Ministry of Health and Welfare, Republic of Korea |
| Source: |
Open Forum Infectious Diseases ; volume 9, issue 8 ; ISSN 2328-8957 |
| Publisher Information: |
Oxford University Press (OUP) |
| Publication Year: |
2022 |
| Description: |
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). |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1093/ofid/ofac406 |
| DOI: |
10.1093/ofid/ofac406/45287239/ofac406.pdf |
| Availability: |
https://doi.org/10.1093/ofid/ofac406; https://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofac406/45287239/ofac406.pdf; https://academic.oup.com/ofid/article-pdf/9/8/ofac406/50030344/ofac406.pdf |
| Rights: |
https://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Accession Number: |
edsbas.C577053F |
| Database: |
BASE |