A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019
Jin Yong Kim, Oana Săndulescu, Liliana Preoțescu, Norma E. Rivera-Martínez, Marta Dobryanska, Victoria Bîrluțiu, Egidia Miftode, Natalia Gaibu, Olga Adriana Căliman-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
Abstract
Abstract 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).