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. 2022 Aug 8;9(8):ofac406.
doi: 10.1093/ofid/ofac406. eCollection 2022 Aug.

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

Jin Yong Kim  1 , Oana Săndulescu  2 , Liliana-Lucia Preotescu  2 , Norma E Rivera-Martínez  3 , Marta Dobryanska  4   5 , Victoria Birlutiu  6 , Egidia G Miftode  7 , Natalia Gaibu  8 , Olga Caliman-Sturdza  9 , Simin-Aysel Florescu  10 , Hye Jin Shi  11 , Anca Streinu-Cercel  2 , Adrian Streinu-Cercel  2 , Sang Joon Lee  12 , Sung Hyun Kim  12 , Ilsung Chang  12 , Yun Ju Bae  12 , Jee Hye Suh  12 , Da Rae Chung  12 , Sun Jung Kim  12 , Mi Rim Kim  12 , Seul Gi Lee  12 , Gahee Park  12 , Joong Sik Eom  11
Affiliations

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

Jin Yong Kim et al. Open Forum Infect Dis. .

Erratum in

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).

Keywords: COVID-19 treatment; CT-P59; SARS-CoV-2; regdanvimab.

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Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.
Study flowchart. Abbreviation: ITT, intention-to-treat.
Figure 2.
Figure 2.
Kaplan-Meier plot of time to clinical recovery (for ≥48 hours) up to day 14 by treatment group in high-risk patients (ITT high-risk set) (A) and all randomized patients (ITT set) (B). Along with the Kaplan-Meier plot, the clinical recovery ratio between 2 treatment groups and associated 95% CI estimated from the stratified Cox proportional hazard model, and P value from the stratified log-rank test are presented. Abbreviations: CI, confidence interval; ITT, intention-to-treat.
See this image and copyright information in PMC

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