tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2022 Aug 8;9(8)
fac406.
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[SUP] 1 [/SUP], Oana Săndulescu[SUP] 2 [/SUP], Liliana-Lucia Preotescu[SUP] 2 [/SUP], Norma E Rivera-Martínez[SUP] 3 [/SUP], Marta Dobryanska[SUP] 4 5 [/SUP], Victoria Birlutiu[SUP] 6 [/SUP], Egidia G Miftode[SUP] 7 [/SUP], Natalia Gaibu[SUP] 8 [/SUP], Olga Caliman-Sturdza[SUP] 9 [/SUP], Simin-Aysel Florescu[SUP] 10 [/SUP], Hye Jin Shi[SUP] 11 [/SUP], Anca Streinu-Cercel[SUP] 2 [/SUP], Adrian Streinu-Cercel[SUP] 2 [/SUP], Sang Joon Lee[SUP] 12 [/SUP], Sung Hyun Kim[SUP] 12 [/SUP], Ilsung Chang[SUP] 12 [/SUP], Yun Ju Bae[SUP] 12 [/SUP], Jee Hye Suh[SUP] 12 [/SUP], Da Rae Chung[SUP] 12 [/SUP], Sun Jung Kim[SUP] 12 [/SUP], Mi Rim Kim[SUP] 12 [/SUP], Seul Gi Lee[SUP] 12 [/SUP], Gahee Park[SUP] 12 [/SUP], Joong Sik Eom[SUP] 11 [/SUP]
Affiliations
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.
. 2022 Aug 8;9(8)
fac406.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[SUP] 1 [/SUP], Oana Săndulescu[SUP] 2 [/SUP], Liliana-Lucia Preotescu[SUP] 2 [/SUP], Norma E Rivera-Martínez[SUP] 3 [/SUP], Marta Dobryanska[SUP] 4 5 [/SUP], Victoria Birlutiu[SUP] 6 [/SUP], Egidia G Miftode[SUP] 7 [/SUP], Natalia Gaibu[SUP] 8 [/SUP], Olga Caliman-Sturdza[SUP] 9 [/SUP], Simin-Aysel Florescu[SUP] 10 [/SUP], Hye Jin Shi[SUP] 11 [/SUP], Anca Streinu-Cercel[SUP] 2 [/SUP], Adrian Streinu-Cercel[SUP] 2 [/SUP], Sang Joon Lee[SUP] 12 [/SUP], Sung Hyun Kim[SUP] 12 [/SUP], Ilsung Chang[SUP] 12 [/SUP], Yun Ju Bae[SUP] 12 [/SUP], Jee Hye Suh[SUP] 12 [/SUP], Da Rae Chung[SUP] 12 [/SUP], Sun Jung Kim[SUP] 12 [/SUP], Mi Rim Kim[SUP] 12 [/SUP], Seul Gi Lee[SUP] 12 [/SUP], Gahee Park[SUP] 12 [/SUP], Joong Sik Eom[SUP] 11 [/SUP]
Affiliations
- PMID: 36043180
- PMCID: PMC9384635
- DOI: 10.1093/ofid/ofac406
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.