tetano
Editor, Senior Moderator
Int J Infect Dis
. 2023 Jan 6;S1201-9712(22)00674-9.
doi: 10.1016/j.ijid.2022.12.035. Online ahead of print.
Regdanvimab for patients with mild-to-moderate COVID-19: a retrospective cohort study and subgroup analysis of patients with the Delta variant
Young Rock Jang[SUP] 1 [/SUP], Yoon Ju Oh[SUP] 2 [/SUP], Jin Yong Kim[SUP] 3 [/SUP]
Affiliations
Abstract
Objectives: To evaluate efficacy and safety of regdanvimab, a neutralizing antibody, in patients with mild-to-moderate severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) including against the Delta variant.
Methods: A single-center, retrospective, observational cohort study in adults with confirmed coronavirus disease 2019 (COVID-19). The primary endpoint was the proportion of patients deteriorating with peripheral oxygen saturation <90% in room air, requiring supplemental oxygen therapy above high flow, or experiencing mortality due to COVID-19 up to Day 28.
Results: 722 patients were eligible; 418 received regdanvimab and 304 received standard of care (SoC) of whom 71.1% (297/418, regdanvimab) and 37.8% (115/304, SoC) were infected with the Delta variant. The proportion of patients with a primary endpoint event was significantly lower with regdanvimab versus SoC (3.1% vs 9.9%; difference: -6.8 [95% confidence interval: -10.9, -2.8]; P=0.0002). A similar trend was observed in the Delta variant subgroup (regdanvimab, 2.7% vs SoC, 7.0%; difference -4.3 [95% CI: -10.8, 0.2]; P=0.0827). Secondary efficacy endpoints supported primary analysis findings in the overall cohort and Delta variant subgroup. No new safety signals were identified.
Conclusions: Regdanvimab demonstrated clinical efficacy in the overall cohort and may provide a clinical benefit for patients with mild-to-moderate COVID-19, infected with the Delta variant.
Keywords: CT-P59; SARS-CoV-2; monoclonal antibody; observational study; regdanvimab.
. 2023 Jan 6;S1201-9712(22)00674-9.
doi: 10.1016/j.ijid.2022.12.035. Online ahead of print.
Regdanvimab for patients with mild-to-moderate COVID-19: a retrospective cohort study and subgroup analysis of patients with the Delta variant
Young Rock Jang[SUP] 1 [/SUP], Yoon Ju Oh[SUP] 2 [/SUP], Jin Yong Kim[SUP] 3 [/SUP]
Affiliations
- PMID: 36623794
- DOI: 10.1016/j.ijid.2022.12.035
Abstract
Objectives: To evaluate efficacy and safety of regdanvimab, a neutralizing antibody, in patients with mild-to-moderate severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) including against the Delta variant.
Methods: A single-center, retrospective, observational cohort study in adults with confirmed coronavirus disease 2019 (COVID-19). The primary endpoint was the proportion of patients deteriorating with peripheral oxygen saturation <90% in room air, requiring supplemental oxygen therapy above high flow, or experiencing mortality due to COVID-19 up to Day 28.
Results: 722 patients were eligible; 418 received regdanvimab and 304 received standard of care (SoC) of whom 71.1% (297/418, regdanvimab) and 37.8% (115/304, SoC) were infected with the Delta variant. The proportion of patients with a primary endpoint event was significantly lower with regdanvimab versus SoC (3.1% vs 9.9%; difference: -6.8 [95% confidence interval: -10.9, -2.8]; P=0.0002). A similar trend was observed in the Delta variant subgroup (regdanvimab, 2.7% vs SoC, 7.0%; difference -4.3 [95% CI: -10.8, 0.2]; P=0.0827). Secondary efficacy endpoints supported primary analysis findings in the overall cohort and Delta variant subgroup. No new safety signals were identified.
Conclusions: Regdanvimab demonstrated clinical efficacy in the overall cohort and may provide a clinical benefit for patients with mild-to-moderate COVID-19, infected with the Delta variant.
Keywords: CT-P59; SARS-CoV-2; monoclonal antibody; observational study; regdanvimab.