Abstract
ObjectiveTo evaluate clinical effectiveness of regdanvimab, a monoclonal antibody agent for treating coronavirus 2019 (COVID-19).MethodsA retrospective cohort study was conducted at two general hospitals during the study period of December 2020 to May 2021. Mild COVID-19 patients with risk factors for disease progression admitted to the hospitals within seven days of symptom onset were enrolled and followed until discharge or referral. Multivariate analyses for disease progression were conducted in the total and propensity score (PS)-matched cohorts.ResultsA total of 778 mild COVID-19 patients were included and classified as the regdanvimab (n = 234) and supportive care (n = 544) groups. Significantly fewer patients required O2 supplementation via nasal prong in the regdanvimab group (8.1%) than in the supportive care group (18.4%, P < 0.001). The decreased risk for O2 support by regdanvimab treatment was noticed in the multivariate analysis of the total cohort (HR 0.570, 95% CI 0.343–0.946, P = 0.030), but it was not statistically significant in the PS-matched cohort (P = 0.057). Progression to severe disease was also significantly lower in the regdanvimab group (2.1%) than in the supportive care group (9.6%, P < 0.001). The significantly reduced risk for progression to severe disease by regdanvimab treatment was observed in the analysis of both the total cohort (HR 0.262, 95% CI 0.103–0.667, P = 0.005) and PS-matched cohort (HR 0.176, 95% CI 0.060–0.516, P = 0.002). Potential risk factors for progression were investigated in the supportive care group and SpO2 < 97% and CRP elevation >1.5 mg/dL were common risk factors for O2 support and progression to severe disease. Among the patients with any of these factors, regdanvimab treatment was associated with decreased risk for progression to severe disease with slightly lower HR (HR 0.202, 95% CI 0.062–0.657, P = 0.008) than that of the total cohort.ConclusionRegdanvimab treatment was associated with a decreased risk of progression to severe disease.
Highlights
The coronavirus disease 2019 (COVID-19) pandemic is ongoing and has caused more than four million deaths as of October 2021 [1]
The decreased risk for O2 support by regdanvimab treatment was noticed in the multivariate analysis of the total cohort (HR 0.570, 95% CI 0.343–0.946, P = 0.030), but it was not statistically significant in the PSmatched cohort (P = 0.057)
The significantly reduced risk for progression to severe disease by regdanvimab treatment was observed in the analysis of both the total cohort (HR 0.262, 95% CI 0.103–0.667, P = 0.005) and propensity score (PS)-matched cohort (HR 0.176, 95% CI 0.060–0.516, P = 0.002)
Summary
The coronavirus disease 2019 (COVID-19) pandemic is ongoing and has caused more than four million deaths as of October 2021 [1]. In the phase III trial, casirivimab/imdevimab decreased viral load faster than placebo, and COVID-19-related hospitalization or death from any causes were significantly reduced both in 2400mg and 1200mg arm (relative risk reduction of 71.3% and 70.4%, respectively) [7]. Regdanvimab (CT-P59, Celltrion Inc, Incheon, Republic of Korea), a mAb agent against SARS-CoV-2, was approved by the Korea Ministry of Food and Drug Safety for the treatment of mild COVID-19 patients with risk factors for progression on February 5, 2021 based on the results of in-vitro study and the interim data of a phase II/III clinical trial [6, 11], and was reviewed by European Medicines Agency on March 2, 2021 for the support of national decisions on early use [12]. To evaluate the clinical response to regdanvimab in the real world, we conducted a retrospective cohort study evaluating the pre- and post-periods of regdanvimab treatment
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