The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study

Abstract

Introduction: Coronavirus disease 2019 (COVID-19) still has a high mortality rate when it is severe. Regdanvimab (CT-P59), a neutralizing monoclonal antibody that has been proven effective against mild to moderate COVID-19, may be effective against severe COVID-19. This study was conducted to determine the effectiveness of the combined use of remdesivir and regdanvimab in patients with severe COVID-19. Methods: From March to early May 2021, 124 patients with severe COVID-19 were admitted to Ulsan University Hospital (Ulsan, Korea) and received oxygen therapy and remdesivir. Among them, 25 were also administered regdanvimab before remdesivir. We retrospectively compared the clinical outcomes between the remdesivir alone group [n = 99 (79.8%)] and the regdanvimab/remdesivir group [n = 25 (20.2%)]. Results: The oxygen-free days on day 28 (primary outcome) were significantly higher in the regdanvimab/remdesivir group [mean ± SD: 19.36 ± 7.87 vs. 22.72 ± 3.66, p = 0.003]. The oxygen-free days was also independently associated with use of regdanvimab in the multivariate analysis, after adjusting for initial pulse oximetric saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio (severity index). Further, in the regdanvimab/remdesivir group, the lowest SpO2/FiO2 ratio during treatment was significantly higher (mean ± SD: 237.05 ± 89.68 vs. 295.63 ± 72.74, p = 0.003), and the Kaplan-Meier estimates of oxygen supplementation days in surviving patients (on day 28) were significantly shorter [mean ± SD: 8.24 ± 7.43 vs. 5.28 ± 3.66, p = 0.024]. Conclusions: In patients with severe COVID-19, clinical outcomes can be improved by administering regdanvimab, in addition to remdesivir.

Efficacy and safety of regdanvimab in patients with mild to moderate COVID‐19: A rapid review and meta‐analysis

“…Out of a total of 138 studies after removing duplicates, 12 full-text studies were assessed for eligibility. Four studies were excluded due to irrelevant data, 22,27 combination therapy 28 or review article. 29 Finally, 8 studies 16,20,21,[30][31][32][33][34] including 2 RCTs 16,32 and 6 observational studies 20,21,30,31,33,34 with 4793 patients were considered in the meta-analysis.…”

Effectiveness of regdanvimab on mortality in COVID-19 infected patients on hemodialysis

“…In previous clinical trials, regdanvimab was found to be effective in reducing the progression rates to severe COVID-19 among patients with mild-to-moderate COVID-19 and shortening the clinical recovery time in patients treated with regdanvimab [ 19 , 20 ]. Recent retrospective studies showed that regdanvimab treatment prevented progression to severe disease; additionally, the use of regdanvimab in addition to remdesivir had a significantly favorable impact on the clinical outcomes of severe COVID-19 [ 21 , 22 ]. Although patients with chronic kidney disease, including those on dialysis, can undergo regdanvimab treatment, there is a lack of data on the clinical effectiveness and safety of these patients who are at high risk of suffering excess morbidity and mortality.…”

COVID-19: Current Status and Future Prospects

“…Our knowledge has expanded on the pathogenesis and treatment of COVID-19 and experience gained within different countries, and this is reflected in the enormous number of scientific papers generated, including those in this Special Issue. There have been 24 papers published upon peer review acceptance in this Special Issue, including 17 research papers [ 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 ], 2 review papers [ 20 , 21 ], 1 opinion piece [ 22 ], 1 commentary [ 23 ], and 3 systematic reviews [ 24 , 25 , 26 ]. Each paper in this Special Issue contributes to our understanding of COVID-19.…”

“…The twelfth study was conducted to determine the effectiveness of the combined use of remdesivir and regdanvimab in patients with severe COVID-19. In patients with severe COVID-19, clinical outcomes can be improved by administering regdanvimab in addition to remdesivir [ 14 ]. In the thirteenth study, the authors compared excess all-cause mortality and COVID-19 mortality in 25 Peruvian regions to determine whether most excess deaths in 2020 were attributable to COVID-19.…”