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All Studies   Meta Analysis    Recent:   

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

Chae et al., Tropical Medicine and Infectious Disease, doi:10.3390/tropicalmed7030051
Mar 2022  
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Mortality 71% Improvement Relative Risk Ventilation 64% Hospitalization time 9% Regdanvimab for COVID-19  Chae et al.  EARLY TREATMENT Is early treatment with regdanvimab beneficial for COVID-19? Retrospective 124 patients in South Korea (March - May 2021) Lower ventilation with regdanvimab (not stat. sig., p=0.46) c19early.org Chae et al., Tropical Medicine and Inf.., Mar 2022 Favorsregdanvimab Favorscontrol 0 0.5 1 1.5 2+
36th treatment shown to reduce risk in March 2022
 
*, now with p < 0.00000000001 from 11 studies, recognized in 27 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
Retrospective 124 hospitalized severe COVID-19 patients receiving oxygen and remdesivir treatment in South Korea. A subgroup of 25 patients also received the monoclonal antibody regdanvimab prior to remdesivir. The regdanvimab subgroup had significantly more oxygen-free days (primary outcome), higher oxygen saturation, less advanced respiratory support, and shorter oxygen supplementation duration compared to the remdesivir alone group.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2, BA.4, BA.51, ХВВ.1.9.1, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.12.
Although the 71% lower mortality is not statistically significant, it is consistent with the significant 63% lower mortality [37‑79%] from meta analysis of the 7 mortality results to date.
risk of death, 71.5% lower, RR 0.29, p = 1.00, treatment 0 of 25 (0.0%), control 2 of 99 (2.0%), NNT 49, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 64.0% lower, RR 0.36, p = 0.46, treatment 1 of 25 (4.0%), control 11 of 99 (11.1%), NNT 14.
hospitalization time, 8.6% lower, relative time 0.91, p = 0.56, treatment mean 14.32 (±6.78) n=25, control mean 15.67 (±11.12) n=99.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Chae et al., 18 Mar 2022, retrospective, South Korea, peer-reviewed, mean age 57.6, 14 authors, study period 1 March, 2021 - 11 May, 2021. Contact: becareful123@uuh.ulsan.kr (corresponding author), margiela07@naver.com, 0735483@uuh.ulsan.kr, 0733808@uuh.ulsan.kr, docra@docra.pe.kr, yjjegal@uuh.ulsan.kr, jjahn@uuh.ulsan.kr, jjb@uuh.ulsan.kr, soyeoun.lim.xr@uuh.ulsan.kr, gamju@uuh.ulsan.kr, 0735496@uuh.ulsan.kr, 0735495@uuh.ulsan.kr, 0735779@uuh.ulsan.kr, tleepulalg@uuh.ulsan.kr.
This PaperRegdanvimabAll
The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study
Ganghee Chae, Aram Choi, Soyeoun Lim, Sooneun Park, Seungjun Lee, Youngick Ahn, Jinhyoung Kim, Seungwon Ra, Yangjin Jegal, Jongjoon Ahn, Eunji Park, Jaebum Jun, Woonjung Kwon, Taehoon Lee
Tropical Medicine and Infectious Disease, doi:10.3390/tropicalmed7030051
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 oxygenfree 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 (SpO 2 )/fraction of inspired oxygen (FiO 2 ) ratio (severity index). Further, in the regdanvimab/remdesivir group, the lowest SpO 2 /FiO 2 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.
Author Contributions: Conceptualization, G.C., A.C., W.K. and T.L.; Methodology, A.C., E.P. and T.L.; Formal Analysis, A.C., E.P. and T.L.; Data Curation, A.C. and T.L.; Writing-Original Draft Preparation, T.L.; Writing-Review & Editing, G.C., S.L., S.P., S.L., Y.A., J.K., S.R., Y.J., J.A. and J.J. All authors have read and agreed to the published version of the manuscript. Conflicts of Interest: The authors declare no conflict of interest.
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