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Effectiveness of Regdanvimab Treatment in High-Risk COVID-19 Patients to Prevent Progression to Severe Disease

Lee et al., Frontiers in Immunology, doi:10.3389/fimmu.2021.772320

Nov 2021

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Regdanvimab

34th treatment shown to reduce risk in March 2022

^*, now known with p = 0.0000000045 from 10 studies, recognized in 27 countries. Efficacy is variant dependent.

Lower risk for mortality, hospitalization, progression, and recovery.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,100+ studies for 60+ treatments. c19early.org

Retrospective 778 mild COVID-19 patients showing significantly lower progression to severe disease with regdanvimab treatment.

Confounding by treatment propensity. This study analyzes a population where only a fraction of eligible patients received the treatment. Patients receiving treatment may be more likely to follow other recommendations, more likely to receive additional care, and more likely to use additional treatments that are not tracked in the data (e.g., nasal/oral hygiene c19early.org, c19early.org (B), vitamin D c19early.org (C), etc.) — either because the physician recommending regdanvimab also recommended them, or because the patient seeking out regdanvimab is more likely to be familiar with the efficacy of additional treatments and more likely to take the time to use them. Therefore, these kind of studies may overestimate the efficacy of treatments.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2, BA.4, BA.5 Haars, 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.1.1 Pochtovyi.

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risk of death, 58.9% lower, RR 0.41, p = 1.00, treatment 0 of 234 (0.0%), control 1 of 544 (0.2%), NNT 544, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).

risk of severe case, 82.4% lower, HR 0.18, p = 0.002, treatment 234, control 234, adjusted per study, propensity score matching, multivariable.

risk of oxygen therapy, 45.2% lower, HR 0.55, p = 0.05, treatment 234, control 234, adjusted per study, propensity score matching, multivariable.

time to discharge, 8.3% lower, relative time 0.92, p = 0.001, treatment 234, control 544.

risk of no hospital discharge, 76.8% lower, RR 0.23, p < 0.001, treatment 5 of 234 (2.1%), control 50 of 544 (9.2%), NNT 14.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Lee et al., 23 Nov 2021, retrospective, South Korea, peer-reviewed, 10 authors, study period 26 November, 2020 - 28 February, 2021. Contact: sshhissh@gmail.com, krpeck@skku.edu.

This Paper Regdanvimab All

Effectiveness of Regdanvimab Treatment in High-Risk COVID-19 Patients to Prevent Progression to Severe Disease

Ji Yeon Lee, Jee Young Lee, Jae-Hoon Ko, Miri Hyun, Hyun Ah Kim, Seongcheol Cho, Yong Dae Lee, Junghoon Song, Seunghwan Shin, Kyong Ran Peck

Frontiers in Immunology, doi:10.3389/fimmu.2021.772320

Objective: To evaluate clinical effectiveness of regdanvimab, a monoclonal antibody agent for treating coronavirus 2019 . Methods: A 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. Results: A 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 O 2 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 O 2 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). 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 SpO 2 < 97% and CRP elevation >1.5 mg/dL were common risk factors for O 2 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.

ETHICS STATEMENT The studies involving human participants were reviewed and approved by Samsung Medical Center. Written informed consent for participation was not required for this study in acc ordance with the national l egis lation and the institutional requirements. AUTHOR CONTRIBUTIONS JiL, JeL, J-HK, SS, and KP contributed to the conceptualization. JiL, JeL, J-HK, MH, HK, SC, YDL, JS, and SS, and KP contributed to the investigation. J-HK and SS contributed to the statistical analysis. KP contributed to the supervision. J-HK, SS, and KP contributed to the writing, review, and editing. All authors contributed to the article and approved the submitted version. SUPPLEMENTARY MATERIAL The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fimmu.2021.772320/ full#supplementary-material Conflict of Interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's Note: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. Copyright © 2021 Lee, Lee, Ko, Hyun, Kim, Cho, Lee, Song, Shin and Peck. This is..

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