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Clinical outcomes of mild to moderate coronavirus disease 2019 patients treated with Regdanvimab in delta-variant outbreak: Retrospective cohort study

Noh et al., Medicine, doi:10.1097/MD.0000000000035987
Nov 2023  
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35th treatment shown to reduce risk in March 2022
*, now known with p = 0.0000009 from 7 studies, recognized in 27 countries. Efficacy is variant dependent.
Lower risk for hospitalization, progression, and recovery.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments.
Retrospective 101 hospitalized COVID-19 patients in South Korea examining outcomes with the monoclonal antibody treatment regdanvimab, comparing 31 patients during the delta variant outbreak period to 49 patients with pre-delta variants. About 23% of patients needed oxygen therapy, with no significant difference between delta and pre-delta groups, though delta patients showed higher early risk of requiring oxygen. Around 46% of patients had adverse events, with no significant difference between groups.
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.
Noh et al., 10 Nov 2023, retrospective, Australia, peer-reviewed, 11 authors, study period 10 February, 2021 - 31 December, 2021. Contact:
This PaperRegdanvimabAll
Clinical outcomes of mild to moderate coronavirus disease 2019 patients treated with Regdanvimab in delta-variant outbreak: Retrospective cohort study
MD a , Hyeong-Jun Noh, MD, PhD a , Sin Jin Hwa Song, Sin Young Ham, MD a , Yeonkyung Park, MD, PhD Ha-Kyeong Won, MD c , Soo Jung Kim, M Keun Bum Chung, MD, PhD Choon Kwan Kim, MD a , Young Mee Ahn, MD a , Byoung-Jun Lee, MD Hye-Rin Kang
Medicine, doi:10.1097/md.0000000000035987
Regdanvimab is a novel neutralizing antibody agent used for the treatment of coronavirus disease 2019 (COVID-19). However, the effectiveness of regdanvimab in delta-variant patients has rarely been investigated. We examined the clinical outcomes and adverse events in COVID 19 patients treated with regdanvimab in the delta-variant era. Data were collected from laboratory-confirmed COVID-19 hospitalized patients who received regdanvimab in 2021 and categorized into pre-delta and delta variant groups. The primary outcome was the need for oxygen therapy. Rescue therapy, clinical improvement, and adverse events were analyzed. Among 101 patients treated with regdanvimab, 31 (30.7%) were delta patients and 49 (48.5) were pre-delta patients. 64.4% were male, the mean age was 60.3 years, and 70 patients (69%) had at least one underlying disease. The median interval from symptom onset to injection was 4 days. Twenty-three patients (23%) needed oxygen therapy, including 9 (29%) in the delta and 8 (16.3%) in the pre-delta group. (P = .176) The risk of early oxygen supplement was higher in the delta group (adjusted hazard ratio (aHR), 6.75; 95% confidence interval(CI), 1.53-29.8). The in-hospital survival rate was 100%, and no patients were admitted to the intensive care unit. Adverse events occurred in 43% of patients:13 (42%) delta patients and 23 (47%) pre-delta patients had any adverse events (P = .661). Patients treated with regdanvimab 4 days after symptom onset showed a favorable prognosis (aHR, 0.26; 95% CI, 0.26-0.91). We found that the high-risk mild to moderate COVID-19 patients treated with regdanvimab showed similar disease progression in delta-variant patients and pre-delta variants; however, we need to be more closely observed delta-variant patients than those in the pre-delta group despite regdanvimab treatment due to rapid disease aggravation. Abbreviations: aHR = adjusted hazard ratio, CI = confidence interval, COVID-19 = coronavirus disease 2019, NEWS2 = National Early Warning Score 2, SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
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