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Effect of Regdanvimab on Mortality in Patients Infected with SARS-CoV-2 Delta Variants: A Propensity Score-Matched
Soyoon Hwang1, Nan Young Lee2, Eunkyung Nam1
1Division of Infectious Diseases, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, 807, Hoguk-ro, Buk-gu, Daegu, Republic of Korea.
Insights
Regdanvimab significantly reduced mortality and condition exacerbation in patients with the COVID-19 delta variant. This monoclonal antibody therapy offers a promising treatment option for severe COVID-19 cases.
Area of Science:
- Immunology
- Virology
- Pharmacology
Background:
- Regdanvimab is the first Korean-developed monoclonal antibody approved for treating COVID-19.
- The study focuses on the efficacy of regdanvimab in patients infected with the SARS-CoV-2 delta variant.
Purpose of the Study:
- To evaluate the therapeutic effectiveness of regdanvimab in patients diagnosed with the COVID-19 delta variant.
- To compare clinical outcomes between patients treated with regdanvimab and those who did not receive the treatment.
Main Methods:
- A retrospective review of electronic medical records from two Korean tertiary COVID-19 hospitals.
- Propensity-score matching (1:1) was used to compare outcomes based on age, admission severity, and vaccination status.
Main Results:
- After matching, 189 patients were in each group (regdanvimab vs. non-regdanvimab).
- The regdanvimab group showed significantly lower 30-day hospital mortality (0.0% vs. 1.6%), condition exacerbation rates (9.5% vs. 16.4%), and need for oxygen therapy (7.4% vs. 16.4%).
- Fewer patients in the regdanvimab group experienced a daily National Early Warning Score ≥ 5 from hospital day 2.
Conclusions:
- Regdanvimab demonstrated a significant reduction in condition exacerbation and mortality among patients with the COVID-19 delta variant.
- Streamlining drug approval processes during viral epidemics is recommended to enhance therapeutic accessibility.
- Institutional support is crucial for improving the availability and utilization of novel therapeutics.
Introduction:
Regdanvimab, a monoclonal antibody pharmaceutical, is the first Korean drug approved for treating coronavirus disease 2019 (COVID-19). We analyzed the therapeutic efficacy of regdanvimab in patients with the COVID-19 delta variant infection.
Methods:
We retrospectively reviewed the electronic medical records of patients hospitalized at two Korean tertiary COVID-19 hospitals with COVID-19 delta variant infection between May 26, 2021, and January 30, 2022. To analyze the therapeutic efficacy of regdanvimab, the patients were divided into regdanvimab and non-regdanvimab groups and were 1:1 propensity-score (PS)-matched on age, severity at admission, and COVID-19 vaccination history.
Results:
Of 492 patients, 262 (53.3%) and 230 (46.7%) were in the regdanvimab and non-regdanvimab groups, respectively. After PS matching the groups on age, severity at admission, and COVID-19 vaccination history, each group comprised 189 patients. The 30-day hospital mortality rates (0.0% vs. 1.6%, p = 0.030), proportions of patients with exacerbated conditions to severe/critical/died (9.5% vs. 16.4%, p = 0.047), proportions who received oxygen therapy because of pneumonia exacerbation (7.4% vs. 16.4%, p = 0.007), and proportions with a daily National Early Warning Score ≥ 5 from hospital day 2 were significantly lower in the regdanvimab group.
Conclusions:
We showed that regdanvimab reduced the exacerbation rates of conditions and mortality in patients with the COVID-19 delta variant infection. Thus, it is recommended to streamline the drug approval system during epidemics of new variant viruses to improve the availability and usage of therapeutics for patients. To facilitate this, relevant institutional support is required.
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