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Published on: April 19, 2024
Clinical Effectiveness of Regdanvimab Treatment for Mild-to-Moderate COVID-19: A Retrospective Cohort Study
Young Rock Jang1, Yoon Ju Oh2, Jin Yong Kim1
1Division of Infectious Diseases, Department of Internal Medicine, Incheon Medical Center, Incheon, Republic of Korea.
Insights
Regdanvimab significantly reduced oxygen saturation deterioration in mild-to-moderate COVID-19 patients compared to standard care. This real-world evidence supports regdanvimab
Area of Science:
- Infectious Diseases
- Pulmonology
- Pharmacology
Background:
- Regdanvimab (CT-P59) demonstrated efficacy in reducing hospitalization and death in mild-to-moderate COVID-19 patients during Phase III trials.
- This study investigates the real-world effectiveness of regdanvimab in managing COVID-19 symptoms and progression.
Purpose of the Study:
- To evaluate the impact of regdanvimab compared to standard of care (SoC) on oxygen saturation levels in patients with COVID-19.
- To assess the clinical outcomes and treatment patterns associated with regdanvimab use in a real-world setting.
Main Methods:
- A retrospective cohort study was conducted on patients diagnosed with mild-to-moderate COVID-19 via RT-PCR.
- The primary endpoint was the incidence of peripheral capillary oxygen saturation (SpO2) <94% on room air up to day 28 post-treatment.
- Patient data included oxygen saturation, fever recovery, hospitalization duration, and need for supplemental oxygen or mechanical ventilation.
Main Results:
- Regdanvimab treatment resulted in a significantly lower proportion of patients experiencing SpO2 deterioration (13.4%) compared to SoC (39.5%).
- Fewer patients receiving regdanvimab required supplemental oxygen (23.6% vs. 52.1%) or remdesivir (14.2% vs. 43.2%).
- Hospitalization duration was shorter for regdanvimab recipients, with no reported deaths or need for mechanical ventilation.
Conclusions:
- Regdanvimab effectively prevents clinical deterioration, evidenced by improved oxygen saturation levels in mild-to-moderate COVID-19 patients.
- The real-world data supports regdanvimab as a valuable therapeutic option for managing COVID-19, reducing the need for oxygen support and shortening hospital stays.
Background:
In a Phase III study, regdanvimab (CT-P59) reduced the risk of hospitalization or death versus placebo in patients with mild-to-moderate coronavirus disease 2019 (COVID-19).
Purpose:
We performed a retrospective cohort study of patients with COVID-19 to examine the effect of regdanvimab versus standard of care (SoC) on oxygen saturation.
Methods:
We reviewed patients with mild-to-moderate COVID-19 confirmed by reverse transcription-polymerase chain reaction at a single hospital in the Republic of Korea. The primary efficacy end point was the proportion of patients deteriorating with peripheral capillary oxygen saturation <94% on room air up to day 28.
Results:
A total of 127 patients were treated for COVID-19 with regdanvimab, 190 with SoC. The proportion of patients deteriorating with peripheral capillary oxygen saturation <94% on room air up to day 28 was 13.4% with regdanvimab and 39.5% with SoC (P < 0.0001); median time (range) until sustained recovery of fever was 2.0 (0.2-14.8) and 4.2 (0.1-17.1) days, respectively. Supplemental oxygen was required by 23.6% of patients with regdanvimab and 52.1% with SoC (P<0.0001) for a mean of 6.3 and 8.7 days, respectively (P = 0.0113); no patients needed mechanical ventilation. Compared with SoC, hospitalization was shorter with regdanvimab (mean = 11.1 vs 13.6 days; 63.8% vs 31.6% discharged within 11 days; both P values < 0.0001). Fewer regdanvimab-treated patients required remdesivir (14.2% vs 43.2%; P < 0.0001). There were no deaths. Two patients had adverse reactions with regdanvimab.
Conclusions:
This real-world study indicates that regdanvimab can prevent deterioration in patients with mild-to-moderate COVID-19. (Curr Ther Res Clin Exp. 2022; 83:XXX-XXX).
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