ABSTRACT
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)
【저자키워드】 COVID-19, SARS-CoV-2, Retrospective study, regdanvimab, CT-P59, 【초록키워드】 coronavirus disease, mechanical ventilation, Hospitalization, Remdesivir, risk, oxygen, oxygen saturation, Deterioration, Fever, Patient, death, Placebo, Adverse reaction, deaths, phase, Mild-to-moderate, p value, Standard of care, retrospective cohort study, median time, SOC, single hospital, Prevent, Clin, Result, performed, proportion, required, reduced, treated, Two patient, indicate, discharged, sustained, efficacy end point, Exp, patients deteriorating, patients with COVID-19, peripheral capillary, 【제목키워드】 clinical,