Dataset Information

Regdanvimab for patients with mild-to-moderate COVID-19: a retrospective cohort study and subgroup analysis of patients with the Delta variant.

ABSTRACT:

Objectives

To evaluate the efficacy and safety of regdanvimab, a neutralizing antibody, in patients with mild-to-moderate SARS-CoV-2 including against the Delta variant.

Methods

A single-center, retrospective, observational cohort study in adults with confirmed COVID-19. The primary end point was the proportion of patients deteriorating with peripheral oxygen saturation <90% in room air, requiring supplemental oxygen therapy above high flow, or experiencing mortality due to COVID-19 up to day 28.

Results

A total of 722 patients were eligible; 418 received regdanvimab and 304 received standard of care (SoC), of whom 71.1% (297/418, regdanvimab) and 37.8% (115/304, SoC) were infected with the Delta variant. The proportion of patients with a primary end point event was significantly lower with regdanvimab than SoC (3.1% vs 9.9%; difference: -6.8 [95% confidence interval: -10.9, -2.8]; P = 0.0002). A similar trend was observed in the Delta variant subgroup (regdanvimab, 2.7% vs SoC, 7.0%; difference -4.3 [95% confidence interval: -10.8, 0.2]; P = 0.0827). The secondary efficacy end points supported the primary analysis findings in the overall cohort and Delta variant subgroup. No new safety signals were identified.

Conclusion

Regdanvimab demonstrated clinical efficacy in the overall cohort and may provide a clinical benefit for patients with mild-to-moderate COVID-19 infected with the Delta variant.

SUBMITTER: Jang YR

PROVIDER: S-EPMC9822548 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Regdanvimab for patients with mild-to-moderate COVID-19: a retrospective cohort study and subgroup analysis of patients with the Delta variant.

Jang Young Rock YR Oh Yoon Ju YJ Kim Jin Yong JY

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 20230107

<h4>Objectives</h4>To evaluate the efficacy and safety of regdanvimab, a neutralizing antibody, in patients with mild-to-moderate SARS-CoV-2 including against the Delta variant.<h4>Methods</h4>A single-center, retrospective, observational cohort study in adults with confirmed COVID-19. The primary end point was the proportion of patients deteriorating with peripheral oxygen saturation <90% in room air, requiring supplemental oxygen therapy above high flow, or experiencing mortality due to COVID- ...[more]

PMID: 36623794

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Project description:BackgroundMonoclonal antibodies are a treatment option for patients with mild-to-moderate coronavirus disease (COVID-19). We investigated the effectiveness of regdanvimab, an anti-severe acute respiratory syndrome coronavirus-2 monoclonal antibody approved in Korea, in the treatment of patients with mild-to-moderate COVID-19.Materials and methodsMedical records of patients who were admitted to a COVID-19 designated hospital during the study period of February 1 to June 31 and met the indications for administration of regdanvimab were reviewed to assess baseline characteristics and clinical outcomes such as supplemental oxygen requirements, mortality, and length of hospitalization. Multivariable logistic regression analysis was conducted to identify factors associated with requiring supplemental oxygen. Subgroup analysis was performed according to the presence of pneumonia confirmed on a chest X-ray.ResultsThree hundred ninety-eight COVID-19 patients were included in the study, and 65 (16.3%) of them were administered regdanvimab. The proportion of patients requiring supplemental oxygen was significantly lower in the regdanvimab group than in the control group (6.2% vs. 20.1%, P = 0.007). There was no significant difference in mortality (0% vs. 1.5%, P >0.999) and the length of hospitalization (median: 10 days vs. 10 days, P = 0.267) between two groups. The multivariable analysis demonstrated that administration of regdanvimab was independently associated with lower oxygen supplement [odds ratio (OR): 0.20, 95% confidence interval (CI): 0.06 - 0.55, P = 0.004] after adjustment of potential risk factors related to supplemental oxygen including age, sex, chest X-ray abnormality, and underlying chronic kidney disease. Among the patients with pneumonia radiologically, administration of regdanvimab was also associated with lower risk of oxygen supplement (OR: 0.13, 95% CI: 0.02 - 0.46, P = 0.007).ConclusionRegdanvimab use was related to lower need for supplemental oxygen in patients with mild-to-moderate COVID-19 for the indications for administration of regdanvimab.

Project description:Background Immune-evading severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants are emerging continuously. The clinical effectiveness of monoclonal antibody agents that exhibit decreased in vitro activity against SARS-CoV-2 variants needs to be elucidated. Methods A nationwide, multicenter, retrospective cohort study was designed to evaluate the effectiveness of regdanvimab, an anti-SARS-CoV-2 monoclonal antibody agent. Regdanvimab was prescribed in South Korea before and after the emergence of the delta variant, against which the in vitro activity of regdanvimab was decreased but present. Mild to moderate coronavirus 2019 (COVID-19) patients with risk factors for disease progression who were admitted within seven days of symptom onset were screened in four designated hospitals between December 2020 and September 2021. The primary outcomes, O2 requirements and progression to severe disease within 21 days of admission, were compared between the regdanvimab and supportive care groups, with a subgroup analysis of delta variant–confirmed patients. Results A total of 2,214 mild to moderate COVID-19 patients were included, of whom 1,095 (49.5%) received regdanvimab treatment. In the analysis of the total cohort, significantly fewer patients in the regdanvimab group than the supportive care group required O2 support (18.4% vs. 27.1%, P < 0.001) and progressed to severe disease (4.0% vs. 8.0%, P < 0.001). In the multivariable analysis, regdanvimab was significantly associated with a decreased risk for O2 support (HR 0.677, 95% CI 0.561–0.816) and progression to severe disease (HR 0.489, 95% CI 0.337–0.709). Among the 939 delta-confirmed patients, O2 support (21.5% vs. 23.5%, P = 0.526) and progression to severe disease (4.2% vs. 7.3%, P = 0.055) did not differ significantly between the regdanvimab and supportive care groups. In the multivariable analyses, regdanvimab treatment was not significantly associated with a decreased risk for O2 support (HR 0.963, 95% CI 0.697–1.329) or progression to severe disease (HR 0.665, 95% CI 0.349–1.268) in delta-confirmed group. Conclusions Regdanvimab treatment effectively reduced progression to severe disease in the overall study population, but did not show significant effectiveness in the delta-confirmed patients. The effectiveness of dose increment of monoclonal antibody agents should be evaluated for variant strains exhibiting reduced susceptibility.

Dataset Information

Regdanvimab for patients with mild-to-moderate COVID-19: a retrospective cohort study and subgroup analysis of patients with the Delta variant.

Objectives

Methods

Results

Conclusion

Publications

Regdanvimab for patients with mild-to-moderate COVID-19: a retrospective cohort study and subgroup analysis of patients with the Delta variant.

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