Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019
Anca Streinu-Cercel, Oana Săndulescu, Liliana-Lucia Preotescu, Jin Yong Kim, Yeon-Sook Kim, Shinhye Cheon, Young Rock Jang, Sang Joon Lee, Sung Hyun Kim, Ilsung Chang, Jee Hye Suh, Seul Gi Lee, Mi Rim Kim, Da Rae Chung, Han Na Kim, Adrian Streinu-Cercel, MD Joong Sik Eom
Open Forum Infectious Diseases, doi:10.1093/ofid/ofac053
Background. Regdanvimab (CT-P59) is a monoclonal antibody with neutralizing activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report on part 1 of a 2-part randomized, placebo-controlled, double-blind study for patients with mild-to-moderate coronavirus disease 2019 . Methods. Outpatients with mild-to-moderate COVID-19 received a single dose of regdanvimab 40 mg/kg (n = 100), regdanvimab 80 mg/kg (n = 103), or placebo (n = 104). The primary end points were time to negative conversion of SARS-CoV-2 from nasopharyngeal swab based on quantitative reverse transcription polymerase chain reaction (RT-qPCR) up to day 28 and time to clinical recovery up to day 14. Secondary end points included the proportion of patients requiring hospitalization, oxygen therapy, or mortality due to COVID-19. Results. Median (95% CI) time to negative conversion of RT-qPCR was 12.8 (9.0-12.9) days with regdanvimab 40 mg/kg, 11.9 (8.9-12.9) days with regdanvimab 80 mg/kg, and 12.9 (12.7-13.9) days with placebo. Median (95% CI) time to clinical recovery was 5.3 (4.0-6.8) days with regdanvimab 40 mg/kg, 6.2 (5.5-7.9) days with regdanvimab 80 mg/kg, and 8.8 (6.8-11.6) days with placebo. The proportion (95% CI) of patients requiring hospitalization or oxygen therapy was lower with regdanvimab 40 mg/kg (4.0% [1.6%-9.8%]) and regdanvimab 80 mg/kg (4.9% [2.1%-10.9%]) vs placebo (8.7% [4.6%-15.6%]). No serious treatment-emergent adverse events or deaths occurred. Conclusions. Regdanvimab showed a trend toward a minor decrease in time to negative conversion of RT-qPCR results compared with placebo and reduced the need for hospitalization and oxygen therapy in patients with mild-to-moderate COVID-19. Clinical trial registration. NCT04602000 and EudraCT 2020-003369-20.
Supplementary Data Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author.
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'abstract': '<jats:title>Abstract</jats:title>\n'
' <jats:sec>\n'
' <jats:title>Background</jats:title>\n'
' <jats:p>Regdanvimab (CT-P59) is a monoclonal antibody with neutralizing '
'activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report on '
'part 1 of a 2-part randomized, placebo-controlled, double-blind study for mild-to-moderate '
'patients with coronavirus disease 2019 (COVID-19).</jats:p>\n'
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' <jats:sec>\n'
' <jats:title>Methods</jats:title>\n'
' <jats:p>Outpatients with mild-to-moderate COVID-19 received a single dose '
'of regdanvimab 40\xa0mg/kg (n=100), regdanvimab 80\xa0mg/kg (n=103), or placebo (n=104). '
'Primary endpoints were time to negative conversion of SARS-CoV-2 from nasopharyngeal swab '
'based on quantitative reverse transcription polymerase chain reaction (RT-qPCR) up to day 28 '
'and time to clinical recovery up to day 14. Secondary endpoints included the proportion of '
'patients requiring hospitalization, oxygen therapy, or mortality due to COVID-19.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Results</jats:title>\n'
' <jats:p>Median (95% confidence interval [CI]) time to negative conversion '
'of RT-qPCR was 12.8 days (9.0–12.9) with regdanvimab 40\xa0mg/kg, 11.9 days (8.9–12.9) with '
'regdanvimab 80\xa0mg/kg, and 12.9 days (12.7–13.9) with placebo. Median (95% CI) time to '
'clinical recovery was 5.3 days (4.0–6.8) with regdanvimab 40\xa0mg/kg, 6.2 days (5.5–7.9) '
'with regdanvimab 80\xa0mg/kg, and 8.8 days (6.8–11.6) with placebo. The proportion (95% CI) '
'of patients requiring hospitalization or oxygen therapy was lower with regdanvimab 40\xa0'
'mg/kg (4.0% [1.6–9.8]) and regdanvimab 80\xa0mg/kg (4.9% [2.1–10.9]) versus placebo (8.7% '
'[4.6–15.6). No serious treatment-emergent adverse events or deaths occurred.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Conclusions</jats:title>\n'
' <jats:p>Regdanvimab showed a trend toward a minor decrease in time to '
'negative conversion of RT-qPCR results compared with placebo and reduced the need for '
'hospitalization and oxygen therapy in patients with mild-to-moderate COVID-19.</jats:p>\n'
' </jats:sec>',
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