Mickovski, Ivana and Buklioska Ilievska, Daniela (2021) 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. [Project]
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Abstract
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 (COVID-19).
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.
Keywords: 19; COVID; CT; P59; SARS-CoV-2; regdanvimab.
| Item Type: | Project |
|---|---|
| Subjects: | Medical and Health Sciences > Clinical medicine |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Ivana Mickovski |
| Date Deposited: | 26 Feb 2024 11:24 |
| Last Modified: | 26 Feb 2024 11:24 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/33763 |
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