학술논문
Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19
Document Type
article
Author
Evering, Teresa H; Chew, Kara W; Giganti, Mark J; Moser, Carlee; Pinilla, Mauricio; Wohl, David Alain; Currier, Judith S; Eron, Joseph J; Javan, Arzhang Cyrus; Bender Ignacio, Rachel; Margolis, David; Zhu, Qing; Ma, Ji; Zhong, Lijie; Yan, Li; D’Andrea Nores, Ulises; Hoover, Keila; Mocherla, Bharat; Choudhary, Manish C; Deo, Rinki; Ritz, Justin; Fischer, William A; Fletcher, Courtney V; Li, Jonathan Z; Hughes, Michael D; Smith, Davey; Daar, Eric S; Hosey, Lara; Roa, Jhoanna; Patel, Nilam; Colsh, Kelly; Rwakazina, Irene; Beck, Justine; Sieg, Scott; Cardoso, Sandra; Corado, Katya; Jagannathan, Prasanna; Jilg, Nikolaus; Perelson, Alan; Pillay, Sandy; Riviere, Cynthia; Singh, Upinder; Taiwo, Babafemi; Gottesman, Joan; Newell, Matthew; Pedersen, Susan; Dragavon, Joan; Jennings, Cheryl; Greenfelder, Brian; Murtaugh, William; Kosmyna, Jan; Gapara, Morgan; Shahkolahi, Akbar; Lacal, Verónica; Salusso, Diego; Nuñez, Sebastian; Rodrigo Rodriguez, Marcelo; Laborde, Luciana; Papasidero, Marcelo; Wehbe, Luis; Gonzalez, Mariana; Fernandez Voena, Felicitas; Alvarez, Tomas; Lopez, Amaru; Huhn, Virginia; Dieser, Pablo; Bordese, Fernando; Mussi, Marisa; de Carvalho Santana, Rodrigo; Bárbaro, Adriana Aparecida Tiraboschi; Santos, Breno; de Cássia Alves Lira, Rita; da Silva, Andre Luiz Machado; Ribeiro, Maria Pia Diniz; Soliva, Nathália; Vasconcellos, Eduardo; Ribeiro, Jorge Eurico; Enéas, Miriam Amaral; Pinto, Jorge
Source
Annals of Internal Medicine. 176(5)
Subject
Language
Abstract
BackgroundDevelopment of safe and effective SARS-CoV-2 therapeutics is a high priority. Amubarvimab and romlusevimab are noncompeting anti-SARS-CoV-2 monoclonal antibodies with an extended half-life.ObjectiveTo assess the safety and efficacy of amubarvimab plus romlusevimab.DesignRandomized, placebo-controlled, phase 2 and 3 platform trial. (ClinicalTrials.gov: NCT04518410).SettingNonhospitalized patients with COVID-19 in the United States, Brazil, South Africa, Mexico, Argentina, and the Philippines.PatientsAdults within 10 days onset of symptomatic SARS-CoV-2 infection who are at high risk for clinical progression.InterventionCombination of monoclonal antibodies amubarvimab plus romlusevimab or placebo.MeasurementsNasopharyngeal and anterior nasal swabs for SARS-CoV-2, COVID-19 symptoms, safety, and progression to hospitalization or death.ResultsEight-hundred and seven participants who initiated the study intervention were included in the phase 3 analysis. Median age was 49 years (quartiles, 39 to 58); 51% were female, 18% were Black, and 50% were Hispanic or Latino. Median time from symptom onset at study entry was 6 days (quartiles, 4 to 7). Hospitalizations and/or death occurred in 9 (2.3%) participants in the amubarvimab plus romlusevimab group compared with 44 (10.7%) in the placebo group, with an estimated 79% reduction in events (P