{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Evering TH"],"funding":["NCATS NIH HHS","NIAID NIH HHS"],"pagination":["658-666"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10150320"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["176(5)"],"pubmed_abstract":["<h4>Background</h4>Development 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.<h4>Objective</h4>To assess the safety and efficacy of amubarvimab plus romlusevimab.<h4>Design</h4>Randomized, placebo-controlled, phase 2 and 3 platform trial. (ClinicalTrials.gov: NCT04518410).<h4>Setting</h4>Nonhospitalized patients with COVID-19 in the United States, Brazil, South Africa, Mexico, Argentina, and the Philippines.<h4>Patients</h4>Adults within 10 days onset of symptomatic SARS-CoV-2 infection who are at high risk for clinical progression.<h4>Intervention</h4>Combination of monoclonal antibodies amubarvimab plus romlusevimab or placebo.<h4>Measurements</h4>Nasopharyng"],"journal":["Annals of internal medicine"],"pubmed_title":["Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19."],"pmcid":["PMC10150320"],"funding_grant_id":["UM1 AI069423","UM1 AI106701","UM1 AI069424","UM1 AI069534","UM1 AI068634","UL1 TR000124","UL1 TR001881","UM1 AI068636","UM1 AI069419","P30 AI045008","UM1 AI069481","UM1 AI069463","U01 AI069424","UM1 AI069432"],"pubmed_authors":["Kosmyna J","Manentsa M","Aswad A","Lutz A","Gonzalez N","Gonzalez M","Gonzalez L","McGuffin S","Gonzalez Vergara F","Cantu L","Patel N","Williams-Leber E","D'Andrea Nores U","Ferrer E","Ferreira FGF","Taylor D","Lewinski M","Leon R","Mitha I","Focil A","Jonkane O","Guillory C","Bogan Herpel L","Lynch J","Madlala P","de Carvalho Santana R","Tebas P","Riviere C","Jain M","McClain R","Ramirez R","Sherer D","van der Walt E","Hawkins C","Azizad M","Bryan A","Margolis D","Gotur D","Santos B","Cheekati V","Day DC","Cheekati P","Shea K","Easley R","Wernick A","Malvestutto C","Slandzicki JA","da Silva ALM","Baer J","Newell M","Sieg S","Masilela MSL","Chow C","Guzman L","Sullivano J","Maranan A","Atriss H","Gelman M","Hall C","Giganti MJ","Lopez A","Innes JC","Mussi M","Amaya JP","Pixler A","Quinn R","Moyano S","Socorro E","Shahkolahi A","Hecker M","Pillay S","Hendrickx S","Roa J","Lopez VCB","Rolle CP","Nagpal A","Idarraga S","Zhu Q","Sebe M","Mwelase N","Presti R","Bukhman E","Adonis T","Haddad F","Jilg N","Dooley K","Benson C","DeJesus E","Soliva N","Hendler S","Eron JJ","Mbali SR","Christina K","Haddad V","Suarez RM","Senthil S","Nakatani L","Betancourt-Garcia M","Davis D","Mehta S","Weinstein D","Ribeiro MPD","Hosey L","Barbaro AAT","Hoover K","Perelson A","Neytman G","Harber H","Fayssoux J","Wohl DA","Fortier S","Daar ES","Bromberg B","Arar C","Zhong L","Arnold M","Joubert L","Hoover SE","Shaik S","Johnson M","Mahmoudi S","Ribeiro JE","Fichtenbaum C","Swiatek J","Dentoni-Lasofsky D","Westerman J","Avery A","Zopo A","Trentman S","Okeke NL","Mocherla B","Laborde L","Veltman J","Just J","Gapara M","Perez J","Alvarez T","Pfeffer MM","Pathak D","Gonzalez Rojas Y","Vasconcellos E","Bender Ignacio R","Farah H","Bordese F","Hernandez M","Perez Y","Rosa J","Eziri E","Li JZ","Dube MP","Call R","Hussen NJ","Cardoso S","Pedersen S","Ma J","Choudhary MC","Greenfelder B","Turner-Gray K","Jagizarov Z","Free AL","Castro M","Gomez-Martinez M","Osiyemi O","Petrick F","Malik A","Hughes L","Patron F","Riaz A","Pham DN","Huhn V","Fletcher CV","Kao WH","Gottesman J","Cedeno JE","Karpf C","Wilkin A","Rosas G","Aziz M","Bennet JA","Beck J","McEvoy K","Dieser P","Beck K","Moser C","Wallan J","Evering TH","Mohapi L","Oakes J","Gandhi R","Rathore M","Vaughan L","Maldonado V","Juneja E","Choudhary M","Hughes MD","Kim A","Seagle H","Pinilla M","Mohata SM","Chew KW","Deo R","Keenan C","Vahed Y","Loftis AJ","Andrews N","Planchon M","McHarry K","Pullman J","Andriunas O","Cicarella R","Manne J","Zwane Z","Fernandez Voena F","Fernandez I","Taiwo B","Fernandez H","Jagannathan P","Chiperera T","Izquierdo M","Bukhman Y","Javan AC","Wilkins A","Ruiz K","Malla M","Colsh K","Varughese R","Yawetz S","Brumskine W","Kingsley J","Fischer WA","Dragavon J","Ruiz A","Welton L","Luetkemeyer A","Lummus C","Nunez S","Eneas MA","ACTIV-2/A5401 Study Team","Salusso D","Dominguez MB","Haile A","Murtaugh W","Lacal V","Coyne C","Jain MK","Sein NN","Moonsamy S","Roman E","Monlux GW","Wehbe L","Nikolov B","Heffner M","Jonsson C","Currier JS","Hazard-Jenkins H","Jennings C","Singh U","Surber J","Gonzalez AI","Khodabakhshian A","Pestana L","Berzins B","Cronin A","Frias MV","Pulliam SD","Fetalvero K","Kompelien B","Weston P","Berardi J","Folkens E","Weston K","Torna O","Burns CM","Pinto J","Pillay-Ramaya L","Spikes L","Milstone A","Rodriguez G","Letlape O","Herman C","Victoria YB","Hatlen T","Tripathi KK","Mbhele N","Herman J","Lennox P","Williamson D","Rodrigo Rodriguez M","Mendez LM","Caloura M","Martinez NER","Ordway JJ","Yan L","Corado K","Smith D","de Cassia Alves Lira R","Rwakazina I","Ritz J","Lalloo U","de Morais Caporali JF","Joseph N","Snyman E","Coetzer T","Clemency B","Papasidero M","Becker B","Short W","Khan S"],"additional_accession":[]},"is_claimable":false,"name":"Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19.","description":"<h4>Background</h4>Development 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.<h4>Objective</h4>To assess the safety and efficacy of amubarvimab plus romlusevimab.<h4>Design</h4>Randomized, placebo-controlled, phase 2 and 3 platform trial. (ClinicalTrials.gov: NCT04518410).<h4>Setting</h4>Nonhospitalized patients with COVID-19 in the United States, Brazil, South Africa, Mexico, Argentina, and the Philippines.<h4>Patients</h4>Adults within 10 days onset of symptomatic SARS-CoV-2 infection who are at high risk for clinical progression.<h4>Intervention</h4>Combination of monoclonal antibodies amubarvimab plus romlusevimab or placebo.<h4>Measurements</h4>Nasopharyng","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 May","modification":"2026-05-02T11:23:43.656Z","creation":"2025-04-07T03:18:25.083Z"},"accession":"S-EPMC10150320","cross_references":{"pubmed":["37068272"],"doi":["10.7326/M22-3428","10.7326/m22-3428"]}}