biostudies-literatureEvering THNCATS NIH HHSNIAID NIH HHS658-666https://www.ebi.ac.uk/biostudies/studies/S-EPMC10150320biostudies-literatureUnknown176(5)<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>NasopharyngAnnals of internal medicineSafety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19.PMC10150320UM1 AI069423UM1 AI106701UM1 AI069424UM1 AI069534UM1 AI068634UL1 TR000124UL1 TR001881UM1 AI068636UM1 AI069419P30 AI045008UM1 AI069481UM1 AI069463U01 AI069424UM1 AI069432Kosmyna JManentsa MAswad ALutz AGonzalez NGonzalez MGonzalez LMcGuffin SGonzalez Vergara FCantu LPatel NWilliams-Leber ED'Andrea Nores UFerrer EFerreira FGFTaylor DLewinski MLeon RMitha IFocil AJonkane OGuillory CBogan Herpel LLynch JMadlala Pde Carvalho Santana RTebas PRiviere CJain MMcClain RRamirez RSherer Dvan der Walt EHawkins CAzizad MBryan AMargolis DGotur DSantos BCheekati VDay DCCheekati PShea KEasley RWernick AMalvestutto CSlandzicki JAda Silva ALMBaer JNewell MSieg SMasilela MSLChow CGuzman LSullivano JMaranan AAtriss HGelman MHall CGiganti MJLopez AInnes JCMussi MAmaya JPPixler AQuinn RMoyano SSocorro EShahkolahi AHecker MPillay SHendrickx SRoa JLopez VCBRolle CPNagpal AIdarraga SZhu QSebe MMwelase NPresti RBukhman EAdonis THaddad FJilg NDooley KBenson CDeJesus ESoliva NHendler SEron JJMbali SRChristina KHaddad VSuarez RMSenthil SNakatani LBetancourt-Garcia MDavis DMehta SWeinstein DRibeiro MPDHosey LBarbaro AATHoover KPerelson ANeytman GHarber HFayssoux JWohl DAFortier SDaar ESBromberg BArar CZhong LArnold MJoubert LHoover SEShaik SJohnson MMahmoudi SRibeiro JEFichtenbaum CSwiatek JDentoni-Lasofsky DWesterman JAvery AZopo ATrentman SOkeke NLMocherla BLaborde LVeltman JJust JGapara MPerez JAlvarez TPfeffer MMPathak DGonzalez Rojas YVasconcellos EBender Ignacio RFarah HBordese FHernandez MPerez YRosa JEziri ELi JZDube MPCall RHussen NJCardoso SPedersen SMa JChoudhary MCGreenfelder BTurner-Gray KJagizarov ZFree ALCastro MGomez-Martinez MOsiyemi OPetrick FMalik AHughes LPatron FRiaz APham DNHuhn VFletcher CVKao WHGottesman JCedeno JEKarpf CWilkin ARosas GAziz MBennet JABeck JMcEvoy KDieser PBeck KMoser CWallan JEvering THMohapi LOakes JGandhi RRathore MVaughan LMaldonado VJuneja EChoudhary MHughes MDKim ASeagle HPinilla MMohata SMChew KWDeo RKeenan CVahed YLoftis AJAndrews NPlanchon MMcHarry KPullman JAndriunas OCicarella RManne JZwane ZFernandez Voena FFernandez ITaiwo BFernandez HJagannathan PChiperera TIzquierdo MBukhman YJavan ACWilkins ARuiz KMalla MColsh KVarughese RYawetz SBrumskine WKingsley JFischer WADragavon JRuiz AWelton LLuetkemeyer ALummus CNunez SEneas MAACTIV-2/A5401 Study TeamSalusso DDominguez MBHaile AMurtaugh WLacal VCoyne CJain MKSein NNMoonsamy SRoman EMonlux GWWehbe LNikolov BHeffner MJonsson CCurrier JSHazard-Jenkins HJennings CSingh USurber JGonzalez AIKhodabakhshian APestana LBerzins BCronin AFrias MVPulliam SDFetalvero KKompelien BWeston PBerardi JFolkens EWeston KTorna OBurns CMPinto JPillay-Ramaya LSpikes LMilstone ARodriguez GLetlape OHerman CVictoria YBHatlen TTripathi KKMbhele NHerman JLennox PWilliamson DRodrigo Rodriguez MMendez LMCaloura MMartinez NEROrdway JJYan LCorado KSmith Dde Cassia Alves Lira RRwakazina IRitz JLalloo Ude Morais Caporali JFJoseph NSnyman ECoetzer TClemency BPapasidero MBecker BShort WKhan SfalseSafety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19.<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>Nasopharyng2023-01-01T00:00:00Z2023 May2026-05-02T11:23:43.656Z2025-04-07T03:18:25.083ZS-EPMC101503203706827210.7326/M22-342810.7326/m22-3428