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Financial Support: By the U.S. Operation Warp Speed program; the National Institute of Allergy and Infectious Diseases and Leidos Biomedical Research for the INSIGHT Network; the National Heart, Lung, and Blood Institute and the Research Triangle Institute for the Prevention and Early Treatment of Acute Lung Injury Network and the Cardiothoracic Surgical Trials Network; the U.S. Department of Veterans Affairs; and grants from the governments of Denmark (no. 126 from the National Research Foundation) , Australia (from the National Health and Medical Research Council) , the United Kingdom (MRC_UU_12023/23 from the Medical Research Council) , and Singapore (COVID19RF-005 from the National Medical Research Council) . The research was funded in part by National Institutes of Health agreement 1OT2HL156812-01 and National Cancer Institute contract 75N91019D00024, task order 75N91020F00039. Trial medica-tions were donated by Molecular Partners (ensovibep) and Gilead Sciences (remdesivir) .

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Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19: A Randomized Controlled Trial

Publicated to:Annals Of Internal Medicine. 175 (9): 1266-+ - 2022-08-09 175(9), DOI: 10.7326/M22-1503

Authors: Barkauskas, Christina; Mylonakis, Eleftherios; Poulakou, Garyfallia; Young, Barnaby E; Vock, David M; Siegel, Lianne; Engen, Nicole; Grandits, Greg; Mosaly, Nilima R; Vekstein, Andrew M; Rogers, Ralph; Shehadeh, Fadi; Kaczynski, Matthew; Mylona, Evangelia K; Syrigos, Konstantinos N; Rapti, Vasiliki; Lye, David C; Hui, Diong Shiau; Leither, Lindsay; Knowlton, Kirk U; Jain, Mamta K; Marines-Price, Rubria; Osuji, Alice; Overcash, J Scott; Kalomenidis, Ioannis; Barmparessou, Zafeiria; Waters, Michael; Zepeda, Karla; Chen, Peter; Torbati, Sam; Kiweewa, Francis; Sebudde, Nicholus; Almasri, Eyad; Hughes, Alyssa; Bhagani, Sanjay R; Rodger, Alison; Sandkovsky, Uriel; Gottlieb, Robert L; Nnakelu, Eriobu; Trautner, Barbara; Menon, Vidya; Lutaakome, Joseph; Robinson, Philip; Protopapas, Konstantinos; Koulouris, Nikolaos; Kimuli, Ivan; Baduashvili, Amiran; Braun, Dominique L; Gunthard, Huldrych F; Ramachandruni, Srikanth; Kidega, Robert; Kim, Kami; Hatlen, Timothy J; Phillips, Andrew N; Murray, Daniel D; Jensen, Tomas O; Accardi, Evan X; Shaw-Saliba, Katy; Dewar, Robin L; Teitelbaum, Marc; Natarajan, Ven; Laverdure, Sylvain; Highbarger, Helene C; Rehman, M Tauseef; Vogel, Susan; Vallee, David; Crew, Page; Atri, Negin; Schechner, Adam J; Pett, Sarah; Hudson, Fleur; Badrock, Jonathan; Touloumi, Giota; Self, Wesley H; North, Crystal M; Ginde, Adit A; Chang, Christina C; Kelleher, Anthony; Nagy-Agren, Stephanie; Vasudeva, Shikha; Looney, David; Nguyen, Hien H; Sanchez, Adriana; Weintrob, Amy C; Grund, Birgit; Sharma, Shweta; Reilly, Cavan S; Paredes, Roger; Gerry, Norman P; Babiker, Abdel G; Davey, Victoria J; Gelijns, Annetine C; Higgs, Elizabeth S; Kan, Virginia; Matthews, Gail; Thompson, B Taylor; Legenne, Philippe; Chandra, Richa; Lane, H Clifford; Neaton, James D; Lundgren, Jens D; Sahner, David; Tierney, John; Herpin, Betsey R; Smolskis, Mary C; McKay, Laura A; Cahill, Kelly; Sardana, Ratna; Raim, Sharon Segal; Hensely, Lisa; Lorenzo, Joshua; Mock, Rebecca; Zuckerman, Judith; Miller, Mark; Chung, Lucy; Kang, Nayon; Adam, Stacey J; Read, Sarah; Draghia-Akli, Ruxandra; Carlsen, Amy; Carter, Anita; Denning, Eileen; DuChene, Alain; Eckroth, Kate; Frase, Alex; Harrison, Merrie; Kaiser, Payton; Koopmeiners, Joseph; Meger, Sue; Murray, Thomas; Quan, Kien; Quan, Siu Fun; Thompson, Greg; Walski, Jamie; Wentworth, Deborah; Moskowitz, Alan J; Bagiella, Emilia; Moquete, Ellen; O'Sullivan, Karen; Marks, Mary E; Kinzel, Emily; Burris, Sarah; Bedoya, Gabriela; Gupta, Lola; Overbey, Jessica R; Padillia, Maria L; Santos, Milerva; Gillinov, Marc A; Miller, Marissa A; Taddei-Peters, Wendy C; Fenton, Kathleen; Mack, Michael; Berhe, Mezgebe; Haley, Clinton; Dishner, Emma; Bettacchi, Christopher; Golden, Kevin; Duhaime, Erin; Ryan, Madison; Tallmadge, Catherine; Estrada, Lorie; Jones, Felecia; Villa, Samatha; Wang, Samatha; Robert, Raven; Coleman, Tanquinisha; Clariday, Laura; Baker, Rebecca; Hurutado-Rodriguez, Mariana; Iram, Nazia; Fresnedo, Michelle; Davis, Allyson; Leonard, Kiara; Ramierez, Noelia; Thammavong, Jon; Duque, Krizia; Turner, Emma; Fisher, Tammy; Robinson, Dianna; Ransom, Desirae; Maldonado, Nicholas; Lusk, Erica; Killian, Aaron; Palacious, Adriana; Solis, Edilia; Jerrow, Janet; Watts, Matthew; Whitacre, Heather; Cothran, Elizabeth; Smith, Peter K; Ko, Emily R; Dreyer, Grace R; Stafford, Neil; Brooks, Megan; Der, Tatyana; Witte, Marie; Gamarallage, Ruwan; Franzone, John; Ivey, Noel; Lumsden, Rebecca H; Mourad, Ahmaad; Holland, Thomas L; Motta, Mary; Lane, Kathleen; McGowan, Lauren M; Stout, Jennifer; Aloor, Heather; Bragg, Kennesha M; Toledo, Barvina; McLendon-Arvik, Beth; Bussadori, Barbara; Hollister, Beth A; Griffin, Michelle; Giangiacomo, Dana M; Rodriguez, Vicente; Parrino, Patrick E; Spindel, Stephen; Bansal, Aditya; Baumgarten, Katherine; Hand, Johnathan; Vonderhaar, Derek; Nossaman, Bobby; Laudun, Sylvia; Ames, DeAnna; Broussard, Shane; Hernandez, Nilmo; Isaac, Geralyn; Dinh, Huan; Zheng, Yiling; Tran, Sonny; McDaniel, Hunter; Crovetto, Nicolle; Perin, Emerson; Costello, Briana; Manian, Prasad; Sohail, M Rizwan; Postalian, Alexander; Hinsu, Punit; Watson, Carolyn; Chen, James; Fink, Melyssa; Sturgis, Lydia; Kim, Walker; Mahon, Kim; Parenti, Jennifer; Kappenman, Casey; Knight, Aryn; Sturek, Jeffrey M; Barros, Andrew; Enfield, Kyle B; Kadl, Alexandra; Green, China J; Simon, Rachel M; Fox, Ashley; Thornton, Kara; Adams, Amy; Traverse, Jay H; Rhame, Frank; Huelster, Joshua; Kethireddy, Rajesh; Salamanca, Julianne; Majeski, Christine; Skelton, Paige; Zarambo, Maria; Sarafolean, Andrea; Oldmixon, Cathryn; Ringwood, Nancy; Muzikansky, Ariela; Morse, Richard; Brower, Roy G; Reineck, Lora A; Aggarwal, Neil R; Bienstock, Karen; Steingrub, Jay H; Hou, Peter K; Steingrub, Jay S; Tidswell, Mark A; Kozikowski, Lori-Ann; Kardos, Cynthia; DeSouza, Leslie; Romain, Sarah; Talmor, Daniel; Shapiro, Nathan; Andromidas, Konstantinos; Banner-Goodspeed, Valerie; Bolstad, Michael; Boyle, Katherine L; Cabrera, Payton; deVilla, Arnaldo; Ellis, Joshua C; Grafals, Ana; Hayes, Sharon; Higgins, Conor; Kurt, Lisa; Kurtzman, Nicholas; Redman, Kimberly; Rosseto, Elinita; Scaffidi, Douglas; Filbin, Michael R; Hibbert, Kathryn A; Parry, Blair; Margolin, Justin; Hillis, Brooklynn; Hamer, Rhonda; Jones, Alan E; Galbraith, James; Nandi, Utsav; Hendey, Gregory; Matthay, Michael A; Kangelaris, Kirsten; Ashktorab, Kimia; Gropper, Rachel; Agrawal, Anika; Fayed, Mohamed; Hubel, Kinsley A; Garcia, Rebekah L; Lim, George W; Chang, Steven Y; Lin, Michael Y; Vargas, Julia; Sihota, Hena; Beutler, Rebecca; Rogers, Angela J; Wilson, Jennifer G; Vojnik, Rosemary; Perez, Cynthia; McDowell, Jordan H; Albertson, Timothy; Hardy, Erin; Harper, Richart; Moss, Marc A; Chauhan, Lakshmi; Douin, David J; Martinez, Flora; Finck, Lani L; Bastman, Jill; Hyzy, Robert C; Park, Pauline K; Nelson, Kristine; McSparron, Jake I; Co, Ivan N; Wang, Bonnie R; Jimenez, Jose; Sullins, Barbara; Olbrich, Norman; Gong, Michelle N; Richardson, Lynne D; Nair, Rahul; Lopez, Brenda; Amosu, Omowunmi; Tzehaie, Hiwet; Nkemdirim, William; Boujid, Sabah; Mosier, Jarrod M; Hypes, Cameron; Campbell, Elizabeth Salvagio; Bixby, Billie; Gilson, Boris; Lopez, Anitza; Hite, R Duncan; Terndrup, Thomas E; Wiedemann, Herbert P; Hudock, Kristin; Tanzeem, Hammad; More, Harshada; Martinkovic, Jamie; Sellers, Susan; Houston, Judy; Burns, Mary; Robinson, Bryce H; Hough, Catherine L; Khan, Akram; Krol, Olivia F; Mills, Emmanuel; Kinjal, Mistry; Briceno, Genesis; Reddy, Raju; Hubel, Kinsley; Parimon, Tanyalak; Caudill, Antonina; Mattison, Brittany; Jackman, Susan E; Chen, Po-En; Bayoumi, Emad; Ojukwu, Cristabelle; Fine, Devin; Weissberg, Gwendolyn; Isip, Katherine; Choi-Kuaea, Yunhee; Mehdikhani, Shaunt; Dar, Tahir B; Augustin, Nsole Biteghe Fleury; Tran, Dana; Dukov, Jennifer Emilow; O'Mahony, D Shane; Wilson, David M; Wallick, Julie A; Duven, Alexandria M; Fletcher, Dakota D; Files, D Clark; Miller, Chadwick; Gibbs, Kevin W; Flores, Lori S; LaRose, Mary E; Landreth, Leigha D; Palacios, D Rafael; Parks, Lisa; Hicks, Madeline; Goodwin, Andrew J; Kilb, Edward F; Lematty, Caitlan T; Patti, Kerilyn; Bledsoe, Joseph; Brown, Samuel; Lanspa, Michael; Pelton, Ithan; Armbruster, Brent P; Montgomery, Quinn; Kumar, Naresh; Fergus, Melissa; Imel, Karah; Palmer, Ghazal; Webb, Brandon; Klippel, Carolyn; Jensen, Hannah; Duckworth, Sarah; Gray, Andrew; Burke, Tyler; Knox, Dan; Lumpkin, Jenna; Aston, Valerie T; Rice, Todd W; Casey, Jonathan D; Johnson, Jakea; Hays, Margaret; Kasubhai, Moiz; Pillai, Anjana; Daniel, Jean; Sittler, Daniel; Kanna, Balavenkatesh; Jilani, Nargis; Amaro, Francisco; Santana, Jessica; Lyakovestsky, Aleksandr; Madhoun, Issa; Desroches, Louis Marie; Amadon, Nicole; Bahr, Alaa; Ezzat, Imaan; Guerrero, Maryanne; Padilla, Joane; Fullmer, Jessie; Singh, Inderpreet; Shah, Syed Hamad Ali; Narang, Rajeev; Mock, Polly; Shadle, Melissa; Hernandez, Brenda; Welch, Kevin; Payne, Andrea; Ertl, Gabriela; Canario, Daniel; Barrientos, Isabel; Goss, Danielle; DeVries, Mattie; Folowosele, Ibidolapo; Garner, Dorothy; Gomez, Mariana; Price, Justin; Bansal, Ekta; Wong, Jim; Faulhaber, Jason; Fazili, Tasaduq; Yeary, Brian; Ndolo, Ruth; Bryant, Christina; Smigeil, Bridgette; Najjar, Rana; Jones, Patrice; Nguyen, Julie; Chin, Christina; Taha, Hassan; Najm, Salah; Smith, Christopher; Moore, Jason; Nassar, Talal; Gallinger, Nick; Christian, Amy; Mauer, D'Amber; Phipps, Ashley; Coslet, Jordan; Landazuri, Rosalynn; Pineda, Jacob; Uribe, Nicole; Garcia, Jose Ruiz; Barbabosa, Cecilia; Sandler, Kaitlyn; Marquez, Adrienna; Chu, Hanh; Lee, Kia; Quillin, Kimberly; Garcia, Andrea; Lew, Pauline; Tran, Quynh-Lam; Benitez, Gregorio; Mishra, Biswajit; Felix, Lewis Oscar; Vafea, Maria Tsikala; Atalla, Eleftheria; Davies, Robin; Hedili, Salma; Monkeberg, Maria Andrea; Tabler, Sandra; Harrington, Britt; Popielski, Laura; Kambo, Amy; Viens, Kimberley; Turner, Melissa; Vjecha, Michael J; Cha, Christine; Mozaffari, Azadeh; Hernandez, Rosa; Agbor, Barbine Tchamba Agbor; Petersen, Tianna; Kamel, Dena; Hansen, Laura; Garcia, Angie; Kim, Mina; DellaValle, Natalie; Gonzales, Sonia; Somboonwit, Charurut; Oxner, Asa; Guerra, Lucy; Tran, Thanh; Pinto, Avenette; Anderson, Betty; Zepeda-Gutierrez, Ana; Martin, Dannae; Temblador, Cindi; Cuenca, Avon; Guerrero, Mario; Daar, Eric; Correa, Ramiro; Hartnell, Gabe; Wortmann, Glenn; Doshi, Saumil; Moriarty, Theresa; Gonzales, Melissa; Garman, Kristin; Baker, Jason V; Frosch, Anne; Goldsmith, Rachael; Jibrell, Hodan; Lo, Melanie; Klaphake, Jonathan; Mackedanz, Shari; Ngo, Linh; Garcia-Myers, Kelly; Kunisaki, Ken M; Hassler, Miranda; Walquist, Mary; Augenbraun, Michael; Dehovitz, Jack; Abassi, Mahsa; Leuck, Anne-Marie; Rao, Via; Biswas, Kousick; Harrington, Cristin; Garcia, Amanda; Bremer, Tammy; Koker, Brittany; Davis-Karim, Anne; Pittman, David; Vasudeva, Shikha S; Pandit, Lavannya; Hines-Munson, Casey; Van, John; Dillon, Laura; Wang, Yiqun; Ochalek, Tracy; Caldwell, Erin; Humerickhouse, Edward; Boone, David; McGraw, William; Mehta, Sanjay R; Johns, Scott Thompson; St John, Melissa; Raceles, Jacqueline; Sear, Emily; Funk, Stephen; Cesarini, Rosa; Fang, Michelle; Nicalo, Keith; Drake, Wonder; Jones, Beatrice; Holtman, Teresa; Maniar, Archana; Johnson, Eric A; Nguyen, Lam; Tran, Michelle T; Barrett, Thomas W; Johnston, Tera; Huggins, John T; Beiko, Tatsiana Y; Hughes, Heather Y; McManigle, William C; Tanner, Nichole T; Washburn, Ronald G; Ardelt, Magdalena; Tuohy, Patricia A; Mixson, Jennifer L; Hinton, Charles G; Thornley, Nicola; Allen, Heather; Elam, Shannon; Boatman, Barry; Baber, Brittany J; Ryant, Rudell; Roller, Brentin; Chinh Nguyen; Mikail, Amani Morgan; Hansen, Marivic; Lichtenberger, Paola; Baracco, Gio; Ramos, Carol; Bjork, Lauren; Sueiro, Melyssa; Tien, Phyllis; Freasier, Heather; Buck, Theresa; Nekach, Hafida; Holodniy, Mark; Chary, Aarthi; Lu, Kan; Peters, Theresa; Lopez, Jessica; Tan, Susanna Yu; Lee, Robert H; Asghar, Aliya; Karim, Tasadduq; Isip, Karyn; Le, Katherine; Thao Nguyen; Wong, Shinn; Raben, Dorthe; Aagaard, Bitten; Nielsen, Charlotte B; Krapp, Katharina; Nykjaer, Bente Rosdahl; Olsson, Christina; Kanne, Katja Lisa; Grevsen, Anne Louise; Joensen, Zillah Maria; Bojesen, Ane; Woldbye, Frederik; Normand, Nick E; Benfield, Thomas; Clausen, Clara Lundetoft; Hovmand, Nichlas; Israelsen, Simone Bastrup; Iversen, Katrine; Leding, Caecilie; Pedersen, Karen Brorup; Thorlacius-Ussing, Louise; Tinggaard, Michaela; Tingsgard, Sandra; Jensen, Jens-Ulrik Staehr; Overgaard, Rikke; Rastoder, Ema; Heerfordt, Christian; Hedsund, Caroline; Ronn, Christian Phillip; Kamstrup, Peter Thobias; Hogsberg, Dorthe Sandbaek; Bergsoe, Christina; Ostergaard, Lars; Staerke, Nina Breinholt; Yehdego, Yordanos; Sondergaard, Ane; Johansen, Isik S; Holden, Inge K; Lindvig, Susan O; Helleberg, Marie; Gerstoft, Jan; Kirk, Ole; Bruun, Tina; Jensen, Tomas Ostergaard; Madsen, Birgitte Lindegaard; Pedersen, Thomas Ingemann; Harboe, Zitta Barrella; Roge, Birgit Thorup; Hansen, Thomas Michael; Glesner, Matilde Kanstrup; Lofberg, Sandra Valborg; Nielsen, Ariella Denize; Nielsen, Henrik; Thisted, Rikke Krog; Petersen, Kristine Toft; Juhl, Maria Ruwald; Podlekareva, Daria; Johnsen, Stine; Wiese, Lothar; Knudsen, Lene Surland; Exposito, Maria; Badillo, Jose; Martinez, Ana; Abad, Elena; Chamorro, Ana; Mateu, Lourdes; Espana, Sergio; Constanza Lucero, Maria; Ramon Santos, Jose; Llados, Gemma; Lopez, Cristina; Carabias, Lydia; Fernandez-Cruz, Eduardo; Di Natale, Marisa; Padure, Sergiu; Gomez, Jimena; Ausin, Cristina; Cervilla, Eva; Balastegui, Hector; Rodriguez Sainz, Carmen; Escobar, Mariam; Balerdi, Leire; Legarda, Almudena; Roldan, Montserrat; Letona, Laura; Munoz, Jose; Arribas, Jose R; Montejano Sanchez, Rocio; Diaz-Pollan, Beatriz; Stewart, Stefan Mark; Garcia, Irene; Borobia, Alberto; Estrada, Vicente; Cabello, Noemi; Nunez-Orantos, M J; Sagastagoitia, I; Homen, J R; Orviz, E; Horcajada, Juan P; Castaneda, Silvia; Sendra, Elena; Gomez-Junyent, Joan; Lopez-Montesinos, Inmaculada; Sanchez Montalva, Adrian; Espinosa-Pereiro, Juan; Bosch-Nicolau, Pau; Salvador, Fernando; Morales-Rull, Jose Luis; Pena, Anna Maria Moreno; Acosta, Cristina; Sole-Felip, Cristina; West, Emily; M'Rabeth-Bensalah, Khadija; Eichinger, Mareile L; Gruttner-Durmaz, Manuela; Grube, Christina; Zink, Veronika; Goes, Josefine; Tsertsvadze, Tengiz; Abutidze, Akaki; Chkhartishvili, Nikoloz; Metchurtchlishvili, Revaz; Endeladze, Marina; Paciorek, Marcin; Bursa, Dominik; Krogulec, Dominika; Pulik, Piotr; Ignatowska, Anna; Fishchuk, Roman; Kobrynska, Olena; Levandovska, Khrystyna; Kirieieva, Ivanna; Kuziuk, Mykhailo; Polizzotto, Mark; Carey, Catherine; Dharan, Nila J; Hough, Sally; Virachit, Sophie; Davidson, Sarah; Bice, Daniel J; Ognenovska, Katherine; Cabrera, Gesalit; Flynn, Ruth; Chia, Po Ying; Lee, Tau Hong; Lin, Ray J; Ong, Sean W X; Puah, Ser Hon; Yeo, Tsin Wen; Ongko, Juwinda; Yeo, He Ping; Kwaghe, Vivian; Zaiyad, Habib; Idoko, Godwin; Uche, Blessing; Selvamuthu, Poongulali; Kumarasamy, Nagalingeswaran; Beulah, Faith Ester; Govindarajan, Narayan; Mariyappan, Kowsalya; Abela, Cecilia; Moretto, Renzo; Belloc, Carlos G; Luduena, Jael; Amar, Josefina; Losso, Marcelo H; Toibaro, Javier; Macias, Laura Moreno; Fernandez, Lucia; Frare, Pablo S; Chaio, Sebastian R; Pachioli, Valeria; Timpano, Stella M; Sanchez, Marisa Del Lujan; De Paz Sierra, Mariana; Stanek, Vanina; Belloso, Waldo; Cilenti, Flavia L; Valentini, Ricardo N; Stryjewski, Martin E; Locatelli, Nicolas; Riera, Maria C Soler; Salgado, Clara; Baeck, Ines M; Di Castelnuovo, Valentina; Parmar, Mahesh K B; Goodman, Anna L; Gregory, Adam; Goodall, Katharine; Harris, Nicola; Wyncoll, James; Luntiel, A; Patterson, C; Morales, J; Witele, E; Preston, A M; Nandani, A; Price, D A; Nell, Jeremy; Patel, Bijal; Hays, Carole; Jones, Geraldine; Davidson, Jade; Pantazis, Nikos; Gioukari, Vicky; Souliou, Tania; Antoniadou, A; Kavatha, D; Grigoropoulou, S; Tziolos, R N; Oikonomopoulo, C; Moschopoulos, C; Tzimopoulos, K; Koromilias, A; Argyraki, K; Lourida, P; Bakakos, P; Vlachakos, V; Balis, E; Zakynthinos, S; Sigala, I; Gianniou, N; Dima, E; Magkouta, S; Synolaki, E; Konstanta, S; Vlachou, M; Stathopoulou, P; Panagopoulos, P; Petrakis, V; Papazoglou, D; Tompaidou, E; Isaakidou, E; Leontis, K; Nitsotolis, T; Athanasiou, K; Myrodia, M D; Kyriakoulis, K; Trontzas, I; Arfara-Melanini, M; Kolonia, V; Lukaakome, Joseph; Nsereko, Christoher; Lubega, Gloria; Kibirige, Moses; Nakahima, William; Wangi, Deus; Aguti, Evelyne; Generous, Lilian; Massa, Rosemary; Nalaki, Margaret; Magala, Felix; Nabaggala, Phiona Kaweesi; Kityo, Cissy; Mugerwa, Henry; Faith, Oryem Daizy; Florence, Apio; Emmanuel, Ocung; Beacham, Mugoonyi Paul; Geoffrey, Amone; Nakiboneka, Dridah; Apiyo, Paska; Kirenga, Bruce; Atukunda, Angella; Muttamba, Winters; Remmy, Kyeyume; Segawa, Ivan; Pheona, Nsubuga; Kigere, David; Mbabazi, Queen Lailah; Boersalino, Ledra; Nyakoolo, Grace; Fred, Aniongo; Alupo, Alice; Ebong, Doryn; Monday, Edson; Nalubwama, Ritah Norah; Kainja, Milton; Ambrose, Munu; Kwehayo, Vanon; Nalubega, Mary Grace; Ongoli, Augustine; Obbo, Stephen; Alaba, Jeniffer; Magombe, Geoffrey; Tino, Harriet; Obonya, Emmanuel; Kitonsa, Jonathan; Onyango, Martin; Naboth, Tukamwesiga; Naluyinda, Hadijah; Nanyunja, Regina; Irene, Muttiibwa; Jane, Biira; Wimfred, Kyobejja; Leonar, Ssemazzi; Deus, Tkiinomuhisha; Babra, Namasaba; Taire, Paul; Nabankema, Evelyn; Ogavu, Joseph; Mugerwa, Oscar; Okoth, Ivan; Mwebaze, Raymond; Mugabi, Timothy; Makhoba, Anthony; Arikiriza, Phiona; Theresa, Nabuuma; Nakayima, Hope; Frank, Kisuule; Ramgi, Patricia; Pereira, Kassia; Osinusi, Anu; Cao, Huyen; Stumpp, Michael; Goncalves, Susana; Ramanathan, Krishnan; Baseler, Beth; Holley, H Preston; Jankelevich, Shirley; Becker, Nancy; Dolney, Suzanne; Hissey, Debbie; Simpson, Shelly; Kim, Mi Ha; Beeler, Joy; Harmon, Liam; Asomah, Mabel; Jato, Yvonne; Stottlemyer, April; Tang, Olivia; Vanderpuye, Sharon; Yeon, Lindsey; Buehn, Molly; Eccard-Koons, Vanessa; Frary, Sadie; MacDonald, Leah; Cash, Jennifer; Hoopengardner, Lisa; Linton, Jessica; Schaffhauser, Marylu; Nelson, Michaela; Spinelli-Nadzam, Mary; Proffitt, Calvin; Lee, Christopher; Engel, Theresa; Fontaine, Laura; Osborne, C K; Hohn, Matt; Galcik, Michael; Thompson, DeeDee; Chang, Weizhong; Sherman, Brad T; Rupert, Adam W; Baseler, Michael; Lallemand, Perrine; Imamichi, Tom; Paudel, Sharada; Cook, Kyndal; Haupt, Kendra; Hazen, Allison; Badralmaa, Yunden; Smith, Kenneth; Patel, Bhakti; Kubernac, Robert; Hoover, Marie L; Brown, Craig; DuChateau, Nadine; Ellis, Sadie; Flosi, Adam; Fox, Lisa; Johnson, Les; Nelson, Rich; Stojanovic, Jelena; Treagus, Amy; Wenner, Christine; Williams, Richard

Affiliations

Abstract

Background: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection. Objective: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone. Design: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978) Setting: Multinational, multicenter trial. Participants: Adults hospitalized with COVID-19. Intervention: Intravenous ensovibep, 600 mg, or placebo. Measurements: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90. Results: An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n =247) or placebo (n =238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P= 0.68; OR> 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR> 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR< 1 would favor ensovibep). Limitation: The trial was prematurely stopped because of futility, limiting power for the primary outcome. Conclusion: Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified.

Keywords