Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19

著者: ACTIV-3/TICO Study Group*, Christina Barkauskas, Eleftherios Mylonakis, Garyfallia Poulakou, Barnaby Edward Young, David M. Vock, Lianne Siegel, Nicole Engen, Greg Grandits, Nilima Mosaly, Andrew M. Vekstein, Ralph Rogers, Fadi Shehadeh, Matthew Kaczynski, Evangelia K. Mylona, Konstantinos N. Syrigos, Vasiliki Rapti, David Chien Lye, Diong Shiau Hui, Lindsay Leither, Kirk U. Knowlton, Mamta K. Jain, Rubria Marines-Price, Alice Osuji, J. Scott Overcash, Ioannis Kalomenidis, Zafeiria Barmparessou, Michael R. Waters, Karla Zepeda, Peter Chen, Sam Torbati, Francis Kiweewa, Nicholus Sebudde, Eyad Almasri, Alyssa Hughes, Sanjay Bhagani, Alison Rodger, Uriel Sandkovsky, Robert Gottlieb, Nnakelu Eriobu, Barbara W. Trautner, Vidya Menon, Joseph Lutaakome, Michael Matthay, Philip A. Robinson, Konstantinos Protopapas, Nikolaos Koulouris, Ivan Kimuli, Amiran Baduashvili, Dominique L. Braun, Huldrych F. Günthard, Srikanth Ramachandruni, Robert Kidega, Kami Kim, Timothy Hatlen, Andrew Phillips, Daniel D. Murray, Tomas Ø. Jensen, María L. Padilla, Evan X. Accardi, Katy Shaw-Saliba, Robin Dewar, Marc Teitelbaum, Ven Natarajan, Sylvain Laverdure, Helene C. Highbarger, M. Tauseef Rehman, Susan Vogel, David Vallée, Page Crew, Negin Atri, Adam Schechner, Sarah Pett, Fleur Hudson, Jonathan Badrock, Giota Touloumi, Samuel M. Brown, Wesley H. Self, Crystal M. North, Adit A. Ginde, Christina C. Chang, Anthony D. Kelleher, Stephanie Nagy-Agren, Shikha Vasudeva, David P. Looney, Hien Nguyen, Adriana Sánchez, Amy Weintrob, Birgit Grund, Shweta Sharma, Cavan Reilly, Roger Paredes, Agnieszka Bednarska, Norman P. Gerry, Abdel G. Babiker, Victoria J. Davey, Annetine C. Gelijns, Elizabeth S. Higgs, Virginia Kan, Gail Matthews, B. Taylor Thompson, Philippe Legenne, Richa Chandra, H. Clifford Lane, James D. Neaton, Jens Lundgren, Christina Barkauskas, Eleftherios Mylonakis, Garyfallia Poulakou, Barnaby Edward Young, David M. Vock, Lianne Siegel, Nicole Engen, Greg Grandits, Nilima Mosaly, Andrew M. Vekstein, Ralph Rogers, Fadi Shehadeh, Matthew Kaczynski, Evangelia K. Mylona, Konstantinos N. Syrigos, Vasiliki Rapti, David Chien Lye, Diong Shiau Hui, Lindsay Leither, Kirk U. Knowlton, Mamta K. Jain, Rubria Marines-Price, Alice Osuji, J. Scott Overcash, Ioannis Kalomenidis, Zafeiria Barmparessou, Michael R. Waters, Karla Zepeda, Peter Chen, Sam Torbati, Francis Kiweewa, Nicholus Sebudde, Eyad Almasri, Alyssa Hughes, Sanjay Bhagani, Alison Rodger, Uriel Sandkovsky, Robert Gottlieb, Nnakelu Eriobu, Barbara W. Trautner, Vidya Menon, Joseph Lutaakome, Michael Matthay, Philip A. Robinson, Konstantinos Protopapas, Nikolaos Koulouris, Ivan Kimuli, Amiran Baduashvili, Dominique L. Braun, Huldrych F. Günthard, Srikanth Ramachandruni, Robert Kidega, Kami Kim, Timothy Hatlen, Andrew Phillips, Daniel D. Murray, Tomas Ø. Jensen, María L. Padilla, Evan X. Accardi, Katy Shaw-Saliba, Robin Dewar, Marc Teitelbaum, Ven Natarajan, Sylvain Laverdure, Helene C. Highbarger, M. Tauseef Rehman, Susan Vogel, David Vallée, Page Crew, Negin Atri, Adam Schechner, Sarah Pett, Fleur Hudson, Jonathan Badrock, Giota Touloumi, Samuel M. Brown, Wesley H. Self, Crystal M. North, Adit A. Ginde, Christina C. Chang, Anthony D. Kelleher, Stephanie Nagy-Agren, Shikha Vasudeva, David P. Looney, Hien Nguyen, Adriana Sánchez, Amy Weintrob, Birgit Grund, Shweta Sharma, Cavan Reilly, Roger Paredes, Agnieszka Bednarska, Norman P. Gerry, Abdel G. Babiker, Victoria J. Davey, Annetine C. Gelijns, Elizabeth S. Higgs, Virginia Kan, Gail Matthews, B. Taylor Thompson, Philippe Legenne, Richa Chandra, H. Clifford Lane, James D. Neaton, Jens Lundgren, David Sahner, J.W. Tierney, Betsey Herpin, Mary Smolskis, Laura A McKay, Kelly Cahill, Ratna Sardana, Sharon Segal Raim, Lisa Hensely, Joshua Lorenzo, Rebecca Mock, Judith Zuckerman, Mark D. Miller, Lucy Chung, Nayon Kang, Stacey J. Adam, Sarah Read, Ruxandra Draghia‐Akli, Amy Carlsen, Anita Carter, Eileen Denning, Alain DuChêne, Kate Eckroth, Alex Frase, Greg Gandits, Merrie Harrison, Payton Kaiser, Joseph S. Koopmeiners, Sue Meger, Thomas A. Murray, Kien Quan, Siu Fun Quan, Greg Thompson, Jamie Walski, Deborah Wentworth, Alan J. Moskowitz, Emilia Bagiella, Ellen Moquete, Karen O’Sullivan, Mary E. Marks, Emily Kinzel, Sarah Burris, Gabriela Bedoya, Lola Gupta, Jessica Overbey, Maria L. Padillia, Milerva Santos, Marc A. Gillinov, Marissa A. Miller, Wendy C. Taddei‐Peters, Kathleen N. Fenton, M. Mack, Mezgebe Berhe, Clinton Haley, Emma Dishner, Christopher Bettacchi, Kevin Golden, Erin Duhaime, Madison Ryan, Sarah Burris, Catherine Tallmadge, Lorie Estrada, Felecia Jones, Samatha Villa, Samatha Wang, Raven Robert, Tanquinisha Coleman, Laura Clariday, Rebecca Baker, Mariana Hurutado-Rodriguez, Nazia Iram, Michelle Fresnedo, Allyson Davis, Kiara Leonard, Noelia Ramierez, Jon Thammavong, Krizia Duque, Emma Turner, T. L. Fisher, Dianna Robinson, Desirae Ransom, Nicholas Maldonado, Erica Lusk, Aaron Killian, Adriana Palacious, Edilia Solis, Janet Jerrow, Matthew Watts, Heather Whitacre, Elizabeth Cothran, Peter K. Smith, Emily R. Ko, Grace R. Dreyer, Neil Stafford, Megan Brooks, Tatyana Der, Marie Witte, Ruwan Gamarallage, John Franzone, Noel Ivey, Rebecca Lumsden, Ahmaad Mourad, Thomas L Holland, Mary Motta, Kathleen Lane, Lauren M. McGowan, Jennifer Stout, Heather Aloor, Kennesha M. Bragg, Barvina Toledo, Beth McLendon-Arvik, Barbara Bussadori, Beth Hollister, Michelle Griffin, Dana M. Giangiacomo, Vicente Martínez Rodríguez, Patrick E. Parrino, Stephen M. Spindel, Aditya Bansal, Katherine Baumgarten, Johnathan Hand, Derek J. Vonderhaar, Bobby D. Nossaman, Sylvia Laudun, DeAnna Ames, Shane Broussard, Nilmo Hernandez, Geralyn Isaac, Huan Dinh, Yiling Zheng, Sonny Tran, Hunter McDaniel, Nicolle Crovetto, Emerson C. Perin, Briana Costello, Prasad Manian, M. Rizwan Sohail, Alexander Postalian, Punit Hinsu, Carolyn Watson, James Chen, Melyssa Fink, Lydia Sturgis, Walker Kim, Kim Mahon, Jennifer Parenti, Casey Kappenman, Aryn Knight, Jeffrey M. Sturek, Andrew Barros, Kyle B. Enfield, Alexandra Kadl, China J. Green, Rachel M. Simon, Ashley Fox, Kara J Thornton, Amy Adams, Jay H. Traverse, Frank S. Rhame, Joshua Huelster, Rajesh Kethireddy, Julianne Salamanca, Christine Majeski, Paige Skelton, Maria Zarambo, Andrea Sarafolean, Cathryn F. Oldmixon, Nancy Ringwood, Ariela Muzikansky, Richard P. Morse, Roy G. Brower, Lora A. Reineck, Neil R. Aggarwal, Karen Bienstock, Jay Steingrub, Peter Hou, Jay S. Steingrub, Mark Tidswell, Lori-Ann Kozikowski, Cynthia Kardos, Leslie DeSouza, Sarah Romain, Daniel Talmor, Nathan I. Shapiro, Konstantinos Andromidas, Valerie Banner‐Goodspeed, Michael Bolstad, Katherine L. Boyle, Payton Cabrera, Arnaldo deVilla, Joshua C. Ellis, Ana Grafals, Sharon Hayes, Conor Higgins, Lisa Kurt, Nicholas Kurtzman, Kimberly Redman, Elinita Rosseto, Douglas Scaffidi, Nathan I. Shapiro, Daniel Talmor, Michael R. Filbin, Kathryn A. Hibbert, Blair A. Parry, Justin Margolin, Brooklynn Hillis, Rhonda Hamer, Alan E. Jones, James Galbraith, Utsav Nandi, Gregory Hendey, Michael A. Matthay, Kirsten N. Kangelaris, Kimia Ashktorab, Rachel Gropper, Anika Agrawal, Eyad Almasri, Mohamed Fayed, Kinsley Hubel, Rebekah L. Garcia, George Lim, Steven Y. Chang, Gregory Hendey, Michael Lin, Julia Vargas, Hena Sihota, Rebecca M. Beutler, Angela J. Rogers, Jennifer G. Wilson, Rosemary Vojnik, Cynthia Pérez, Jordan H. McDowell, Timothy E. Albertson, Erin Hardy, Richart W. Harper, M.A. Moss, Adit A. Ginde, Lakshmi Chauhan, David J. Douin, Flora Martinez, Lani Finck, Jill Bastman, Robert C. Hyzy, Pauline K. Park, Robert C. Hyzy, Pauline K. Park, Kristine Nelson, J.I. Mcsparron, Ivan Co, Bonnie R. Wang, José Jimenez, Barbara Sullins, Norman Olbrich, Michelle N. Gong, Lynne D. Richardson, Michelle N. Gong, Rahul Nair, Brenda López, Omowunmi Amosu, Hiwet Tzehaie, William Nkemdirim, Sabah Boujid, Jarrod Mosier, Cameron Hypes, Elizabeth Salvagio Campbell, Billie Bixby, Boris Gilson, Anitza Lopez, R. Duncan Hite, Thomas E. Terndrup, Herbert Wiedemann, Kristin Hudock, Hammad Tanzeem, Harshada More, Jamie Martinkovic, Susan Sellers, Judy Houston, Mary Burns, Catherine L. Hough, Bryce H. Robinson, Catherine L. Hough, Akram Khan, Olivia Krol, Emmanuel Mills, Mistry Kinjal, Genesis Briceño, Raju Reddy, Kinsley Hubel, Tanyalak Parimon, Antonina Caudill, Brittany Mattison, Susan Jackman, Po-En Chen, Emad Bayoumi, Cristabelle Ojukwu, Devin Fine, Gwendolyn Weissberg, Katherine Isip, Yunhee Choi-Kuaea, Shaunt Mehdikhani, Tahir B. Dar, Nsole Biteghe Fleury Augustin, Dana Tran, Jennifer Dukov, D. Shane O’Mahony, David M. Wilson, Julie A. Wallick, Alexandria M. Duven, Dakota D. Fletcher, D. Clark Files, Chadwick Miller, Kevin W. Gibbs, Lori Flores, Mary LaRose, Leigha Landreth, D. Rafael Palacios, Lisa Parks, Madeline Hicks, Andrew Goodwin, Edward F. Kilb, Caitlan Lematty, Kerilyn Patti, Joseph Bledsoe, Samuel M. Brown, Michael J. Lanspa, Ithan Pelton, Brent Armbruster, Quinn Montgomery, Naresh Kumar, Melissa Fergus, Karah Imel, Ghazal Palmer, Brandon Webb, Carolyn Klippel, Hannah Jensen, Sarah Duckworth, Andrew Gray, Tyler Burke, Dan Knox, Jenna Lumpkin, Valerie Aston, Todd W. Rice, Wesley H. Self, Todd W. Rice, Jonathan D. Casey, Jakea Johnson, Margaret Hays, Moiz Kasubhai, Anjana Pillai, Jean Daniel, Daniel Sittler, Balavenkatesh Kanna, Nargis Jilani, Francisco Amaro, Jessica Santana, Aleksandr Lyakovestsky, Issa Madhoun, Louis Marie Desroches, Nicole Amadon, Alaa Bahr, Imaan Ezzat, Maryanne Guerrero, Joane Padilla, Jessie Fullmer, Inderpreet Singh, Syed Shah, Rajeev Narang, Polly Mock, Melissa Shadle, Brenda Y. Hernandez, Kevin D. Welch, Andrea Payne, Gabriela Ertl, Daniel Canario, Isabel Barrientos, Danielle Goss, Mattie DeVries, Ibidolapo Folowosele, Dorothy Garner, Mariana Gómez, Justin Price, Ekta Bansal, Jim Wong, Jason Faulhaber, Tasaduq Fazili, Brian Yeary, Ruth Ndolo, Christina Bryant, Bridgette Smigeil, Rana Najjar, Patrice Jones, Julie Nguyen, Christina Chin, Hassan Taha, Salah Najm, Chris Smith, Jason H. Moore, Talal Nassar, Nick Gallinger, Amy Christian, D’Amber Mauer, Ashley Phipps, Jordan Coslet, Rosalynn Landazuri, Jacob Pineda, Nicole Uribe, Jose Ruiz Garcia, Cecilia Barbabosa, Kaitlyn Sandler, Adrienna Marquez, Hanh Chu, Kia Lee, Kimberly Quillin, Andrea Arnaiz García, Pauline Lew, Quynh-Lam Tran, Gregorio Benitez, Biswajit Mishra, Lewis Oscar Felix, Maria Tsikala Vafea, Eleftheria Atalla, Robin Davies, Salma Hedili, Maria Andrea Monkeberg, Sandra Tabler, Eleftherios Mylonakis, Ralph Rogers, Fadi Shehadeh, Evangelia K. Mylona, Matthew Kaczynski, Quynh-Lam Tran, Gregorio Benitez, Biswajit Mishra, Lewis Oscar Felix, Maria Tsikala Vafea, Eleftheria Atalla, Robin Davies, Salma Hedili, Britt Harrington, L. Popielski, Amy Kambo, Kimberley Viens, Melissa Turner, Michael J. Vjecha, Alice Osuji, Barbine Tchamba Agbor Agbor, Tianna Petersen, Dena Kamel, Laura Hansen, Angie Garcia, Christine Cha, Azadeh Mozaffari, Rosa Marı́a Hernández, Mamta K. Jain, Barbine Tchamba Agbor Agbor, Tianna Petersen, Dena Kamel, Laura Hansen, Angie Garcia, Mi‐Na Kim, Natalie DellaValle, S. Jake Gonzales, Charurut Somboonwit, Asa Oxner, Lucy Guerra, Thanh Tran, Avenette Pinto, Betty Lise Anderson, Ana Zepeda-Gutierrez, Dannae Martin, Cindi Temblador, Avon Cuenca, Mario Guerrero, Eric S. Daar, Ramiro Correa, Gabe Hartnell, Glenn Wortmann, Saumil Doshi, Theresa Moriarty, Melissa Gonzales, Kristin Garman, Jason V. Baker, Anne Frosch, R. Jeffrey Goldsmith, Hodan Jibrell, Melanie Lo, Jonathan Klaphake, Shari Mackedanz, Linh Ngo, Kelly Garcia-Myers, Ken M. Kunisaki, Miranda Hassler, Mary Walquist, Michael Augenbraun, Jack DeHovitz, Mahsa Abassi, Anne‐Marie Leuck, Via Rao, Kousick Biswas, Cristin Harrington, Amanda Núñez García, Tammy Bremer, T. R. JUN. BURKE, Brittany Koker, Anne Davis‐Karim, David W. Pittman, Shikha Vasudeva, Lavannya M. Pandit, Casey Hines‐Munson, John Van, Laura W. Dillon, Yiqun Wang, Tracy Ochalek, Erin Caldwell, Edward Humerickhouse, David Boone, William McGraw, Sanjay R. Mehta, Scott Johns, Melissa St. John, Jacqueline Raceles, Emily Sear, Stephen Funk, Rosa Cesarini, Michelle Fang, Keith Nicalo, Wonder Drake, Beatrice Jones, Teresa Holtman, Archana Maniar, Eric A. Johnson, Lam Nguyen, Michelle Tran, Thomas Barrett, Tera Johnston, John T. Huggins, Tatsiana Y. Beiko, Heather Hughes, William C. McManigle, Nichole T. Tanner, Ronald G. Washburn, Magdalena Ardelt, Patricia A. Tuohy, Jennifer L. Mixson, Charles G. Hinton, Nicola Thornley, Heather K. Allen, Shannon Elam, Barry Boatman, Brittany J. Baber, Rudell Ryant, Brentin Roller, Chinh Nguyen, Amani Morgan Mikail, Marivic Hansen, Paola Lichtenberger, Gio Baracco, Carol Ramos, Lauren Bjork, Melyssa Sueiro, Phyllis C. Tien, Heather Freasier, Theresa Buck, Hafida Nekach, Mark Holodniy, Aarthi Chary, Kan Lu, Theresa Peters, Jéssica López, Susanna Tan, R. Lee, Aliya Asghar, Tasadduq Karim Karyn Isip, Katherine Le, Thao D. Nguyen, Shinn Wong, Dorthe Raben, Bitten Aagaard, Charlotte B. Nielsen, Katharina Krapp, Bente Rosdahl Nykjær, Christina Olsson, Katja Lisa Kanne, Anne Louise Grevsen, Zillah Maria Joensen, Tina Bruun, Ane Bojesen, Frederik Woldbye, Nick E. Normand, Thomas Benfield, Clara Lundetoft Clausen, Nichlas Hovmand, Simone Bastrup Israelsen, Katrine Kjær Iversen, Cæcilie Leding, Karen Brorup Pedersen, Louise Thorlacius-Ussing, Michaela Tinggaard, Sandra Tingsgård, Jens‐Ulrik Stæhr Jensen, Rikke Overgaard, Ema Rastoder, Christian Kjer Heerfordt, Caroline Hedsund, Christian Phillip Ronn, Peter Kamstrup, Dorthe Sandbæk Høgsberg, Christina Marisa Bergsøe, Lars Østergaard, Nina Breinholt Stærke, Yordanos Yehdego, Ane Sondergaard, Işık Somuncu Johansen, Inge K. Holden, Susan Olaf Lindvig, Marie Helleberg, Jan Gerstoft, Ole Kirk, Tina Bruun, Tomas Ø. Jensen, Birgitte Lindegaard Madsen, Thomas Ingemann Pedersen, Zitta Barrella Harboe, Birgit Thorup Røge, Thomas Michael Hansen, Matilde Kanstrup Glesner, Sandra Valborg Løfberg, Ariella Denize Nielsen, Henrik Nielsen, Rikke Krog Thisted, Kristine Toft Petersen, Maria Ruwald Juhl, Daria Podlekareva, Stine Johnsen, Lothar Wiese, Lene Surland Knudsen, Maria Expósito, José Badillo, Ana Martínez, Elena Abad, Ana Chamorro, Lourdes Mateu, Sergio España, Maria Constanza Lucero, José Ramón Santos, Gemma Lladós, Cristina Lopez, Lydia Carabias, Eduardo Fernández‐Cruz, Marisa Di Natale, Sergiu Padure, Jimena Gomez, Cristina Ausín, Eva Cervilla, Héctor Balastegui, Carmen Rodríguez Sáinz, Paco Lopez, Mariam Escobar, Leire Balerdi, Almudena Legarda, Montserrat Roldán, Laura Letona, José Muñóz, José Ramón Arribas, Rocio Montejano Sánchez, Beatriz Díaz‐Pollán, Stefan Stewart, Irene García-García, Alberto M. Borobia, Vicente Estrada, Noemí Cabello, M.J. Nuñez-Orantos, Íñigo Sagastagoitia, J.R. Homen, Eva Orviz, Adrián Sánchez Montalvá, Juan Espinosa‐Pereiro, Pau Bosch‐Nicolau, Fernando Salvador, José Luís Morales‐Rull, Anna Maria Moreno Pena, Cristina Acosta, Cristina Solé-Felip, Emily West, Khadija M’Rabeth-Bensalah, Mareile L. Eichinger, Manuela Grüttner-Durmaz, Christina Grube, Veronika Zink, Josefine Goes, Tengiz Tsertsvadze, Akaki Abutidze, Nikoloz Chkhartishvili, Revaz Metchurtchlishvili, Marina Endeladze, Marcin Paciorek, Dominik Bursa, Dominika Krogulec, Piotr Pulik, Anna Ignatowska, Roman Fishchuk, Olena Kobrynska, Khrystyna Levandovska, Ivanna Kirieieva, Mykhailo Kuziuk, Mark N. Polizzotto, Catherine L. Carey, Nila J. Dharan, Sally Hough, Sophie Virachit, Sarah Davidson, Daniel J. Bice, Katherine Ognenovska, Gesalit Cabrera, Ruth Flynn, Po Ying Chia, Tau Hong Lee, Ray J. Lin, Sean Wei Xiang Ong, Ser Hon Puah, Tsin Wen Yeo, Juwinda Ongko, He Ping Yeo, Vivian Kwaghe, Habib Zaiyad, Godwin Idoko, Blessing Uche, Poongulali Selvamuthu, Nagalingeswaran Kumarasamy, Faith Ester Beulah, Narayan Govindarajan, Kowsalya Mariyappan, Marcelo H. Losso, Cecilia Abela, Renzo Moretto, Carlos G. Belloc, Jael Ludueña, Josefina Amar, Marcelo H. Losso, Javier Toibaro, Laura Moreno Macias, Lucia Fernandez, Pablo S. Frare, Sebastián Chaio, Valeria Pachioli, Stella M. Timpano, Marisa del Lujan Sanchez, Mariana de Paz Sierra, Vanina Stanek, Waldo Belloso, Flavia L. Cilenti, Ricardo Valentini, Martín E. Stryjewski, Nicolas Locatelli, Maria C. Soler Riera, Clara Salgado, Inés Baeck, Valentina Di Castelnuovo, Stella M. Zarza, Mahesh Parmar, Anna L. Goodman, Adam Gregory, Katharine J. Goodall, Nicola Harris, James Wyncoll, A. Luntiel, Caroline Patterson, José María López Morales, Eric Witele, A.M. Preston, Aarti Nandani, David Price, Jeremy Nell, Bijal Patel, Carole Hays, Geraldine Jones, Jade Davidson, Nikos Pantazis, Vicky Gioukari, Tania Souliou, Anastasia Antoniadou, Dimitra Kavatha, Sotiria Grigoropoulou, Nikolaos Tziolos, C. Oikonomopoulo, Charalampos D. Moschopoulos, Kostas Tzimopoulos, Athanasios Koromilias, Katerina Argyraki, Panagiota Lourida, Petros Bakakos, Vasileios Vlachakos, Evangelos Balis, Spyros Zakynthinos, Ioanna Sigala, N. Gianniou, Efrossini Dima, Sophia Magkouta, E. Synolaki, S. Konstanta, Margarita Vlachou, Panagiota Stathopoulou, Periklis Panagopoulos, Vasileios Petrakis, Dimitrios Papazoglou, E. Tompaidou, E. Isaakidou, Konstantinos Leontis, Thomas Nitsotolis, Kalomoira Athanasiou, M.D. Myrodia, Konstantinos G. Kyriakoulis, Ioannis P. Trontzas, M. Arfara-Melanini, V. Kolonia, Cissy Kityo, Henry Mugerwa, Joseph Lukaakome, Christoher Nsereko, Gloria Lubega, Moses Kibirige, William Nakahima, Deus Wangi, Evelyne Aguti, Lilian Generous, Rosemary Massa, Margaret Nalaki, Felix Magala, Phiona Kaweesi Nabaggala, Cissy Kityo, Henry Mugerwa, Oryem Daizy Faith, Apio Florence, Ocung Emmanuel, Mugoonyi Paul Beacham, Amone Geoffrey, Dridah Nakiboneka, Paska Apiyo, Francis Kiweewa, Bruce Kirenga, Ivan Kimuli, Angella Atukunda, Winters Muttamba, Kyeyume Remmy, Ivan Segawa, Nsubuga Pheona, David Kigere, Queen Lailah Mbabazi, Ledra Boersalino, Grace Nyakoolo, Francis Kiweewa, Aniongo Fred, Alice Alupo, Doryn Ebong, Edson Monday, Ritah Norah Nalubwama, Milton Kainja, Munu Ambrose, Vanon Kwehayo, Mary Grace Nalubega, Augustine Ongoli, Stephen Obbo, Jeniffer Alaba, Geoffrey Magombe, Harriet Tino, Emmanuel Obonya, Joseph Lutaakome, Jonathan Kitonsa, Martin Onyango, Tukamwesiga Naboth, Hadijah Naluyinda, Regina Nanyunja, Muttiibwa Irene, Biira Jane, Kyobejja Wimfred, Ssemazzi Leonar, Tkiinomuhisha Deus, Namasaba Babra, Paul Taire, Joseph Lutaakone, Evelyn Nabankema, Joseph Ogavu, Oscar Mugerwa, Ivan Okoth, Raymond Mwebaze, Timothy Mugabi, Anthony Makhoba, Phiona Arikiriza, Nabuuma Theresa, Hope Nakayima, Kisuule Frank, Patrícia Ramgi, Kássia Pereira, Anu Osinusi, Huyen Cao, Michael T. Stumpp, Susana Gonçalves, Krishnan Ramanathan, Beth Baseler, H. Preston Holley, Shirley Jankelevich, Amy Adams, Nancy Becker, Suzanne Dolney, Debbie Hissey, Shelly Simpson, Mi Ha Kim, Joy Beeler, Liam Harmon, Mabel Asomah, Yvonne Jato, April Stottlemyer, Olivia Tang, Sharon Vanderpuye, Lindsey Yeon, Molly Buehn, Vanessa Eccard-Koons, Sadie Frary, Leah MacDonald, Jennifer Cash, Lisa Hoopengardner, Jessica Linton, Marylu Schaffhauser, Michaela Nelson, Mary Spinelli-Nadzam, Calvin Proffitt, Christopher S. Lee, Theresa Engel, Laura Fontaine, Cody Osborne, Matt Hohn, Michael Galcik, DeeDee Thompson, Weizhong Chang, Brad T. Sherman, Adam Rupert, Michael Baseler, Perrine Lallemand, Tomozumi Imamichi, Sharada Paudel, Kyndal Cook, Kendra Haupt, Jeroen Highbarger, Allison Hazen, Yunden Badralmaa, Kenneth E. Smith, Bhakti Patel, Robert Kubernac, Marie L. Hoover, Craig Brown, Nadine DuChateau, Sadie Ellis, Adam Flosi, Lisa Fox, Les Johnson, Rich Nelson, Jelena Stojanović, Amy Treagus, Christine Wenner, Richard Williams - Annals of Internal Medicine 2022 被引用: 31

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: = 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. PRIMARY FUNDING SOURCE: National Institutes of Health.