Annals of Internal Medicine, volume 175, issue 9, pages 1266-1274
Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19
Christina Barkauskas
1
,
Garyfallia Poulakou
2
,
Barnaby E Young
3
,
David M. Vock
4
,
Lianne Siegel
4
,
Nicole Engen
4
,
Greg Grandits
4
,
Nilima R Mosaly
5
,
Andrew M. Vekstein
5
,
Konstantinos N Syrigos
2
,
Vasiliki Rapti
2
,
David C Lye
6
,
Diong Shiau Hui
7
,
Lindsay Leither
8
,
Kirk U. Knowlton
9
,
Rubria Marines-Price
10
,
J. Scott Overcash
11
,
Ioannis Kalomenidis
12
,
Zafeiria Barmparessou
12
,
Michael Waters
13
,
Karla Zepeda
13
,
Peter Chen
14
,
Sam Torbati
14
,
Nicholus Sebudde
15
,
Alyssa Hughes
16
,
Sanjay R Bhagani
17
,
Alison Rodger
17
,
Uriel Sandkovsky
18
,
Robert L. Gottlieb
18
,
Eriobu Nnakelu
19
,
Barbara Trautner
20
,
Vidya Menon
21
,
Michael Matthay
22
,
Philip Robinson
23
,
Konstantinos Protopapas
24
,
Nikolaos Koulouris
25
,
Amiran Baduashvili
26
,
Dominique L. Braun
27
,
Huldrych F. Günthard
28
,
Srikanth Ramachandruni
29
,
Robert Kidega
30
,
Kami Kim
31
,
Timothy J. Hatlen
32
,
Andrew N. Phillips
33
,
Daniel D. Murray
34
,
Tomas O Jensen
35
,
Maria L. Padilla
36
,
Evan X Accardi
36
,
Katy Shaw Saliba
37
,
Robin L. Dewar
38
,
Marc Teitelbaum
39
,
Ven Natarajan
38
,
Sylvain Laverdure
40
,
Helene C. Highbarger
38
,
M Tauseef Rehman
38
,
Susan Vogel
41
,
David Vallée
42
,
Page Crew
43
,
Negin Atri
41
,
Adam J Schechner
39
,
Sarah Pett
44
,
Fleur Hudson
44
,
Jonathan Badrock
44
,
Giota Touloumi
45
,
Samuel M. Brown
46
,
Crystal M. North
47
,
Christina C. Chang
48
,
Anthony Kelleher
48
,
Stephanie Nagy-Agren
49
,
Shikha Vasudeva
49
,
David Looney
50
,
Hien H Nguyen
51
,
Adriana Sánchez
52
,
Amy C Weintrob
53
,
Birgit Grund
54
,
Shweta Sharma
4
,
Cavan S. Reilly
4
,
Roger Paredes
55
,
Agnieszka Bednarska
56
,
Norman P Gerry
57
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Abdel G. Babiker
44
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Victoria J. Davey
58
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Annetine C. Gelijns
59
,
Elizabeth S. Higgs
37
,
Virginia Kan
60
,
Gail Matthews
48
,
B. Taylor Thompson
47
,
Philippe Legenne
61
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Richa Chandra
62
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H. Clifford Lane
37
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James D. Neaton
4
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Jens D. Lundgren
34
,
David Sahner
63
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John Tierney
63
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Betsey R. Herpin
63
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Mary C Smolskis
63
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Laura A Mckay
63
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Kelly Cahill
63
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Ratna Sardana
63
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Sharon Segal Raim
63
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Lisa Hensely
63
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Joshua Lorenzo
63
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Rebecca Mock
63
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Judith Zuckerman
63
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Mark Miller”
63
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Lucy Chung
63
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Nayon Kang
63
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Stacey J. Adam
64
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Sarah Read
64
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Ruxandra Draghia-Akli
64
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Amy Carlsen
65
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Anita Carter
65
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Eileen Denning
65
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Alain Duchene
65
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Kate Eckroth
65
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Alex Frase
65
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Greg Gandits
65
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Merrie Harrison
65
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Payton Kaiser
65
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Joseph Koopmeiners
65
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Sue Meger
65
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Thomas Murray
65
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Kien Quan
65
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Siu Fun Quan
65
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Greg Thompson
65
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Jamie Walski
65
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Deborah Wentworth
65
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Alan J. Moskowitz
66
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Emilia Bagiella
66
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Ellen Moquete
66
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Karen O’Sullivan
66
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Mary E. Marks
66
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Emily Kinzel
66
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Gabriela Bedoya
66
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Lola Gupta
66
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Jessica R. Overbey
66
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Maria L Padillia
66
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Milerva Santos
66
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Marc A. Gillinov
67
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Marissa A. Miller
68
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Wendy C. Taddei-Peters
68
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Kathleen Fenton
68
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Michael Mack
69
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Mezgebe Berhe
69
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Clinton Haley
69
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Emma Dishner
69
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Christopher Bettacchi
69
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Kevin Golden
69
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Erin Duhaime
69
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Madison Ryan
69
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Sarah Burris
69
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Catherine Tallmadge
69
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Lorie Estrada
69
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Felecia Jones
69
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Samatha Villa
69
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Samatha Wang
69
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ROBERT RAVEN
69
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Tanquinisha Coleman
69
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Laura Clariday
69
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Rebecca Baker
69
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Mariana Hurutado Rodriguez
69
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Nazia Iram
69
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Michelle Fresnedo
69
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Allyson Davis
69
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Kiara Leonard
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Noelia Ramierez
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Jon Thammavong
69
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Krizia Duque
69
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Emma Turner
69
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Tammy Fisher
69
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Dianna Robinson
69
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Desirae Ransom
69
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Nicholas Maldonado
69
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Erica Lusk
69
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Aaron Killian
69
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Adriana Palacious
69
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Edilia Solis
69
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Janet Jerrow
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Matthew Watts
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Heather Whitacre
69
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Elizabeth Cothran
69
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Peter K. Smith
70
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Emily R. Ko
70
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Grace R Dreyer
70
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Neil Stafford
70
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Megan Brooks
70
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Tatyana Der
70
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Marie Witte
70
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Ruwan Gamarallage
70
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John Franzone
70
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70
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Rebecca H Lumsden
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Ahmaad Mourad
70
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Thomas L Holland
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Mary Motta
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Michelle Griffin
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72
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Deanna Ames
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Nilmo Hernandez
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Huan Dinh
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Yiling Zheng
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Emerson Perin
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Alexander Postalian
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Carolyn Watson
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73
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Lydia Sturgis
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75
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76
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Nancy Ringwood
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78
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79
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Jessie Fullmer
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INDERPREET SINGH
107
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Syed Hamad Ali Shah
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Rajeev Narang
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Polly Mock
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Melissa Shadle
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Brenda Hernandez
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Pauline Lew
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Maria Andrea Monkeberg
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RALPH ROGERS
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KAN LU
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Nikos Pantazis
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Vicky Gioukari
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191
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1
Division of Pulmonary, Allergy, and Critical Care, Department of Medicine, Duke Health, Durham, North Carolina
|
3
National Centre for Infectious Diseases, Singapore
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4
6
National Centre for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, Singapore
|
7
National Centre for Infectious Diseases, Tan Tock Seng Hospital, Singapore
|
8
Division of Pulmonary and Critical Care, Department of Medicine, Intermountain Medical Center, Salt Lake City, Utah
|
9
Cardiovascular Department, Intermountain Medical Center, Salt Lake City, Utah
|
11
Velocity San Diego, San Diego, California
|
13
Velocity Chula Vista, San Diego, California
|
14
Cedars-Sinai Medical Center, Los Angeles, California
|
15
Lira Regional Referral Hospital, Lira, Uganda
|
17
Royal Free Hospital, London, England
|
18
Baylor Scott & White Health, Dallas, Texas
|
19
Institute of Human Virology Nigeria, Abuja, Nigeria
|
20
21
NYC Health + Hospitals/Lincoln, Bronx, New York
|
23
Hoag Memorial Hospital Presbyterian, Newport Beach, California
|
26
29
CHRISTUS Spohn Shoreline Hospital, Corpus Christi, Texas
|
30
Gulu Regional Referral Hospital, Gulu, Uganda
|
32
Lundquist Institute for Biomedical Innovation, Torrance, California
|
34
CHIP Center of Excellence for Health, Immunity, and Infections and Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
|
39
Leidos Biomedical Research, Frederick, Maryland
|
40
Laboratory of Human Retrovirology and Immunoinformatics, National Institutes of Health, Frederick, Maryland
|
41
Office of Clinical Research Policy and Regulatory Operations, National Institutes of Health, Bethesda, Maryland
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43
Collaborative Clinical Research Branch, National Institutes of Health, Bethesda, Maryland
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44
47
49
Salem Veterans Affairs Medical Center, Salem, Virginia
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50
The Veterans Medical Research Foundation, San Diego, California
|
51
Veterans Affairs Northern California Health Care System, Sacramento, California
|
52
Washington Veterans Affairs Medical Center, Washington, DC
|
53
Infectious Diseases Section, Washington Veterans Affairs Medical Center, Washington, DC
|
55
Hospital Universitari Germans Trias I Pujol, Badalona, Spain
|
57
Advanced BioMedical Laboratories, Cinnaminson, New Jersey
|
58
U.S. Department of Veterans Affairs, Washington, DC
|
60
Infectious Diseases Section, Veterans Affairs Medical Center, Washington, DC
|
61
Molecular Partners, Zurich, Switzerland
|
62
Novartis, East Hanover Township, New Jersey
|
64
Foundation for the National Institutes of Health, The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) and Operation Warp Speed
69
Baylor Scott & White Health
71
Lutheran Medical Group
72
Ochsner Clinic
73
Texas Heart Institute
|
74
University of Virginia Health Systems
|
75
Minneapolis Heart Institute Foundation
|
78
ALIGNE Site Coordinating Center (SCC) Lead Investigators, Baystate Medical Center
|
80
Baystate Medical Center
81
Beth Israel Deaconess Medical Center
83
University Of Mississippi
|
85
University of California Fresno
|
92
Mount Sinai hospital
93
Montefiore Medical Center Moses
94
Banner University Medical Center Tucson
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101
Cedars-Sinai Medical Center
102
Swedish Hospital First Hill
103
Wake Forest Baptist Health
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104
Medical Center of South Carolina
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105
Intermountain Medical Center
107
Lincoln Medical center
108
CHRISTUS Spohn Shoreline Hospital
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109
Hendrick Medical Center
110
Carilion Roanoke Memorial Hospital
|
111
Hoag Memorial Hospital Presbyterian
112
Cotton O’Neil Clinical Research Center
113
Velocity Chula Vista
|
114
Velocity San Diego
|
116
The Miriam Hospital
117
INSIGHT Washington ICC, Veterans Affairs (VA) Medical Center, Washington, DC
|
118
Parkland Health and Hospital Systems
121
Lundquist Institute for Biomedical Innovation
122
MedStar Health Research Institute
123
Hennepin Healthcare Research Institute, Minneapolis, Minnesota
|
124
Minneapolis VA Medical Center
|
125
SUNY DownState Medical Center
127
INSIGHT US Department of Veterans Affairs (VA) ICC
128
Michael E. DeBakey VA Medical Center, Houston, Texas
|
129
Salem VA Medical Center, Salem, Virginia
|
130
VA San Diego Healthcare System
|
131
VA TVHS Nashville Campus
|
133
Portland VA Health Care System
134
Charles VA Medical Center
135
Southern Arizona VA Health Care System
|
136
Miami Bruce Carter VA Health Care System
137
San Francisco VA Health Care System
|
138
Bay Pines VA Healthcare System
|
139
Veterans Affairs Palo Alto Health Care System
|
140
VA Long Beach Healthcare System
|
143
Herlev-Gentofte Hospital, Respiratory Medicine Section, Department of Internal Medicine
|
148
Kolding Hospital, Department of Medicine
|
150
Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark
|
152
Spain INSIGHT SCC Spain, Hospital Universitari Germans Trias i Pujol, Badalona
|
153
Hospital Universitari Germans Trias i Pujol, Badalona
|
154
Hospital General Universitario Gregorio Marañón, Madrid
|
156
Hospital Universitario La Paz, IdiPAZ, Madrid
157
Hospital Clínico San Carlos, Madrid
158
Hospital Universitary Vall d’Hebron, Barcelona
159
Internal Medicine Department, University Hospital Arnau de Vilanova, Lleida
|
161
Georgia SCC, Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia
|
162
Poland SCC, Wojewodzki Szpital Zakazny Warsaw
163
Ukraine Central City Clinical Hospital of Ivano-Frankivsk City, Ukraine
|
165
Tan Tock Seng Hospital, NCID, Singapore
|
166
Institute of Human Virology-Nigeria (IHVN)
167
Chennai Antiviral Research and Treatment Clinical Research Site, India
|
168
INSIGHT SCC Argentina, Coordinación en Investigación Clínica Académica en Latinoamérica
169
Hospital General de Agudos JM Ramos Mejia, Buenos Aires
170
Hospital Italiano de Buenos Aires, Buenos Aires
|
171
Centro de Educacion Medica e Investigaciones Clinicas, Buenos Aires
|
172
INSIGHT London ICC, MRC Clinical Trials Unit at UC, London, United Kingdom
|
173
United Kingdom SCC: Royal Free Hospital
174
Royal Victoria Infirmary
176
180
Alexandroupolis General Hospital, Medical School, Democritus University of Thrace
|
182
Gulu Regional Referral Hospital
|
184
Lira Regional Referral Hospital
|
185
Masaka Regional Referral Hospital
|
186
St. Francis Hospital, Nsambya
187
CISPOC: Centro de Investigaçäo e Treino em Saúde da Polana Caniço, Maputo, Mozambique
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188
Gilead Sciences, Foster CIty, California
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189
Molecular Partners and Novartis
190
191
PCI Pharma Services
Publication type: Journal Article
Publication date: 2022-08-08
Journal:
Annals of Internal Medicine
Q1
Q1
SJR: 3.337
CiteScore: 23.9
Impact factor: 19.6
ISSN: 00034819, 15393704
DOI:
10.7326/M22-1503
General Medicine
Internal Medicine
Abstract
Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.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.Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).Multinational, multicenter trial.Adults hospitalized with COVID-19.Intravenous ensovibep, 600 mg, or placebo.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.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).The trial was prematurely stopped because of futility, limiting power for the primary outcome.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.National Institutes of Health.
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MDPI
3 publications, 16.67%
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American College of Physicians
2 publications, 11.11%
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Elsevier
2 publications, 11.11%
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|
Wiley
1 publication, 5.56%
|
|
Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii
1 publication, 5.56%
|
|
Massachusetts Medical Society
1 publication, 5.56%
|
|
1
2
3
4
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- We do not take into account publications without a DOI.
- Statistics recalculated only for publications connected to researchers, organizations and labs registered on the platform.
- Statistics recalculated weekly.
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GOST
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Barkauskas C. et al. Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 // Annals of Internal Medicine. 2022. Vol. 175. No. 9. pp. 1266-1274.
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Barkauskas C. et al. Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 // Annals of Internal Medicine. 2022. Vol. 175. No. 9. pp. 1266-1274.
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RIS
Cite this
BibTex (up to 50 authors)
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@article{2022_Barkauskas,
author = {Christina Barkauskas and Garyfallia Poulakou and Barnaby E Young and David M. Vock and Lianne Siegel and Nicole Engen and Greg Grandits and Nilima R Mosaly and Andrew M. Vekstein and Konstantinos N Syrigos and Vasiliki Rapti and David C Lye and Diong Shiau Hui and Lindsay Leither and Kirk U. Knowlton and Rubria Marines-Price and J. Scott Overcash and Ioannis Kalomenidis and Zafeiria Barmparessou and Michael Waters and Karla Zepeda and Peter Chen and Sam Torbati and Nicholus Sebudde and Alyssa Hughes and Sanjay R Bhagani and Alison Rodger and Uriel Sandkovsky and Robert L. Gottlieb and Eriobu Nnakelu and Barbara Trautner and Vidya Menon and Michael Matthay and Philip Robinson and Konstantinos Protopapas and Nikolaos Koulouris and Amiran Baduashvili and Dominique L. Braun and Huldrych F. Günthard and Srikanth Ramachandruni and Robert Kidega and Kami Kim and Timothy J. Hatlen and Andrew N. Phillips and Daniel D. Murray and Tomas O Jensen and Maria L. Padilla and Evan X Accardi and Katy Shaw Saliba and Robin L. Dewar and others},
title = {Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19},
journal = {Annals of Internal Medicine},
year = {2022},
volume = {175},
publisher = {American College of Physicians},
month = {aug},
url = {https://doi.org/10.7326/M22-1503},
number = {9},
pages = {1266--1274},
doi = {10.7326/M22-1503}
}
Cite this
MLA
Copy
Barkauskas, Christina, et al. “Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19.” Annals of Internal Medicine, vol. 175, no. 9, Aug. 2022, pp. 1266-1274. https://doi.org/10.7326/M22-1503.
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