Open Access
Open access
American Medical Association (AMA)
JAMA network open
,  volume 7 ,  issue 12 ,  pages e2448215

Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia

Sean P. Collins 1, 2
, 
Matthew S. Shotwell 3
, 
Jeffrey R. Strich 4
, 
Kevin W. Gibbs 5
, 
Marjolein de Wit 6
, 
D. Clark Files 5
, 
Michelle Harkins 7
, 
Kris Hudock 8
, 
Lisa H Merck 9
, 
Ari Moskowitz 10
, 
Krystle D. Apodaca 7
, 
Aaron Barksdale 11
, 
Basmah Safdar 12
, 
Ali Javaheri 13
, 
Jeffrey M. Sturek 14
, 
Harry Schrager 15
, 
Nicole M. Iovine 16
, 
Ivor Douglas 17
, 
Joseph Levitt 18
, 
Adit A. Ginde 19
, 
David N. Hager 20
, 
Abhijit Duggal 21
, 
Akram Khan 22
, 
Michael Lanspa 23
, 
Peter Chen 24
, 
Estelle Harris 25
, 
Subhashini Sellers 26
, 
Andrew J. Goodwin 27
, 
Michael Filbin 28
, 
Felix Gutiérrez 29
, 
Vicente Estrada 30
, 
Jose R. Paño-Pardo 31
, 
Yves Rosenberg 32
, 
James Troendle 32
, 
Gordon R. Bernard 33, 34
, 
Amanda J Bistran-Hall 34
, 
Kelly Walsh 34
, 
Jonathan D. Casey 33
, 
Josh DeClercq 3
, 
Meghan Morrison Joly 34
, 
Jill Pulley 34
, 
Todd W. Rice 33, 34
, 
Jonathan S. Schildcrout 3
, 
Li Wang 3
, 
Matthew W. Semler 33
, 
Wesley H. Self 1, 34
, 
Richard C Becker 35
, 
Gregory del Zoppo 35
, 
Peter Henke 35
, 
Richard Holubkov 35
, 
MARYL JOHNSON 35
, 
Kim Kerr 35
, 
Hannah I. Lipman 35
, 
Fedor Lurie 35
, 
BERTRAM PITT 35
, 
Sara K. Vesely 35
, 
Jerome L. Fleg 35
, 
Dave Aamodt 35
, 
Debra Clark 35
, 
Jessica B Collins 35
, 
Sheri Dixon 35
, 
Maya Cook 35
, 
Carly Gatewood 35
, 
John Graves 35
, 
Debbie Hunter 35
, 
Courtney Jordan 35
, 
Sahar Ko 35
, 
Ugo (Ben) Lekqauwa 35
, 
Itzel Lopez 35
, 
David McKeel 35
, 
Dirk Orozco 35
, 
Nelson Prato 35
, 
Ally Qi 35
, 
Kalley Stagner 35
, 
Krista Vermillion 35
, 
Stephanie Winchell 35
, 
Taylor Young 35
, 
Esteban Masuda 35
, 
Asif Siddiqui 35
, 
Caroline Brooks 35
, 
Carl Fletcher 35
, 
Annie Duffy 35
, 
Paul Walsh 35
, 
Jack Moody 35
, 
Toni Sobande 35
, 
Amina Ali 35
, 
Yomi Henry 35
, 
Frances Ogueri 35
, 
Alba Sierto 35
, 
Maria Sanchez Grande 35
, 
Chiara Spinello 35
, 
Olufunke Anthony 35
, 
Michal Sieracki 35
, 
Michaella Tomlin 35
, 
Anton Pozniak 35
, 
Tim Leaver 35
, 
Polly Parks 35
, 
Jakea Johnson 35
, 
Ryan Walsh 35
, 
Brian Bales 35
, 
Karen Miller 35
, 
Donna Torr 35
, 
Clark Files 35
, 
Kevin Gibbs 35
, 
Darija Ward 35
, 
Leigha Landreth 35
, 
Lisa Parks 35
, 
Lori Flores 35
, 
J. Pedro Teixeira 35
, 
Sandra Cardenas 35
, 
Juan A. Ceniceros 35
, 
Amy G. Cunningham 35
, 
Susan Kunkel 35
, 
Debbie M. Lovato 35
, 
Brooklin Zimmerman 35
, 
Thanh Nguyen 35
, 
Wesley Zeger 35
, 
Noah Wiedel 35
, 
Stephanie Stilinovic 35
, 
Caroline Foster 35
, 
Jeanne Flannigan 35
, 
Carolyn Brokowski 35
, 
Jing Lu 35
, 
Muriel Solberg 35
, 
Dana Lee 35
, 
Brian Tiffany 35
, 
Charlotte Tanner 35
, 
ANNETTE TAYLOR 35
, 
Jennine Zumbahl 35
, 
Aamer Syed 35
, 
Jessica Mason 35
, 
Patrick E H Jackson 35
, 
Rachael W. Coleman 35
, 
Heather M Haughey 35
, 
Kartik Cherabuddi 35
, 
Rebecca Wakeman 35
, 
Kathryn Fairbank-Haynes 35
, 
Angela J. Rogers 35
, 
Jennifer G. Wilson 35
, 
Rosemary Vojnik 35
, 
Cynthia Perez 35
, 
David Wyles 35
, 
Terra D. Hiller 35
, 
Judy L. Oakes 35
, 
Ana Z. Garcia 35
, 
Flora Martinez 35
, 
Jennifer Fickes-Siler 35
, 
David J. Douin 35
, 
Amiran Baduashvili 35
, 
Henry Kramer 35
, 
Lakshmi Chauhan 35
, 
Amanda Martinez 35
, 
Jennifer Peers 35
, 
Kristine Schauer 35
, 
Lani Finck 35
, 
Jill Bastman 35
, 
Ashley Licursi 35
, 
Sharon Hayes 35
, 
Nicholas Kurtzman 35
, 
Elinita Rosseto 35
, 
Douglas Scaffidi 35
, 
Nathan Shapiro 35
, 
Jonathan Pak 35
, 
Gopal Allada 35
, 
Genesis Briceno 35
, 
Jose Peña 35
, 
Minn Oh 35
, 
Michelle Gong 35
, 
Amira Mohamed 35
, 
Luke Andrea 35
, 
Rahul Nair 35
, 
William Nkemdirim 35
, 
Sabah Boujid 35
, 
Martha Torres 35
, 
Ofelia Garcia 35
, 
Harith Ali 35
, 
Sasha Beselman 35
, 
Yolanda Eby 35
, 
Vitaliy Klimov 35
, 
R. Duncan Hite 35
, 
Hammad Tanzeem 35
, 
Chris Droege 35
, 
Jessica Winter 35
, 
Simon Mucha 35
, 
Nirosshan Thiruchelvam 35
, 
Matthew Siuba 35
, 
Omar Mehkri 35
, 
Susan Jackman 35
, 
Antonina Caudill 35
, 
Emad Bayoumi 35
, 
Ethan Pascual 35
, 
Po-En Chen 35
, 
Sam S Torbati 35
, 
Tanyalak Parimon 35
, 
Bradley Rosen 35
, 
Yuri Matusov 35
, 
Michael J. Lanspa 35
, 
Ithan D. Peltan 35
, 
Samuel M. Brown 35
, 
Jason R. Carr 35
, 
Daniel B. Knox 35
, 
Lindsay M Leither 35
, 
Brenda Lopez 35
, 
Benjamin Galen 35
, 
Nina Gentile 35
, 
Derek Isenberg 35
, 
Hannah Reimer 35
, 
Paul Cincola 35
, 
Estelle S. Harris 35
, 
Sean J. Callahan 35
, 
Misty B Yamane 35
, 
Macy AG Barrios 35
, 
Neeraj Desai 35
, 
Amit Bharara 35
, 
Michael Keller 35
, 
Prat Majumder 35
, 
Carrie Dohe 35
, 
Kathryn Hibbert 35
, 
Justin Margolin 35
, 
Blair Parry 35
, 
Mark A. Tidswell 35
, 
Jay S Steingrub 35
, 
Lesley De Souza 35
, 
Cynthia Kardos 35
, 
Denise Gallant 35
, 
Rae Lynn DeFoe 35
, 
Sara Romain 35
, 
Scott Ouellette 35
, 
Serena Estrada 35
, 
Ryan Kindle 35
, 
Bogdan Tiru 35
, 
Howard Smithline 35
, 
CAROLYN GARCIA 35
, 
Charles Terry 35
, 
Melissa Blender 35
, 
Abbey Grady 35
, 
Andrew Powell 35
, 
Peter C. Hou 35
, 
Mohammad A Hasdianda 35
, 
Seven E. Miyawaki 35
, 
Mikita Umale 35
, 
Valeria D. Cantos 35
, 
Colleen F. Kelley 35
, 
Paulina A. Rebolledo 35
, 
Sheetal Kandiah 35
, 
Renee Cook 35
, 
Betsy Hall 35
, 
Christin Root 35
, 
Juliet Brown 35
, 
Christopher Foster 35
, 
Philip Powers 35
, 
Pamela Lankford-Turner 35
, 
Bela Patel 35
, 
Rodeo Abrencillo 35
, 
Robier Anguillon-Prada 35
, 
Ryan Huebinger 35
, 
Gabriel Patarroyo Aponte 35
, 
Syed Ghazi Rizvi 35
, 
Elizabeth Vidales 35
, 
Idorenyin Udoh-Bradford 35
, 
Mar Masiá 35
, 
Sergio Padilla 35
, 
Guillermo Telenti 35
, 
Paula Mascarell 35
, 
Javier García-Abellán 35
, 
Ángela Botella 35
, 
Catalina Robledano 35
, 
Vincente Estrada 35
, 
Reynaldo Homen 35
, 
Javier Rodriguez-Añover 35
, 
Joaquin Burgos 35
, 
Tom Boyles 35
, 
Zanele Mkhabela 35
, 
Galadriel Pellejero 35
, 
Elena Morte-Romea 35
, 
Santiago Letona-Carbajo 35
, 
María José Esquillor 35
, 
Carla Toyas 35
, 
Silvia Loscos 35
, 
Nazreen Hussen 35
, 
Carlos Guijarro 35
, 
Maria Velasco-Arribas 35
, 
Esaú Custódio João Filho 35
, 
Elaine C. de Oliveira Souza 35
, 
Christoph Boesecke 35
, 
Jurgen Rockstroh 35
, 
Marco Ripa 35
, 
Silvia Nozza 35
1
 
2
 
Veterans Affairs Tennessee Valley Healthcare System, Geriatric Research, Education and Clinical Center, Nashville, Tennessee | 
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Department of Medicine, Montefiore Medical Center, Bronx, New York | 
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Department of Medicine, Denver Health Medical Center, Denver, Colorado | 
18
 
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Department of Medicine, Intermountain Medical Center, Murray, Utah | 
24
 
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for the ACTIV-4 Host Tissue Investigators
Publication type: Journal Article
Publication date: 2024-12-03
American Medical Association (AMA)
scimago Q1
wos Q1
SJR: 3.546
CiteScore: 13.8
Impact factor: 9.7
ISSN: 25743805
Abstract
Importance

Fostamatinib, a spleen tyrosine kinase inhibitor, has been reported to improve outcomes of COVID-19.

Objective

To evaluate the efficacy and safety of fostamatinib in adults hospitalized with COVID-19 and hypoxemia.

Design, Setting, and Participants

This multicenter, phase 3, placebo-controlled, double-blinded randomized clinical trial was conducted at 41 US sites and 21 international sites between November 17, 2021, and September 27, 2023; the last follow-up visit was December 31, 2023. Participants were adults aged 18 years or older hospitalized with acute SARS-CoV-2 infection and hypoxemia. Data were analyzed between January 10 and March 8, 2024.

Interventions

Fostamatinib, 150 mg orally twice daily for 14 days, or placebo.

Main Outcomes and Measures

The primary outcome was oxygen-free days, an ordinal outcome classifying a participant’s status at day 28 based on mortality and duration of supplemental oxygen use. An adjusted odds ratio (AOR) greater than 1.0 was considered to indicate superiority of fostamatinib over placebo. A key secondary outcome was 28-day all-cause mortality. Safety outcomes included elevated transaminase values, neutropenia, and hypertension.

Results

Of the 400 participants randomized (median age, 67 years [IQR, 58-76 years]; 210 [52.5%] men), 199 received fostamatinib and 201 received placebo. The mean (SD) number of oxygen-free days was 13.4 (12.4) in the fostamatinib group and 14.2 (12.1) in the placebo group (unadjusted mean difference, −1.26 days [95% CI, −3.52 to 1.00 days]; AOR, 0.82 [95% credible interval (CrI), 0.58-1.17]). Mortality at 28 days occurred in 22 of 195 patients (11.3%) in the fostamatinib group and 16 of 197 (8.1%) in the placebo group (AOR, 1.44; 95% CrI, 0.72-2.90). Aspartate aminotransferase elevation occurred more commonly in the fostamatinib group (23 [11.6%]) than in the placebo group (11 [5.5%]; AOR, 2.28; 95% CrI, 1.07-4.84). Other safety outcomes were similar between groups.

Conclusions and Relevance

In this randomized clinical trial of adults hospitalized with COVID-19 and hypoxemia, fostamatinib did not increase the number of oxygen-free days compared with placebo. These results do not support the hypothesis that fostamatinib improves outcomes among adults hospitalized with hypoxemia during the Omicron era.

Trial Registration

ClinicalTrials.gov Identifier: NCT04924660

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Collins S. P. et al. Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia // JAMA network open. 2024. Vol. 7. No. 12. p. e2448215.
GOST all authors (up to 50) Copy
Collins S. P. et al. Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia // JAMA network open. 2024. Vol. 7. No. 12. p. e2448215.
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BibTex (up to 50 authors) Copy
@article{2024_Collins,
author = {Sean P. Collins and Matthew S. Shotwell and Jeffrey R. Strich and Kevin W. Gibbs and Marjolein de Wit and D. Clark Files and Michelle Harkins and Kris Hudock and Lisa H Merck and Ari Moskowitz and Krystle D. Apodaca and Aaron Barksdale and Basmah Safdar and Ali Javaheri and Jeffrey M. Sturek and Harry Schrager and Nicole M. Iovine and Ivor Douglas and Joseph Levitt and Adit A. Ginde and David N. Hager and Abhijit Duggal and Akram Khan and Michael Lanspa and Peter Chen and Estelle Harris and Subhashini Sellers and Andrew J. Goodwin and Michael Filbin and Felix Gutiérrez and Vicente Estrada and Jose R. Paño-Pardo and Yves Rosenberg and James Troendle and Gordon R. Bernard and Amanda J Bistran-Hall and Kelly Walsh and Jonathan D. Casey and Josh DeClercq and Meghan Morrison Joly and Jill Pulley and Todd W. Rice and Jonathan S. Schildcrout and Li Wang and Matthew W. Semler and Wesley H. Self and Richard C Becker and Gregory del Zoppo and Peter Henke and Richard Holubkov and others},
title = {Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia},
journal = {JAMA network open},
year = {2024},
volume = {7},
publisher = {American Medical Association (AMA)},
month = {dec},
url = {https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2827330},
number = {12},
pages = {e2448215},
doi = {10.1001/jamanetworkopen.2024.48215}
}
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Cite this
MLA Copy
Collins, Sean P., et al. “Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia.” JAMA network open, vol. 7, no. 12, Dec. 2024, p. e2448215. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2827330.