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Authors
Costa Monteiro, Ana C.
Pickering, Harry
Sarma, Aartik
Taylor, Clove S.
Jenkins, Meagan M.
Hsu, Fei-Man
Nadel, Brian
Levy, Ofer
Baden, Lindsey R.
Melamed, Esther
Ehrlich, Lauren I. R.
McComsey, Grace A.
Sekaly, Rafick P.
Cairns, Charles B.
Haddad, Elias K.
Shaw, Albert C.
Hafler, David A.
Montgomery, Ruth R.
Corry, David B.
Kheradmand, Farrah
Atkinson, Mark A.
Brakenridge, Scott C.
Higuita, Nelson I. Agudelo
Metcalf, Jordan P.
Hough, Catherine L.
Messer, William B.
Pulendran, Bali
Nadeau, Kari C.
Davis, Mark M.
Geng, Linda N.
Fernandez-Sesma, Ana
Simon, Viviana
Krammer, Florian
Kraft, Monica
Bime, Chris
Calfee, Carolyn S.
Erle, David J.
Bosinger, Steve
Eckalbar, Walter
Maecker, Holden
Rahman, Adeeb
Guan, Leying
Peters, Bjoern
Kleinstein, Steven H.
Augustine, Alison D.
Diray-Arce, Joann
Becker, Patrice M.
Rouphael, Nadine
,
Becker, Patrice M.
Augustine, Alison D.
Holland, Steven M.
Rosen, Lindsey B.
Lee, Serena
Vaysman, Tatyana
Ozonoff, Al
Diray-Arce, Joann
Chen, Jing
Kho, Alvin
Milliren, Carly E.
Hoch, Annmarie
Chang, Ana C.
McEnaney, Kerry
Barton, Brenda
Lentucci, Claudia
Murphy, Maimouna D.
Saluvan, Mehmet
Shaheen, Tanzia
Liu, Shanshan
Syphurs, Caitlin
Albert, Marisa
Hayati, Arash Nemati
Bryant, Robert
Abraham, James
Thomas, Sanya
Cooney, Mitchell
Karoly, Meagan
Altman, Matthew C.
Jayavelu, Naresh Doni
Presnell, Scott
Kohr, Bernard
Jancsyk, Tomasz
Arnett, Azlann
Peters, Bjoern
Overton, James A.
Vita, Randi
Westendorf, Kerstin
Overton, James A.
Levy, Ofer
Steen, Hanno
van Zalm, Patrick
Fatou, Benoit
Smolen, Kinga K.
Viode, Arthur
van Haren, Simon
Jha, Meenakshi
Stevenson, David
Baden, Lindsey R.
Mendez, Kevin
Lasky-Su, Jessica
Tong, Alexandra
Rooks, Rebecca
Desjardins, Michael
Sherman, Amy C.
Walsh, Stephen R.
Mitre, Xhoi
Cauley, Jessica
Li, Xiofang
Evans, Bethany
Montesano, Christina
Licona, Jose Humberto
Krauss, Jonathan
Issa, Nicholas C.
Park Chang, Jun Bai
Izaguirre, Natalie
Hutton, Scott R.
Michelotti, Greg
Wong, Kari
Tebbutt, Scott J.
Shannon, Casey P.
Sekaly, Rafick-Pierre
Fourati, Slim
McComsey, Grace A.
Harris, Paul
Sieg, Scott
Yendewa, George
Consolo, Mary
Tribout, Heather
Pereira Ribeiro, Susan
Cairns, Charles B.
Haddad, Elias K.
Kutzler, Michele A.
Bernui, Mariana
Cusimano, Gina
Connors, Jennifer
Woloszczuk, Kyra
Joyner, David
Edwards, Carolyn
Lee, Edward
Lin, Edward
Melnyk, Nataliya
Powell, Debra L.
Kim, James N.
Goonewardene, I. Michael
Simmons, Brent
Smith, Cecilia M.
Martens, Mark
Croen, Brett
Semenza, Nicholas C.
Bell, Mathew R.
Furukawa, Sara
McLin, Renee
Tegos, George P.
Rogowski, Brandon
Mege, Nathan
Ulring, Kristen
Schearer, Pam
Sheidy, Judie
Nagle, Crystal
Seyfert-Margolis, Vicki
Rouphael, Nadine
Bosinger, Steven E.
Boddapati, Arun K.
Tharp, Greg K.
Wimalasena, Sonia
Pellegrini, Kathryn L.
Johnson, Brandi
Panganiban, Bernadine
Huerta, Christopher
Anderson, Evan J.
Samaha, Hady
Sevransky, Jonathan E.
Bristow, Laurel
Beagle, Elizabeth
Cowan, David
Hamilton, Sydney
Hodder, Thomas
Bechnak, Amer
Cheng, Andrew
Mehta, Aneesh
Ciric, Caroline R.
Spainhour, Christine
Carter, Erin
Scherer, Erin M.
Usher, Jacob
Hellmeister, Kieffer
Hussaini, Laila
Hewitt, Lauren
Mcnair, Nina
Fernandez-Sesma, Ana
Simon, Viviana
Krammer, Florian
Van Bakel, Harm
Kim-Schulze, Seunghee
Gonzalez-Reiche, Ana Silvia
Qi, Jingjing
Lee, Brian
Carreño, Juan Manuel
Singh, Gagandeep
Raskin, Ariel
Tcheou, Johnstone
Khalil, Zain
van de Guchte, Adriana
Farrugia, Keith
Khan, Zenab
Kelly, Geoffrey
Srivastava, Komal
Eaker, Lily Q.
Bermúdez-González, Maria C.
Mulder, Lubbertus C. F.
Beach, Katherine F.
Saksena, Miti
Altman, Deena
Kojic, Erna
Sominsky, Levy A.
Azad, Arman
Bielak, Dominika
Kawabata, Hisaaki
Yellin, Temima
Fried, Miriam
Sullivan, Leeba
Morris, Sara
Kleiner, Giulio
Stadlbauer, Daniel
Dutta, Jayeeta
Xie, Hui
Patel, Manishkumar
Nie, Kai
Rahman, Adeeb
Messer, William B.
Hough, Catherine L.
Siegel, Sarah A. R.
Sullivan, Peter E.
Lu, Zhengchun
Brunton, Amanda E.
Strand, Matthew
Lyski, Zoe L.
Coulter, Felicity J.
Micheleti, Courtney
Maecker, Holden
Pulendran, Bali
Nadeau, Kari C.
Rosenberg-Hasson, Yael
Leipold, Michael
Sigal, Natalia
Rogers, Angela
Fernandes, Andrea
Manohar, Monali
Do, Evan
Chang, Iris
Lee, Alexandra S.
Blish, Catherine
Din, Henna Naz
Roque, Jonasel
Geng, Linda N.
Artandi, Maja
Davis, Mark M.
Ahuja, Neera
Yang, Samuel S.
Chinthrajah, Sharon
Hagan, Thomas
Reed, Elaine F.
Schaenman, Joanna
Salehi-Rad, Ramin
Rivera, Adreanne M.
Pickering, Harry C.
Sen, Subha
Elashoff, David
Ward, Dawn C.
Brook, Jenny
Ramires-Sanchez, Estefania
Llamas, Megan
Perdomo, Claudia
Magyar, Clara E.
Fulcher, Jennifer
Erle, David J.
Calfee, Carolyn S.
Hendrickson, Carolyn M.
Kangelaris, Kirsten N.
Nguyen, Viet
Lee, Deanna
Chak, Suzanna
Ghale, Rajani
Gonzalez, Ana
Jauregui, Alejandra
Leroux, Carolyn
Torres Altamirano, Luz
Sadeed Rashid, Ahmad
Willmore, Andrew
Woodruff, Prescott G.
Krummel, Matthew F.
Carrillo, Sidney
Ward, Alyssa
Langelier, Charles R.
Patel, Ravi
Wilson, Michael
Dandekar, Ravi
Alvarenga, Bonny
Rajan, Jayant
Eckalbar, Walter
Schroeder, Andrew W.
Fragiadakis, Gabriela K.
Tsitsiklis, Alexandra
Mick, Eran
Sanchez Guerrero, Yanedth
Love, Christina
Maliskova, Lenka
Adkisson, Michael
Leligdowicz, Aleksandra
Beagle, Alexander
Rao, Arjun
Sigman, Austin
Samad, Bushra
Curiel, Cindy
Shaw, Cole
Tietje-Ulrich, Gayelan
Milush, Jeff
Singer, Jonathan
Vasquez, Joshua J.
Tang, Kevin
Betancourt, Legna
Santhosh, Lekshmi
Pierce, Logan
Tecero Paz, Maria
Matthay, Michael
Thakur, Neeta
Rodriguez, Nicklaus
Sutter, Nicole
Jones, Norman
Sinha, Pratik
Prasad, Priya
Lota, Raphael
Rashid, Sadeed
Asthana, Saurabh
Bhide, Sharvari
Lea, Tasha
Abe-Jones, Yumiko
Hafler, David A.
Montgomery, Ruth R.
Shaw, Albert C.
Kleinstein, Steven H.
Gygi, Jeremy P.
Pawar, Shrikant
Konstorum, Anna
Chen, Ernie
Cotsapas, Chris
Wang, Xiaomei
Xu, Leqi
Dela Cruz, Charles
Iwasaki, Akiko
Mohanty, Subhasis
Nelson, Allison
Zhao, Yujiao
Farhadian, Shelli
Asashima, Hiromitsu
Chaudhary, Omkar
Coppi, Andreas
Fournier, John
Muenker, M. Catherine
Nelson, Allison
Raddassi, Khadir
Rainone, Michael
Ruff, William
Salahuddin, Syim
Shulz, Wade L.
Vijayakumar, Pavithra
Wang, Haowei
Wunder, Esio Jr.
Young, H. Patrick
Ko, Albert I.
Wang, Xiomei
Esserman, Denise
Guan, Leying
Brito, Anderson
Rothman, Jessica
Grubaugh, Nathan D.
Corry, David B.
Kheradmand, Farrah
Song, Li-Zhen
Nelson, Ebony
Metcalf, Jordan P.
Higuita, Nelson I. Agudelo
Sinko, Lauren A.
Booth, J. Leland
Drevets, Douglas A.
Brown, Brent R.
Kraft, Monica
Bime, Chris
Mosier, Jarrod
Erickson, Heidi
Schunk, Ron
Kimura, Hiroki
Conway, Michelle
Francisco, Dave
Molzahn, Allyson
Wilson, Connie Cathleen
Schunk, Ron
Hughes, Trina
Sierra, Bianca
Atkinson, Mark A.
Brakenridge, Scott C.
Ungaro, Ricardo F.
Manning, Brittany Roth
Moldawer, Lyle
Oberhaus, Jordan
Guirgis, Faheem W.
Borresen, Brittney
Anderson, Matthew L.
Ehrlich, Lauren I. R.
Melamed, Esther
Maguire, Cole
Wylie, Dennis
Rousseau, Justin F.
Hurley, Kerin C.
Geltman, Janelle N.
Siles, Nadia
Rogers, Jacob E.
Tipan, Pablo Guaman
,
Agus, Michael
Srinivasan, Vijay
Chima, Ranjit S.
Thomas, Neal J.
Li, Simon
Pinto, Alan
Newth, Christopher
Hassinger, Amanda B.
Bysani, Kris
Faustino, Edward Vincent
Hirshberg, Eliotte
Wintergerst, Kupper
Sullivan, Janice E.
Schwarz, Adam
Sorce, Lauren
Marsillio, Lauren
Cvijanovich, Natalie
Flori, Heidi
Pham, Nga
Dahmer, Mary
Federman, Myke
Wong, Kayley
Vangala, Sitaram S.
Pellegrini, Matteo
Balliu, Brunilda
Gala, Kinisha P.
Nett, Sholeen
Singleton, Marcy
Pinto, Neethi
Chong, Grace
Viteri, Shirley
Sapru, Anil
McQuillen, Patrick
Zinter, Matt
Agus, Michael
Kulkarni, Hrishikesh
Schaenmann, Joanna M.
Salehi-Rad, Ramin
Matthay, Michael A.
Reed, Elaine F.
Sapru, Anil
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Funding
Funding for this research was provided by:
National Heart, Lung, and Blood Institute (K23HL165149, U01HL107681, R01-HL166449, R01-HL169860, R01HL170601)
National Institutes of Health (R01AI104870, R01AI132774, R01AI135803, R01AI145835, U19AI057229, U19AI062629, U19AI077439, U19AI089992, U19AI090023, U19AI118608, U19AI118610, U19AI125357, U19AI128910, U19AI128913, U54AI142766, U19AI089992, U24AI52179, P51 OD011132, S10 OD026799, R01HL114484)
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Article History
Received: 21 April 2025
Accepted: 1 August 2025
First Online: 14 October 2025
Declarations
:
: CAFPINT/HAFPINT- The study was coordinated by a Clinical Coordinating Center (CCC) with staff from both CCC Principal Investigators’ sites (PIs MA, VN) and a Data Coordinating Center (DCC; PI DW, U01 HL108028). Patients were screened and recruited at 35 sites in the United States, Canada, and Australia. Central ethics review was arranged at the Boston Children’s Hospital Institutional Review Board (IRB) to be available for sites willing to cede ethics review authority with appropriate signed institutional agreements. Ten sites established this reliance relationship, while the remaining sites conducted local IRB review and oversight. Study protocol modifications were developed collaboratively between the study’s ten-member leadership committee and a steering committee comprised of co-investigators from all participating sites.Families of potential study patients were approached by the local study team upon confirmation of hyperglycemia [two consecutive BGs of ≥ 150 mg/dL (8.3 mmol/L)] after obtaining permission from the attending physician to approach the family. Attending physicians were asked to confirm that eligible female patients were not pregnant prior to their families being approached to minimize any risk to the fetus from study-induced hypoglycemia. An informed consent and/or assent discussion with the family and/or patient took place in the ICU or in a nearby private room. Patients whose families declined participation in the study were managed according to usual practice by the local clinical team, which may or may not have included therapy for glycemic control. Consented subjects with confirmed hyperglycemia were randomized to one of the two treatment arms.IMPACC: NIAID staff conferred with the Department of Health and Human Services Office for Human Research Protections (OHRP) regarding the potential applicability of the public health surveillance exception [45CFR46.102(l) (2)] to the IMPACC study protocol. OHRP concurred that the study satisfied criteria for the public health surveillance exception, and the IMPACC study team sent the study protocol, and participant information sheet for review and assessment to institutional review boards (IRBs) at participating institutions. Twelve institutions elected to conduct the study as public health surveillance, while 3 sites with prior IRB-approved biobanking protocols elected to integrate and conduct IMPACC under their institutional protocols (University of Texas at Austin, IRB 2020-04-0117; University of California San Francisco, IRB 20-30497; Case Western Reserve University, IRB STUDY20200573) with informed consent requirements. Participants enrolled under the public health surveillance exclusion were provided information sheets describing the study, samples to be collected, and plans for data deidentification and use. Those who requested not to participate after reviewing the information sheet were not enrolled. In addition, participants did not receive compensation for study participation while inpatient, and subsequently were offered compensation during outpatient follow-ups.
: All authors have read the manuscript and have consented to its publication.
: The Icahn School of Medicine at Mount Sinai has filed patent applications relating to SARS-CoV-2 serological assays and NDV-based SARS-CoV-2 vaccines which list Florian Krammer as co-inventor. Mount Sinai has spun out a company, Kantaro, to market serological tests for SARS-CoV-2. Florian Krammer has consulted for Merck and Pfizer (before 2020), and is currently consulting for Pfizer, Seqirus, 3rd Rock Ventures, Merck and Avimex. The Krammer laboratory is also collaborating with Pfizer on animal models of SARS-CoV-2. Viviana Simon is a co-inventor on a patent filed relating to SARS-CoV-2 serological assays (the “Serology Assays”). Ofer Levy is a named inventor on patents held by Boston Children’s Hospital relating to vaccine adjuvants and human in vitro platforms that model vaccine action. His laboratory has received research support from GlaxoSmithKline (GSK) and he has served as a consultant for GSK and Hillevax. He is also a co-founder of and advisor to Ovax, Inc, a company developing vaccines against opioid overdose. Charles Cairns serves as a consultant to bioMerieux and is funded for a grant from Bill & Melinda Gates Foundation. James A Overton is a consultant at Knocean Inc. Jessica Lasky-Su serves as a scientific advisor of Precion Inc. Scott R. Hutton, Greg Michelloti and Kari Wong are employees of Metabolon Inc. Vicki Seyfer- Margolis is a current employee of MyOwnMed. Emory University receives funds for Nadine Rouphael to conduct research from Sanofi, Lilly, Merck, Quidel, Immorna, Vaccine Company and Pfizer. Nadine Rouphael served on selected advisory boards for Sanofi, Seqirus, Pfizer and Moderna and is a paid clinical trials safety consultant for ICON, CyanVac, Imunon and EMMES. Adeeb Rahman is a current employee of Immunai Inc. Steven Kleinstein is a consultant related to ImmPort data repository for Peraton. Nathan Grabaugh is a consultant for Tempus Labs and the National Basketball Association. Akiko Iwasaki is a consultant for 4BIO, Blue Willow Biologics, Revelar Biotherapeutics, RIGImmune, Xanadu Bio, Paratus Sciences. Monika Kraft receives research funds paid to her institution from NIH, ALA; Sanofi, Astra-Zeneca for work in asthma, serves as a consultant for Astra-Zeneca, Sanofi, Chiesi, GSK for severe asthma; is a co-founder and CMO for RaeSedo, Inc, a company created to develop peptidomimetics for treatment of inflammatory lung disease. Esther Melamed received research funding from Babson Diagnostics, honorarium from Multiple Sclerosis Association of America and has served on advisory boards of Genentech, Horizon, Teva and Viela Bio. Carolyn Calfee receives research funding from NIH, FDA, DOD, Roche-Genentech and Quantum Leap Healthcare Collaborative as well as consulting services for Janssen, Vasomune, Gen1e Life Sciences, NGMBio, and Cellenkos. Wade Schulz was an investigator for a research agreement, through Yale University, from the Shenzhen Center for Health Information for work to advance intelligent disease prevention and health promotion; collaborates with the National Center for Cardiovascular Diseases in Beijing; is a technical consultant to Hugo Health, a personal health information platform; cofounder of Refactor Health, an AI-augmented data management platform for health care; and has received grants from Merck and Regeneron Pharmaceutical for research related to COVID-19. Grace A McComsey received research grants from Rehdhill, Cognivue, Pfizer, and Genentech, and served as a research consultant for Gilead, Merck, Viiv/GSK, and Jenssen. Linda N. Geng received research funding paid to her institution from Pfizer, Inc.
