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1. Ethnic and racial differences in children and young people with respiratory and neurological post-acute sequelae of SARS-CoV-2: an electronic health record-based cohort study from the RECOVER InitiativeResearch in context

Author

Suchitra Rao, Rodrigo Azuero-Dajud, Vitaly Lorman, Jeremy Landeo-Gutierrez, Kyung E. Rhee, Julie Ryu, C. Kim, Megan Carmilani, Rachel S. Gross, Sindhu Mohandas, Srinivasan Suresh, L. Charles Bailey, Victor Castro, Yalini Senathirajah, Shari Esquenazi-Karonika, Shawn Murphy, Steve Caddle, Lawrence C. Kleinman, Leah Castro-Baucom, Carlos R. Oliveira, Jonathan D. Klein, Alicia Chung, Lindsay G. Cowell, Charisse Madlock-Brown, Carol Reynolds Geary, Marion R. Sills, Lorna E. Thorpe, Jacqueline Szmuszkovicz, Kelan G. Tantisira, Ivan Diaz, Rachel Kenny, Parsa Mirhaji, Ravi Jhaveri, Marc Rosenman, Christopher Forrest, Beth Tarini, Hiroki Morizono, Nathan Pajor, W. Schuyler Jones, Kieler Curtis, Rishi Kamaleswaran, Nita Deshpande, Saul Blecker, Claudia Pulgarin, Marion Sills, Erin Hinkman, Dan Fort, Timothy Guthrie, Cynthia Chuang, Wenke Hwang, Dimitri Christakis, Daksha Ranade, Shannon Herring, Aaron Mishkin, Soledad Fernandez, Neena Thomas, Yuriy Bisyuk, Jyotsna Fuloria, Elizabeth Chrischilles, Boyd Knosp, Asa Oxner, Athanasios Tsalatsanis, Lindsay Cowell, Phillip Reeder, Stephen M. Downs, Brian Ostasiewski, Rainu Kaushal, Thomas Campion, Jessica Snowden, Katherine Irby, Paul Darden, Lexie Dixon, Danielle Evans, Connor Garbe, Laura Hobart-Porter, Lee Howard, Kathy Hummel, Hannah Krehbiel, Haley Spradlin, Phaedra Yount, Amy Elliott, Grace Adam, Jyoti Angal, Maria Barber, Katelynne Clark, Clayton Dos Reis, Mandy Freesemann, Christa Friedrich, Christine Hockett, Rachel Johannsen, Emily Johnson-Vonk, Cassidy Kaiser, Alexa Kruse, Jennifer Lang, Peter Lim, Meggie McCoy, Lorie Miller, Shelby Petereit (Cerkovnik), Jaime RiChard (Werpy), Jessica Seiler, Bret Sundleaf, Joshua Svendsen, Billy Trosper, Olivia Vermeulen, Scott Young, Aul Palumbo, Sean Dabney, Marie-Christine Fahrner, Torrey Gallagher, Karilyn Martini, Mary McNally, Sarah Vivensi Stiverson, Jessica Kosut, Venkataraman Balaraman, JoAnn Cheung, Travis K.F. Hong, Shanelle Kalua, Evan Minami, Andrea Siu, Micah Tong, Ronald J. Teufel, II, Andy Atz, Marina Dantas, Tyler Kasmarcak, Kreighton Milks, Judith Ross, Chijoke Ikomi, Marisa Meyer, Connie Nguyen, Gwen Pellicciotti, Thao-Ly Phan, Karen Ravin, Victoria Reynolds, Abigail Strang, Deepika Thacker, Dan Eckrich, Annabelle Goetter, Cheyenne Katz, Karen Kowal, Carol McDevitt, Emily Zimmerman, Genesis Agosto Roman, Akram Alshawabkeh, Ishwara Ayala Ortiz, Virginia Casey, Jose Cordero, Jocelyn De Jesus, Crystal Galan, Gredia Huerta-Montanez, Nilda Otero, Mayra Rivera Robles, Priscilla Roman, Genesis Roman, Zaira Rosario-Pabon, Xiodenis Santiago, Carmen Velez-Vega, Carlos Vergara, Daniel S. Hsia, Baylea Albarado, Tracey Allen, Allison Attuso, Taylor Ayers, Emily Bebler, Grace Bella, Alexa Bennett, John Brown, Alison Carville, Sydnie Darby, Kara Devall, Amber Dragg, Angela Elderedge, Elisabeth Fontenot, Greta Fry, Bethany Gildersleeve, Sara Goff, Lauren Harrington, Lisa Jones, Victoria Kaiser, Yejee Lee, Stephen Lee, Erin LeJeune, Robert Leonhard, Jennifer Levatino, Donald Lewis, Angrielle Lloyd, Ron Monce, Susannah Munro, Meghan Phillips, Blair Pucheu, Emily Rachal, Jennifer Rood, Stacey Roussel, Renee Rumsey, Connor Sanford, Monica Santos, Aryelle Stafford, Amy Thomassie, Celeste Waguespack, Katherine Walgamotte, Meredith Welch, Aubrey Windham, Michelle Stevenson, Tiffany Bell, Jackie Boyd, Soham Dasgupta, Sarah Deans, Katie Harris, Molly Hemmerle, Sarah King, Cameo McGuire, Brie Merten, Sarah Morris, Madison Ray, Brooklyn Reinhardt, Shellese Shemwell, Theresa Simeon, Katherine Walker, Sara Watson, Kathryn Weakley, Russell McCulloh, Johnathon Figliomeni, Laura Fischer, Denise Hoover, Megan Morse, Aleisha Nabower, Evan Roberts, Alice Sato, Joann Von Bon, Hengameh Raissy, David Archuleta, Rebecca Brito, Richard Campbell, Jude Chavez, Walter Dehority, Noella Garcia-Soberanez, Eve Gronert, Matthew Kadish, Jerry Larrabee, Debbie Lovato, Karen Luo, Noah Martinez, Analyse Merlino, Emily Reese, Sarah Ward, Kevin Wilson, Amanda Bogie, Ryan Brown, Ryan Butchee, Gina Fergeson, Ryan McKee, Brandon Mohler, Tiffany Moore, Valorie Owens, Sarah Stubbs, Timothy Van Wagoner, Kelly Cowan, Meghan Bethel, Laurie Chassereau, Thomas Lahiri, Lesley Cottrell, Lauren Lake, Kathy Moffett, Emily Polak, Sarah Stutler, Charlotte Workman, David Warburton, John C. Wood, Emma Carpenter, Isabelle Dhindsa, Samantha Mejia, Nelly Moghadam, Candice Mulder, Sharon O'Neil, Alisha Osornio, Adrian Rios, Sydney Rosen, Andrea Smith, Deeba Tabibi, Sharon Tang, Ariana Teame, Melissa Stockwell, Joshua Milner, Erika B. Rosenzweig, Brett Anderson, Tawanda Aquino, Elizabeth Berg, Marina Catallozzi, Wendy Chung, Tom Connors, Aliva De, Anny Diaz Perez, Michael DiLorenzo, Dani Dumitriu, Kanwal Farooqi, Michael Fremed, Sylvie Goldman, Kayla Kaplan, Usha Krishnan, Aimee Layton, Angela Lignelli-Dipple, Son McClaren, Jonathan Overdevest, Michelle Rodriguez, Jay Selman, Wendy Silver, Raul Silverio, Ana Valdez de Romero, Celibell Vargas, Alan Werzberger, Daniella Caputo, Camille Leggieri, Pamela Pretsch, Lawrence Kleinman, Sunanda Gaur, Lisa Cerracchio, Amber Folnagy, Maria Gennaro, Sherri Gzemski, Yue Hao, Simon Li, Sandee Moroso, Manette Ness-Cochinwala, Akhil Patel, Benjamin Richlin, Harsh Sharma, Damaris Soto, Christian Suarez, Bibiana Vargas Forero, Lynn Olson, Kristin Davis, Alexander Fiks, Miranda Griffith, Donna Harris, Everly Macario, Jennifer Steffes, Alessandra Torres, Rangaraj Selvarangan, Dithi Banerjee, Chris Day, Kelsye Howell, Megan Mains, Juan C. Salazar, William T. Zempsky, Emily Bean, Carlie DeFelice, Hassan El Chebib, Katherine W. Herbst, Stephanie Lesmes, Ian C. Michelow, Melissa Santos, Noah Schulman, Wilson D. Pace, Alicia Brooks-Greien, Karinne Colin, Christina M. Hester, Ariadna Juarez-Colunga, Brian Manning, Joel Shields, Jack Westfall, Daphne York, Judy Aschner, Katharine Clouser, Justine Griswold, Donna Lee, Amanda Nowakowski, Maryellen Riordan, Hulya Bukulmez, David Kaelber, Rozina Aamir, Mohammed Abuzahrieh, Nandini Bangalore, Alexis Brown, Wendy Dalton, Suzanne Fortuna, Judi Minium, Bonnie Rosolowski, Sheila M. Nolan, Amal Ahmed, Suzanne Braniecki, Montserrat Contreras, Allen Dozor, Supriya Jain, Suzanne Kaseta, Sankaran Krishnan, Zachary Messer, Armando Ramirez, Aalok Singh, Randy Williams, Kyung Rhee, Kelan Tantisira, Almary Akerlundh, Natacha Akshoomoff, Maria Arroyo, Wendy Barrientos, Rakesh Bhattacharjee, Bryant Y. Chao, Maricela Diaz, Sergio Garcia, Sonia Garcia, Guadalupe Gomez, Trinidad Herrera, Margarita Holguin, Manaswitha Khare, Elizabeth Kiernan, Jeremy Landeo Gutierrez, Ileana Matta, Sofia Reyes, Cinthia Sanchez, Andrea Schreck, Megan R. Warner, Uzma Hasan, Elizabeth Ricciardi, Vanessa Trespalacios, Vince Faustino, Matthew Kluko, Bryant Chao, Maria Glenn-Arroyo, Elizabeth A. Kiernan, Anika Madan, Lisa Ramos Vallejo, Cinthia E. Sanchez, Maira Suarez, Patricia Kinser, Amy Salisbury, Jocelyn Espinoza, Sara Moyer, Amy Rider, Sally Russell, Michael Schecter, Lindsey Stevenson, Cheryl R. Stein, Stephanie V. Caldas, Thomas Dylan Castro Ovalle, Anthony Chung, Jonathan S. Farkas, Maria Isidoro-Chino, Deniz Kesebir, Eugenia Kim, Ashley Quarless, Alan Schlechter, Ranjini Srinivasan, Viren D'Sa, Fatoumata Barry, Phoebe Burton, Rosa Cano Lorente, Caroline Cummins, Stephanie Wehbe, Sandra Brown, Anders Dale, Terry Jernigan, Susan Tapert, Jose Aguilar, David Benjamin, Natalie C. Buchbinder, Norma Castro, Brandy Emerson, Hugh Garavan, Jennifer Graves, Amanda Guerrero, Janosch Linkersdoerfer, Robert Schooley, Wes Thompson, Thanh Trinh, Ron Yang, Megan Herting, Elizabeth Sowell, Cynthia Cisneros, Lauren Goedde, Cedric Manlhiot, Raul Gonzalez, Angela Laird, Jorge Limia, Robin Aupperle, Martin Paulus, Melanie Curry, Nour S. El-Sabbagh, Kevin Gray, Lindsay Squeglia, Samuel Agbeh, Cori Herring, Brittany Mckenzie, Bonnie Nagel, Abby Espinoza, Anthony Hill, Angie Morales, Fiona Baker, Eva Muller-Oehring, Ian Colrain, Ingrid Durley, Mirella Dapretto, Lucina Uddin, Susan Bookheimer, Christina Caldera, Jennifer Dzul, Cinthia Zarate, Marie Banich, Paola Badilla, Jennifer Keith, G. Kumar, David Messinger, Katie Prazak, Sara Jo Nixon, Melanie Cardoso, Meagan Sullivan, Stephen Villard, Linda Chang, Thomas Ernst, Christine Cloak, Huajun Liang, Meghann C. Ryan, Mary Heitzerg, Jennifer Conley, Leonard Puttler, Monica Luciana, William Iacono, Aaron Schroeder, Duncan Clark, Doyeon (Dan) Kim, Megan Retucci, Edward Freedman, John Foxe, Sile Ni Mhurchu, Samantha Spallina, Erin McGlade, Deborah Yurgelun-Todd, Liz Bell, Kirsten Cline, Lauren Heinrich, Perry Renshaw, Alexandra Potter, Cass Barrett, Sofia Lozon, Samantha Spear, Christine Larson, Krista Lisdahl, Tory Clearwater, Christine Kaiver, Caitlin Nelson, Zach Paltzer, Bridgette Peteet, James Bjork, Mike Neale, Olive Calonge, Noah Slattery, Lisa Straub, Deanna Barch, Andrew Heath, Pamela Madden, Taylor Powell, Denise Schmitz, Dylan Gee, Boris Epie, Rebekah Hobbs, Alex Williams, Zhouran (Rick) Xiang, Julie Miller, Jane Newburger, Felicia Trachtenberg, Ayesha Amarnath, James Ambrosoli, Denise Artis, Sachin Bandari, Emily Birmingham, Lozan Eyob, Kerri Hayes, Chenwei Hu, Melissa Joyce, Valentina Kazlova, Iris Liu, Amanda Marshall, Devine Mbizdenyuy, P.J. Mu, Robin Rowe, Brooke Sayles, Mo Zhang, Pei-Ni Jone, Michael Carr, Lauren Goodell, Wantanabe Kar, Kathleen Van't Hof, Kristin Sexson, Elias Moussi, David Olukayode, Sandra Pena, Ricardo Pignatelli, Faridis Serrano, Sara Sexson Tejtel, Lara Shekerdemian, Audrey Dionne, Annette Baker, Sarah DeFerrantini, Thomas Giorgio, Numaira Khan, Simran Mahanta, MaryBeth Son, Matt Oster, Melissa Burnett, Kolby Sanders-Lewis, Sonia Chavez, Georgia Reis, Jackie Szmuszkovicz, Fariborz Behzadian, Carla Canas, Andrew Cheng, Mike Gawad, Paige Johnson, Alicia Kazarians, Anastasia Sarkissian, Brandi Scott, Consuelo Secules, Jennifer Su, Crystal Vargas, Jodie Votava-Smith, Sharon Wagner-Lees, Shuo Wang, Pierre Wong, Yamuna Sanil, Sanjeev Aggarwal, Aiman Almasnaah, Nirupama Kannikeswaran, Kathleen Meert, Gautam Singh, Priya Spencer, Nancy Sullivan, Sureja Sundaralingam, Vishnu Undyala, Emily Ward, Amanda Weber, Charmaine Williams Farr, Tamara Bradford, Marla Johnston, Matthew Elias, Alex Fiks, Chris Forrest, Dana Albizem, Susan Coffin, Therese Giglia, Katherine Lupton, Grace Marks, Tonia Morrison, Shawn O'Connor, Daniel Forsha, Jennifer Nelson, Rachel Sachdeva, Dara Watkins, Ashraf S. Harahsheh, Jordyn Britton, Alix Fetch, Anita Krishnan, Onais Tariq, Sean Lang, Marisa Almaguer, Jim Cnota, Lauryn Dugan, Elise Pickering, Kathleen Rathge, Elizabeth Mitchell, Christine Capone, Nilanjana Misra, Olga Shamailova, Mark Russell, Tammy Doman, Lori Harris, Keren Hasbani, Sagar Jani, Brian McCrindle, Jessica Bainton, Maryanne Chrisant, Doris Alaby, Norma Barton, Danielle Katz, Paulette Smith, Stephanie Handler, Joe Block, Regina Cole, Jennifer Maldonado, Kim McHugh, Andrew Atz, Megan Bickford, Jason Buckley, John Costello, Delany Dennis, Elizabeth Emrath-Zwick, Mary Freeman, Lanier Jackson, Madison Johnson, Elizabeth Mack, Scott Pletzer, Natasha Ruth, Carolyn Taylor, Sinai Zyblewski, Katrina Golub, Chanel Rojas, Korsin Rosalind, Chantal Sanchez, Shubhika Srivastava, Carol Prospero, Ed Williams, Varsha Zadokar, Arash Sabati, Kylie Domian, Ashley Herzberg, Sanjana Khanna, Todd Nowlen, Susan Park, Jade Porche, Samantha Stack, Dongngan Truong, Andrea Dunn, Lilly Fagatele, Emma Joyce, Linda Lambert, Kirsten Dummer, Sherrie Bandy, Jane Burns, Katheryn Crane, Sanjeet Hedge, Joan Pancheri, Adriana Tremoulet, Ronald Mark Payne, Mary Stumpf, Michael Portman, Hidemi Kajimoto, Camden Hebson, Krissie Hock, Onyekachukwu Osakwe, Jemylle Morato, Divya Shakti, Matt Kadish, Kavita Sharma, William Anguiano, Catherine Ikemba, Alejandra Lozano, Maria Martinez, Wendy Rojas, Lerraughn Morgan, Isaura Macias, Carl Owada, Mayra Rangel, and Michelle Sykes

Subjects
PEDSnet, PCORnet, Long COVID, Chronic COVID-19 syndrome, Late sequelae of COVID-19, Long-haul COVID, Medicine (General), R5-920
Abstract

Summary: Background: Children from racial and ethnic minority groups are at greater risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, but it is unclear whether they have increased risk for post-acute sequelae of SARS-CoV-2 (PASC). Our objectives were to assess whether the risk of respiratory and neurologic PASC differs by race/ethnicity and social drivers of health. Methods: We conducted a retrospective cohort study of individuals

Published
2025
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2. Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trialResearch in context

Author

Teresa H. Evering, Carlee Moser, Nikolaus Jilg, Justin Ritz, David A. Wohl, Jonathan Z. Li, David Margolis, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Eric S. Daar, Davey M. Smith, Michael D. Hughes, Kara W. Chew, Kara Chew, David (Davey) Smith, Eric Daar, David Wohl, Judith Currier, Joseph Eron, Michael Hughes, Mark Giganti, Lara Hosey, Jhoanna Roa, Nilam Patel, Kelly Colsh, Irene Rwakazina, Justine Beck, Scott Sieg, Jonathan Li, Courtney Fletcher, William Fischer, Rachel Bender Ignacio, Sandra Cardoso, Katya Corado, Prasanna Jagannathan, Alan Perelson, Sandy Pillay, Cynthia Riviere, Upinder Singh, Babafemi Taiwo, Joan Gottesman, Matthew Newell, Susan Pedersen, Joan Dragavon, Cheryl Jennings, Brian Greenfelder, William Murtaugh, Jan Kosmyna, Morgan Gapara, Akbar Shahkolahi, Verónica Lacal, Diego Salusso, Sebastian Nuñez, Marcelo Rodrigo Rodriguez, Luciana Laborde, Marcelo Papasidero, Luis Wehbe, Mariana Gonzalez, Felicitas Fernandez Voena, Tomas Alvarez, Amaru Lopez, Virginia Huhn, Ulises D'Andrea Nores, Pablo Dieser, Fernando Bordese, Marisa Mussi, Rodrigo de Carvalho Santana, Adriana Aparecida Tiraboschi Bárbaro, Breno Santos, Rita de Cássia Alves Lira, Andre Luiz Machado da Silva, Sandra Wagner Cardoso, Maria Pia Diniz Ribeiro, Nathália Soliva, Eduardo Vasconcellos, Jorge Eurico Ribeiro, Miriam Amaral Enéas, Jorge Pinto, Julia Fonseca de Morais Caporali, Flávia Gomes Faleiro Ferreira, Norma Erendira Rivera Martinez, Victor Casildo Bohorquez Lopez, Melchor Victor Frias, Krystle Fetalvero, Alyxzza Maranan, Jennifer Rosa, Thomas Coetzer, Maureen Mohata, Sr., Umesh Lalloo, Penelope Madlala, Larisha Pillay-Ramaya, Jaclyn Ann Bennet, Noluthando Mwelase, Nokuphiwa Mbhele, Frederick Petrick, Leonard Joubert, Rose Mbali, Sr., Natasha Joseph, Mmatsie Manentsa, Eugene van der Walt, Mduduzi Sandile Lawrance Masilela, Zinhle Zwane, Tendai Chiperera, Lerato Mohapi, Suri Moonsamy, Usha Singh, Kirsten McHarry, Elizma Snyman, Pieter Lennox, James Craig Innes, Oteng Letlape, Olebogeng Jonkane, William Brumskine, Tania Adonis, Ni Ni Sein, Modulakgotla Sebe, Yacoob Vahed, Nazreen Jeewa Hussen, Ismail Mitha, Vasundhara Cheekati, Purna Cheekati, Christie Lummus, Samuel Idarraga, Andrew Kim, David N. Pham, Wei-Hsin Kao, Michael M. Pfeffer, Miriam Batule Dominguez, Anju Malik, Anna Bryan, Melanie Arnold, Idania Fernandez, Cinzia Karpf, Aniuska Ruiz, David Taylor, Eric Folkens, Jennifer Manne, Sigal Yawetz, Cheryl Keenan, Emeka Eziri, Carl Fichtenbaum, Jenifer Baer, Sarah Trentman, Robert Call, Leroy Vaughan, Aaron Milstone, Jamie Alex Slandzicki, Jessica Wallan, Clinton Guillory, Nancy Andrews, Leslie Hughes, Jonathan Berardi, Celine Arar, Randall Quinn, Jorge P. Amaya, Marissa Gomez-Martinez, Luis Cantu, Monica Betancourt-Garcia, Nwora Lance Okeke, Charles M. Burns, Fadi Haddad, Victoria Haddad, Augusto Focil, Griselda Rosas, Susana Moyano, Yaneicy Gonzalez Rojas, Ahmad Aswad, Yevgeniy Bukhman, Manish Jain, Eugene Bukhman, Humam Farah, Rebekah McClain, Sadia Shaik, Timothy Hatlen, Deepa Gotur, Joseph Surber, Jeffrey Kingsley, April Pixler, Alex Zopo, Jack Herman, Craig Herman, Ramon Leon, Boris Nikolov, Fernando Gonzalez Vergara, Ana I. Gonzalez, Noemi Gonzalez, Michael Gelman, Olga Andriunas, Zarema Jagizarov, Jan Westerman, David Davis, Donna Sherer, Kelly Dooley, Becky Becker, Adaliah Wilkins, Jose Pérez, Eloy Roman, Heriberto Fernández, Bharat Mocherla, Kelly Beck, Valarie Maldonado, Jennifer Veltman, Rajesh Gandhi, Katrina Shea, Matthew Planchon, Laura Bogan Herpel, Kaushlendra K. Tripathi, Donald C. Day, John Pullman, Sr., Erin Williams-Leber, Misty Johnson, Michelle Hecker, Ann Avery, Keila Hoover, George W. Monlux, Elizabeth Juneja, Jr., Arthur Wernick, Karelia Ruiz, Maureen Hernández, Yadilys Pérez, Babafemi O. Taiwo, Claudia Hawkins, Baiba Berzins, Carlos Malvestutto, Heather Harber, Robyn Cicarella, Edwin DeJesus, Charlotte-Paige Rolle, Almena L. Free, Sallie D. Pulliam, Debra Weinstein, Rosa M. Suarez, Ezequiel Socorro, Estefania Socorro, Gene Neytman, Raymond Easley, Mariam Aziz, Joan Swiatek, Avish Nagpal, Breanna Kompelien, Kathryn McEvoy, Susan E. Hoover, Allison Lutz, Jessica Just, Manuel Hernandez, Yanly B. Victoria, Gabriel Rodriguez, Divya Pathak, Joshua J. Ordway, Megan Heffner, Patrick Weston, Khalilah Weston, Madhu Choudhary, Jennifer Sullivano, Olayemi Osiyemi, Myriam Izquierdo, Odelsey Torna, Brian Clemency, Renoj Varughese, Joshua Lynch, Aleen Khodabakhshian, Samantha Fortier, Christopher Coyne, Alexandrea Cronin, Constance Benson, Steven Hendrickx, Rosemarie Ramirez, Anne Luetkemeyer, Suzanne Hendler, Dennis Dentoni-Lasofsky, Mobeen Rathore, Saniyyah Mahmoudi, Amna Riaz, Mario Castro, Leslie Spikes, Chase Hall, Jonathan Oakes, Amy James Loftis, Pablo Tebas, William Short, Michael P. Dube, Saahir Khan, Luis M. Mendez, Sarah McGuffin, Chris Jonsson, Mamta K. Jain, Smruthi Senthil, Kimberly Turner-Gray, Sanjay Mehta, Mary Lewinski, Masoud Azizad, Christopher Chow, Lisa Nakatani, Derrick Williamson, Hisham Atriss, Matthew Caloura, Midhun Malla, Hannah Hazard-Jenkins, Aimee Wilkin, Jamraus Fayssoux, Hannah Seagle, Rachel Presti, and Alem Haile

Subjects
COVID-19, Monoclonal antibodies, Outpatient treatment, Clinical trial, Post COVID conditions, Long COVID, Medicine (General), R5-920
Abstract

Summary: Background: It is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID. Methods: Non-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo. Findings: Participants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53–0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID. Interpretation: Amubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID. Funding: National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.

Published
2024
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3. Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trialResearch in context

Author

Prasanna Jagannathan, Kara W. Chew, Mark J. Giganti, Michael D. Hughes, Carlee Moser, Mark J. Main, Phillip D. Monk, Arzhang Cyrus Javan, Jonathan Z. Li, Courtney V. Fletcher, Caitlyn McCarthy, David A. Wohl, Eric S. Daar, Joseph J. Eron, Judith S. Currier, Upinder Singh, Davey M. Smith, William Fischer, Kara Chew, David (Davey) Smith, Eric Daar, David Wohl, Judith Currier, Joseph Eron, Michael Hughes, Mark Giganti, Justin Ritz, Lara Hosey, Jhoanna Roa, Nilam Patel, Kelly Colsh, Irene Rwakazina, Justine Beck, Scott Sieg, Jonathan Li, Courtney Fletcher, Teresa Evering, Rachel Bender Ignacio, Sandra Cardoso, Katya Corado, Nikolaus Jilg, Alan Perelson, Sandy Pillay, Cynthia Riviere, Babafemi Taiwo, Joan Gottesman, Matthew Newell, Susan Pedersen, Joan Dragavon, Cheryl Jennings, Brian Greenfelder, William Murtaugh, Jan Kosmyna, Morgan Gapara, Akbar Shahkolahi, Gerald Pierone, Juliana Elliott, Jeffrey Jacobson, Leila Hojat, Julie Pasternak, Jonathan Berardi, Celine Arar, Yevgeniy Bukhman, Manish Jain, Eugene Bukhman, Sadia Shaik, Timothy Hatlen, Kelly Dooley, Becky Becker, Adaliah Wilkins, Jose Pérez, Eloy Roman, Heriberto Fernández, Keila Hoover, James Renfroe, Mauney Weldon, Genei Bougher, Carlos Malvestutto, Heather Harber, Robyn Cicarella, Gene Neytman, Jack Herman, Craig Herman, Mariam Aziz, Joan Swiatek, Divya Pathak, Madhu Choudhary, Jennifer Sullivano, Olayemi Osiyemi, Myriam Izquierdo, Odelsey Torna, Aleen Khodabakhshian, Samantha Fortier, Constance Benson, Steven Hendrickx, Rosemarie Ramirez, Anne Luetkemeyer, Suzanne Hendler, Dennis Dentoni-Lasofsky, Mario Castro, Leslie Spikes, Chase Hall, Jonathan Oakes, Amy James Loftis, Pablo Tebas, William Short, Sarah McGuffin, Chris Jonsson, Rachel Presti, and Alem Haile

Subjects
Inhaled interferon, SARS-CoV-2, COVID-19, ACTIV-2, Randomized clinical trial, Medicine (General), R5-920
Abstract

Summary: Background: With the emergence of SARS-CoV-2 variants resistant to monoclonal antibody therapies and limited global access to therapeutics, the evaluation of novel therapeutics to prevent progression to severe COVID-19 remains a critical need. Methods: Safety, clinical and antiviral efficacy of inhaled interferon-β1a (SNG001) were evaluated in a phase II randomized controlled trial on the ACTIV-2/A5401 platform (ClinicalTrials.gov NCT04518410). Adult outpatients with confirmed SARS-CoV-2 infection within 10 days of symptom onset were randomized and initiated either orally inhaled nebulized SNG001 given once daily for 14 days (n = 110) or blinded pooled placebo (n = 110) between February 10 and August 18, 2021. Findings: The proportion of participants reporting premature treatment discontinuation was 9% among SNG001 and 13% among placebo participants. There were no differences between participants who received SNG001 or placebo in the primary outcomes of treatment emergent Grade 3 or higher adverse events (3.6% and 8.2%, respectively), time to symptom improvement (median 13 and 9 days, respectively), or proportion with unquantifiable nasopharyngeal SARS-CoV-2 RNA at days 3 (28% [26/93] vs. 39% [37/94], respectively), 7 (65% [60/93] vs. 66% [62/94]) and 14 (91% [86/95] vs. 91% [83/81]). There were fewer hospitalizations with SNG001 (n = 1; 1%) compared with placebo (n = 7; 6%), representing an 86% relative risk reduction (p = 0.07). There were no deaths in either arm. Interpretation: In this trial, SNG001 was safe and associated with a non-statistically significant decrease in hospitalization for COVID-19 pneumonia. Funding: The ACTIV-2 platform study is funded by the NIH. Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1 AI068634, UM1 AI068636 and UM1 AI106701. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published
2023
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4. An interactive mobile application versus an educational booklet to promote job retention in women undergoing adjuvant chemotherapy for breast cancer: a randomized controlled trial

Author

Victoria S. Blinder, Sujata Patil, Jackie Finik, Della Makower, Monica Muppidi, Wendy G. Lichtenthal, Patricia A. Parker, Maria Claros, Jennifer Suarez, Bharat Narang, and Francesca Gany

Subjects
Employment, Breast cancer, Disparities, Minority, Income, Cancer survivorship, Medicine (General), R5-920
Abstract

Abstract Background Job loss after a cancer diagnosis can lead to long-term financial toxicity and its attendant adverse clinical consequences, including decreased treatment adherence. Among women undergoing (neo)adjuvant chemotherapy for breast cancer, access to work accommodations (e.g., sick leave) is associated with higher job retention after treatment completion. However, low-income and/or minority women are less likely to have access to work accommodations and, therefore, are at higher risk of job loss. Given the time and transportation barriers that low-income working patients commonly face, it is crucial to develop an intervention that is convenient and easy to use. Methods We designed an intervention to promote job retention during and after (neo)adjuvant chemotherapy for breast cancer by improving access to relevant accommodations. Talking to Employers And Medical staff about Work (TEAMWork) is an English/Spanish mobile application (app) that provides (1) suggestions for work accommodations tailored to specific job demands, (2) coaching/strategies for negotiating with an employer, (3) advice for symptom self-management, and (4) tools to improve communication with the medical oncology team. This study is a randomized controlled trial to evaluate the app as a job-retention tool compared to a control condition that provides the app content in an informational paper booklet. The primary outcome of the study is work status after treatment completion. Secondary outcomes include work status 1 and 2 years later, participant self-efficacy to ask an employer for accommodations, receipt of workplace accommodations during and following adjuvant therapy, patient self-efficacy to communicate with the oncology provider, self-reported symptom burden during and following adjuvant therapy, and cancer treatment adherence. Discussion This study will assess the use of mobile technology to improve vulnerable breast cancer patients’ ability to communicate with their employers and oncology providers, work during treatment and retain their jobs in the long term, thereby diminishing the potential consequences of job loss, including decreased treatment adherence, debt, and bankruptcy. Trial registration ClincalTrials.gov NCT03572374 . Registered on 08 June 2018.

Published
2022
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5. Effect of Carrots (Daucus carota L.) on Gastric Histopathology of Piroxicam-Induced Mice as a Peptic Ulcer Prevention

Author

Jennifer Susanto, Danti Nur Indiastuti, and Gondo Mastutik

Subjects
carrot, famotidine, health risk, peptic ulcer, piroxicam, Medicine (General), R5-920
Abstract

Highlights: 1. Carrots (Daucus carota L.) can reduce the side effects of non-steroidal anti-inflammatory drugs (NSAIDs) due to its gastroprotective components. 2. Histopathological studies of the gastric inflammation signs showed that carrots can prevent NSAID-induced peptic ulcers. Abstract Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) consumption contributes significantly to gastrointestinal morbidity, including peptic ulcers. NSAIDs cause gastric mucosal damage by inhibiting PGE2 and PGI2 secretion, increasing HCl secretion, and also causing local irritation and neutrophil adhesion. Flavonoids and chlorogenic acid are gastroprotective agents found in carrots (Daucus carota L.). Therefore, this study aimed to validate the effect of carrots on gastric histopathology of piroxicam-induced mice. Methods: This was an experimental study using a post-test-only control group design. 35 mice were divided into 5 groups and were allowed to adapt for 1 week. The negative control group received 0.25 mL aqua dest, while the positive control group received 0.104 mg famotidine. Group A, B, and C received carrot extract with each dosage was 200 mg/kgBW, 300 mg/kgBW, and 400 mg/kgBW. The mice were induced 2 hours later with 0.052 mg piroxicam. The treatments lasted 14 days. Each stomach was taken and examined on the 15th day. Afterward, histopathological preparations were made. Results: The results of the histopathological signs of inflammation using the Kruskal-Wallis method showed p = 0.000, indicating that there was an effect of the carrot extract in preventing the inflammation on the gastric histopathology (p < 0.05). Conclusion: In conclusion, this study confirmed that carrot extract is more effective in avoiding peptic ulcers due to NSAID consumption.

Published
2022
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6. Implementing an Integrated Generalist-Led Inpatient Care Model: Results of a Mixed-Method Evaluation

Author

Jennifer Sumner, Kimberly Teo, Cherylanne Tan, Sin Hui Neo, Lin Hui Lee, Brian Ng, and Yee Wei Lim

Subjects
hospital-based, chronic disease, health services research, implementation, Medicine (General), R5-920
Abstract

Introduction: Healthcare integration has become prevalent as health systems manage a growing population of older adults with multi-morbid conditions. The integrated general hospital (IGH) is the latest example of how services can be remodelled to achieve greater care integration. Methods: We conducted a mixed-method evaluation to identify factors impacting the implementation and effectiveness of the IGH model. Data were collected through in-depth interviews (n = 15) and focus group discussions (n = 8 groups) with hospital staff, and a staff survey (n = 226). Results: Staff perceived improvements in clinical practice and better clinical outcomes for patients. The care model empowered nursing and allied health staff through a more collegial team structure. However, staff reported an unequal workload distribution; a third reported burnout; and some observed inconsistencies between leaders’ aspirations for IGH and what was happening on the ground. For IGH to sustain, staff’s education on the IGH model needs to be improved. Further examination of work processes is recommended to boost staff morale and prevent burnout. Conclusion: Overall, IGH provided better integrated, team-based care. The model challenged traditional team structures and empowered staff to expand their roles and responsibilities. Policymakers could consider the IGH model a successful approach for integrating services across the care continuum.

Published
2023
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7. Early Changes and Indicators Characterizing Lung Aging in Neonatal Chronic Lung Disease

Author

Jennifer Sucre, Lena Haist, Charlotte E. Bolton, and Anne Hilgendorff

Subjects
neonatal chronic lung disease, bronchopulmonary dysplasia, lung aging, inflammation, mechanical ventilation, oxygen toxicity, Medicine (General), R5-920
Abstract

Infants suffering from neonatal chronic lung disease, i.e., bronchopulmonary dysplasia, are facing long-term consequences determined by individual genetic background, presence of infections, and postnatal treatment strategies such as mechanical ventilation and oxygen toxicity. The adverse effects provoked by these measures include inflammatory processes, oxidative stress, altered growth factor signaling, and remodeling of the extracellular matrix. Both, acute and long-term consequences are determined by the capacity of the immature lung to respond to the challenges outlined above. The subsequent impairment of lung growth translates into an altered trajectory of lung function later in life. Here, knowledge about second and third hit events provoked through environmental insults are of specific importance when advocating lifestyle recommendations to this patient population. A profound exchange between the different health care professionals involved is urgently needed and needs to consider disease origin while future monitoring and treatment strategies are developed.

Published
2021
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8. Sharing knowledge for policy action in low- and middle-income countries: A literature review of managed entry agreements

Author

Hector E. Castro, Tanya Malpica-Llanos, Ruth Musila, Niranjan Konduri, Ana Amaris, Jennifer Sullivan, and Colin Gilmartin

Subjects
Medicine (General), R5-920
Abstract

Managed entry agreements (MEAs)—a type of formal institutional arrangement between pharmaceutical companies and payers for sharing the risk with respect to the introduction of new pharmaceutical technologies—may expand access to new pharmaceutical technologies for non-communicable diseases (NCDs). Although common in highincome countries (HICs), there is limited evidence of their use in low- and middle-income countries (LMICs). This article aims to document international experiences of countries implementing MEAs and potential barriers and facilitators for their use in LMICs. We reviewed published literature sources on MEAs over the past 10 years considering peer-reviewed publications and gray literature data. We took into consideration the MEAs taxonomy presented by Kanavos and Ferrario et al. to categorize our findings, and extract information on factors for their implementation. We retrieved 285 MEAs documented in the literature, mostly from HICs and for a broad spectrum of NCDs. Financial schemes were slightly more prominent than performance-based agreements. Identified factors that could potentially facilitate or hinder the implementation of MEAs included the presence of quality administrative and information systems to track their implementation; availability of quality data and evidence of positive outcomes; uncertainty of drug efficacy/effectiveness, safety, and financial impact; and cultural factors, namely country’s preference for certain type of agreement and trust among payers and manufacturers. The increased availability of publications in recent years suggests a growing interest among policy-makers and researchers in the implementation of MEAs. While the use of MEAs in LMICs is very limited, this could be the result of limited empirical evidence on its use and possibly due to the use of a different taxonomy for describing MEAs in these settings. As any other policy option, the implementation and use of MEAs come with advantages and challenges. Since there is limited evidence on their use in LMICs, the identified cases of implementation in HICs may serve to inform the interest on MEAs in resource limited settings. Therefore, further research in this field especially in the context of LMICs may be of value for the global community as all countries are embarking into fairer and sustainable Universal Health Coverage (UHC).

Published
2019
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10. Evaluating a Health Care Partnership in Australia

Author

Jennifer Suzanne Reath, Penny Burns, Brogan Renshaw, Ron Brooker, Penelope Abbott, Walter Kmet, and Tim Usherwood

Subjects
health services, integration, evaluation, Medicine (General), R5-920
Published
2015

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