Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19

Autor: Carla Romano, Sheri Fehnel, Jeffrey Stoddard, Jerald Sadoff, Sandy Lewis, Pauline McNulty, Eric K. H. Chan, Emily Evans, Carol Jamieson, Ashley F. Slagle, Allen Mangel, Kelly McQuarrie

Publikováno v: Journal of Patient-Reported Outcomes, Vol 6, Iss 1, Pp 1-12 (2022)

Abstract Background Given the urgent need for vaccines and treatments for coronavirus disease 2019 (COVID-19), the Symptoms of Infection with Coronavirus-19 (SIC), a comprehensive, patient-reported outcome (PRO) measure of signs and symptoms associat

Externí odkaz: https://doaj.org/article/cab0cbcd99a148568acf949b57f3f9da

Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial

Autor: Karin Hardt, An Vandebosch, Jerald Sadoff, Mathieu Le Gars, Carla Truyers, David Lowson, Ilse Van Dromme, Johan Vingerhoets, Tobias Kamphuis, Gert Scheper, Javier Ruiz-Guiñazú, Saul N Faust, Christoph D Spinner, Hanneke Schuitemaker, Johan Van Hoof, Macaya Douoguih, Frank Struyf, Brian T. Garibaldi, Timothy E. Albertson, Christian Sandrock, Janet S. Lee, Mark R. Looney, Victor F. Tapson, Charles Shey Wiysonge, Luis Humberto Anaya Velarde, Daniel Backenroth, Jisha Bhushanan, Börries Brandenburg, Vicky Cárdenas, Bohang Chen, Fei Chen, Polan Chetty, Pei-Ling Chu, Kimberly Cooper, Jerome Custers, Hilde Delanghe, Anna Duca, Tracy Henrick, Jarek Juraszek, Catherine Nalpas, Monika Peeters, Jose Pinheiro, Sanne Roels, Martin F. Ryser, Jose Salas, Samantha Santoro Matias, Ilse Scheys, Pallavi Shetty, Georgi Shukarev, Jeffrey Stoddard, Willem Talloen, NamPhuong Tran, Nathalie Vaissiere, Elisabeth van Son-Palmen, Jiajun Xu, Erin A. Goecker, Alexander L. Greninger, Keith R. Jerome, Pavitra Roychoudhury, Simbarashe G. Takuva, Jose Luis Accini Mendoza, Eric Achtyes, Habibul Ahsan, Azhar Alhatemi, Nancy Allen, Jose R. Arribas, Ghazaleh Bahrami, Lucia Bailon, Ali Bajwa, Jonathan Baker, Mira Baron, Susana Benet, Driss Berdaï, Patrick Berger, Todd Bertoch, Claire Bethune, Sybille Bevilacqua, Maria Silvia Biagioni Santos, Ian Binnian, Karen Bisnauthsing, Jean-Marc Boivin, Hilde Bollen, Sandrine Bonnet, Alberto M. Borobia, Elisabeth Botelho-Nevers, Phil Bright, Vianne Britten, Claire Brown, Amanda Buadi, Erik Buntinx, Lesley Burgess, Larry Bush, Maria Rosario Capeding, Quito Osuna Carr, Amparo Carrasco Mas, Hélène Catala, Katrina Cathie, T. Shawn Caudill, Fernando Cereto Castro, Kénora Chau, Steven Chavoustie, Marie Chowdhury, Nicolas Chronos, Paola Cicconi, Liliana Cifuentes, Sara Maria Cobo, Helen Collins, Hayley Colton, Carlos Rolando G. Cuaño, Valentino D'Onofrio, Paul Dargan, Thomas Darton, Peter Deane, Jose Luis Del Pozo, Inge Derdelinckx, Amisha Desai, Michael Dever, Beatriz Díaz-Pollán, Mark DiBuono, Matthew Doust, Christopher Duncan, Jose Maria Echave-Sustaeta, Frank Eder, Kimberly Ellis, Stanton Elzi, Stevan Emmett, Johannes Engelbrecht, Mim Evans, Theo Farah, Timothy Felton, João Pedro Ferreira, Catherine Floutier, Patrick Flume, Stacy Ford, Veronica Fragoso, Andrew Freedman, Emilia Frentiu, Christopher Galloway, Florence Galtier, Julia Garcia Diaz, Irene García García, Alcaide Garcia, Zoe Gardener, Pascale Gauteul, Steven Geller, Andrew Gibson, Claudia Gillet, Nicolas Girerd, Pierre-Olivier Girodet, Maria Tarcela Gler, Richard Glover, Herschel Don D. Go, Karishma Gokani, Damien Gonthier, Christopher Green, Richard Greenberg, Carl Griffin, Coert Grobbelaar, Adonis Guancia, Gloria Hakkarainen, James Harris, Michael Hassman, Deirdre Heimer, Elizabeth Hellstrom-Louw, Yoan Herades, Christopher Holroyd, Nazreen Hussen, Marie Grace Dawn Isidro, Yvonne Jackson, Manish Jain, Esaú Custódio João Filho, Daniel Johnson, Ben Jones, Natasha Joseph, Analyn Jumeras, Patricia Junquera, Johanna Kellett-Wright, Patrick Kennedy, Paul E. Kilgore, Kenneth Kim, Murray Kimmel, George Konis, Mark Kutner, Karine Lacombe, Odile Launay, Rajeka Lazarus, Samuel Lederman, Gigi Lefebvre, Katrina Lennon Collins, Isabel Leroux-Roels, Kenneth Wilson O. Lim, Muriel Lins, Edward Liu, Martin Llewelyn, Akbar Mahomed, Bernardo Porto Maia, Alícia Marín-Candon, Xavier Martínez-Gómez, Jean Benoit Martinot, Andrea Mazzella, Frank McCaughan, Louise McCormack, John McGettigan, Purvi Mehra, Rhonda Mejeur, Vicki Miller, Anthony Mills, Jose Molto Marhuenda, Prebashan Moodley, Marta Mora-Rillo, Beatriz Mothe, Daniel Mullan, Alasdair Munro, Paul Myers, Jeremy Nell, Tamara Newman Lobato Souza, Jane A. O'Halloran, Maria Dolores Ochoa Mazarro, Abigail Oliver, Jose Millan Onate Gutierrez, Jessica Ortega, Masaru Oshita, Susana Otero Romero, Jeffrey Scott Overcash, Daniel Owens, Alice Packham, Mihaela Pacurar, Leonardo Paiva de Sousa, Adrian Palfreeman, Christian José Pallares, Rahul Patel, Suchet Patel, Leslie Pelkey, Denise Peluso, Florentina Penciu, S. Jerry Pinto, Kevin Pounds, Joe Pouzar, Antoinette Pragalos, Rachel Presti, David Price, Ehsaan Qureshi, José Valdez Ramalho Madruga, Mayur Ramesh, Bruce Rankin, Béatrice Razat, Breno Riegel Santos, Robert Riesenberg, Ernie Riffer, Siobhan Roche, Katie Rose, Pietro Rosellini, Patrick Rossignol, Beth Safirstein, Hernan Salazar, Gregorio Sanchez Vallejo, Smrithi Santhosh, Enrique Seco-Meseguer, Michael Seep, Emma Sherry, Philip Short, Patrick Soentjens, Joel Solis, Alejandro Soriano Viladomiu, Caroline Sorli, Selwyn Spangenthal, Niamh Spence, Elaine Stephenson, Cynthia Strout, Ronald Surowitz, Kristy Michelle Taladua, David Tellalian, Claire Thalamas, Nang Thiriphoo, Judith Thomas, Nicholas Thomas, Guillermo Trout, Mikel Urroz, Bernard Veekmans, Laurent Veekmans, Ralph Elvi M. Villalobos, Sarah Warren, Brian Webster, Alexander White, Gail Williams, Hayes Williams, Barbara Wilson, Alan Winston, Martin Wiselka, Marcus Zervos

Publikováno v: The Lancet Infectious Diseases. 22:1703-1715

Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and imm

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::07f798572b21f13734646bce589e2214
https://doi.org/10.1016/s1473-3099(22)00506-0

1069. Psychometric Properties of the Symptoms of Infection with Coronavirus-19: A Patient-Reported Outcome Measure for COVID-19 Signs and Symptoms

Autor: Eric K H Chan, Jeffrey Stoddard, Jerald Sadoff, Yan Liu, Ilse van Dromme, Eva G Katz, Yi-hsuan Liu, Kelly McQuarrie

Publikováno v: Open Forum Infectious Diseases. 9

Background The Symptoms of Infection with Coronavirus-19 (SIC), a patient reported outcome (PRO) measure, was developed to assess COVID-19 signs and symptoms. Qualitative and cross-sectional studies demonstrated its content validity and preliminary p

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::42124bfacfae9c02aa066e7e4a5c889a
https://doi.org/10.1093/ofid/ofac492.910

Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19

Autor: Jerald, Sadoff, Glenda, Gray, An, Vandebosch, Vicky, Cárdenas, Georgi, Shukarev, Beatriz, Grinsztejn, Paul A, Goepfert, Carla, Truyers, Hein, Fennema, Bart, Spiessens, Kim, Offergeld, Gert, Scheper, Kimberly L, Taylor, Merlin L, Robb, John, Treanor, Dan H, Barouch, Jeffrey, Stoddard, Martin F, Ryser, Mary A, Marovich, Kathleen M, Neuzil, Lawrence, Corey, Nancy, Cauwenberghs, Tamzin, Tanner, Karin, Hardt, Javier, Ruiz-Guiñazú, Mathieu, Le Gars, Hanneke, Schuitemaker, Johan, Van Hoof, Frank, Struyf, Macaya, Douoguih, Marcus, Zervos

Publikováno v: New England Journal of Medicine. 384:2187-2201

The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation.In an internation

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee15932e9c6292bf57ca0d0bf206bc00
https://doi.org/10.1056/nejmoa2101544

Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19

Autor: Carla Romano, Sheri Fehnel, Jeffrey Stoddard, Jerald Sadoff, Sandy Lewis, Pauline McNulty, Eric K. H. Chan, Emily Evans, Carol Jamieson, Ashley F. Slagle, Allen Mangel, Kelly McQuarrie

Publikováno v: Journal of patient-reported outcomes. 6(1)

Background Given the urgent need for vaccines and treatments for coronavirus disease 2019 (COVID-19), the Symptoms of Infection with Coronavirus-19 (SIC), a comprehensive, patient-reported outcome (PRO) measure of signs and symptoms associated with C

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b3a872642d8031e612ab49e8044772e
https://pubmed.ncbi.nlm.nih.gov/35904710