1. Post-acute sequelae of SARS-CoV-2 infection (PASC): a protocol for a multidisciplinary prospective observational evaluation of a cohort of patients surviving hospitalisation in Sao Paulo, Brazil
- Author
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Paulo A Lotufo, Juliana C Ferreira, Eloisa Bonfa, Marta Imamura, Roger Chammas, Thais Mauad, Izabel Marcilio, Nelson Gouveia, Anna Sara Levin, Bruno Fukelmann Guedes, Luiz Henrique Martins Castro, Ricardo Nitrini, José Eduardo Krieger, Geraldo Filho Busatto, Adriana Ladeira de Araújo, Alberto José da Silva Duarte, Esper Georges Kallas, Fabio Rezende Pinna, Heraldo Possolo de Souza, Katia Regina da Silva, Marcio Valente Yamada Sawamura, Marilia Seelaender, Michelle Louvaes Garcia, Orestes Vicente Forlenza, Rodolfo Furlan Damiano, Vanderson Geraldo Rocha, Linamara Rizzo Batisttella, Carlos Roberto Ribeiro de Carvalho, Claudia da Costa Leite, Cristiano Gomes, Emmanuel A. Burdmann, Euripedes C. Miguel, Giovanni G. Cerri, Guilherme Fonseca, Jorge Hallak, Luis Yu, Maria Cassia J Mendes Corrêa, Marcio Mancini, Maria Elizabeth Rossi, Ricardo Ferreira Bento, Rossana Pulcinelli Francisco, Thiago Avelino-Silva, Wilson Jacob Filho, Edivaldo M Utiyama, Aluisio C Segurado, Beatriz Perondi, Anna Miethke-Morais, Amanda C Montal, Leila Harima, Solange R G Fusco, Marjorie F Silva, Marcelo C Rocha, Izabel Cristina Rios, Fabiane Yumi Ogihara Kawano, Maria Amélia de Jesus, Carolina Carmo, Clarice Tanaka, Julio F M Marchini, Maura Salaroli Oliveira, Thaís Guimarães, Carolina dos Santos Lázari, Ester Sabino, Marcello MC Magri, Tarcisio E P Barros-Filho, and Maria Cristina Peres Braido Francisco
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medicine.medical_specialty ,Disease ,Epidemiology ,medicine ,Humans ,Research ethics ,business.industry ,SARS-CoV-2 ,COVID-19 ,rehabilitation medicine ,General Medicine ,Biobank ,Infectious Diseases ,Phobic Disorders ,Emergency medicine ,Cohort ,Medicine ,Biomarker (medicine) ,Observational Studies as Topic ,Observational study ,epidemiology ,business - Abstract
IntroductionCOVID-19 may lead to persistent and potentially incapacitating clinical manifestations (post-acute sequelae of SARS-CoV-2 infection (PASC)). Using easy-to-apply questionnaires and scales (often by telephone interviewing), several studies evaluated samples of COVID-19 inpatients from 4 weeks to several months after discharge. However, studies conducting systematic multidisciplinary assessments of PASC manifestations are scarce, with thorough in-person objective evaluations restricted to modestly sized subsamples presenting greatest disease severity.Methods and analysesWe will conduct a prospective observational study of surviving individuals (above 18 years of age) from a cohort of over 3000 subjects with laboratory-confirmed COVID-19 who were treated as inpatients at the largest academic health centre in Sao Paulo, Brazil (Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo). All eligible subjects will be consecutively invited to undergo a 1–2-day series of multidisciplinary assessments at 2 time-points, respectively, at 6–9 months and 12–15 months after discharge. Assessment schedules will include detailed multidomain questionnaires applied by medical research staff, self-report scales, objective evaluations of cardiopulmonary functioning, physical functionality and olfactory status, standardised neurological, psychiatric and cognitive examinations, as well as diagnostic laboratory, muscle ultrasound and chest imaging exams. Remaining material from blood tests will be incorporated by a local biobank for use in future investigations on inflammatory markers, genomics, transcriptomics, peptidomics and metabolomics.Ethics and disseminationAll components of this programme have been approved by local research ethics committees. We aim to provide insights into the frequency and severity of chronic/post-COVID multiorgan symptoms, as well as their interrelationships and associations with acute disease features, sociodemographic variables and environmental exposures. Findings will be disseminated in peer-reviewed journals and at scientific meetings. Additionally, we aim to provide a data repository to allow future pathophysiological investigations relating clinical PASC features to biomarker data extracted from blood samples.Trial registration numberRBR-8z7v5wc; Pre-results.
- Published
- 2021