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. Issue 6 (30th June 2021)

• Record Type: Journal Article
• Authors: Busatto, Geraldo Filho; de Araújo, Adriana Ladeira; Duarte, Alberto José da Silva; Levin, Anna Sara; Guedes, Bruno Fukelmann; Kallas, Esper Georges; Pinna, Fabio Rezende; de Souza, Heraldo Possolo; da Silva, Katia Regina; Sawamura, Marcio Valente Yamada; Seelaender, Marilia; Imamura, Marta; Garcia, Michelle Louvaes; Forlenza, Orestes Vicente; Nitrini, Ricardo; Damiano, Rodolfo Furlan; Rocha, Vanderson Geraldo; Batisttella, Linamara Rizzo; Carvalho, Carlos Roberto Ribeiro de
• Other Names: author non-byline.; Leite Claudia da Costa author non-byline.; Gomes Cristiano author non-byline.; Burdmann Emmanuel A. author non-byline.; Miguel Euripedes C. author non-byline.; Cerri Giovanni G. author non-byline.; Fonseca Guilherme author non-byline.; Hallak Jorge author non-byline.; Krieger José Eduardo author non-byline.; Yu Luis author non-byline.; Castro Luiz Henrique Martins author non-byline.; J Mendes Corrêa Maria Cassia author non-byline.; Mancini Marcio author non-byline.; Rossi Maria Elizabeth author non-byline.; Gouveia Nelson author non-byline.; Lotufo Paulo A author non-byline.; Bento Ricardo Ferreira author non-byline.; Chammas Roger author non-byline.; Francisco Rossana Pulcinelli author non-byline.; Mauad Thais author non-byline.; Avelino-Silva Thiago author non-byline.; Filho Wilson Jacob author non-byline.; author non-byline.; Bonfá Eloisa author non-byline.; Utiyama Edivaldo M author non-byline.; Segurado Aluisio C author non-byline.; Perondi Beatriz author non-byline.; Miethke-Morais Anna author non-byline.; Montal Amanda C author non-byline.; Harima Leila author non-byline.; Fusco Solange R G author non-byline.; Silva Marjorie F author non-byline.; Rocha Marcelo C author non-byline.; Marcilio Izabel author non-byline.; Rios Izabel Cristina author non-byline.; Kawano Fabiane Yumi Ogihara author non-byline.; de Jesus Maria Amélia author non-byline.; Carmo Carolina author non-byline.; Tanaka Clarice author non-byline.; Marchini Julio F M author non-byline.; Ferreira Juliana C author non-byline.; Oliveira Maura Salaroli author non-byline.; Guimarães Thaís author non-byline.; Lázari Carolina dos Santos author non-byline.; Sabino Ester author non-byline.; Magri Marcello MC author non-byline.; Barros-Filho Tarcisio E P author non-byline.; Peres Braido Francisco Maria Cristina author non-byline.;
• Is Part Of: BMJ open. Volume 11:Issue 6(2021)
• Publication Date: 2021-06-30
• Subjects: COVID-19 -- epidemiology -- rehabilitation medicine; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-051706
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: COVID-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 analyses: We 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 dissemination: All 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 number: RBR-8z7v5wc; Pre-results.