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
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 w...
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2021-06-01
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| author | 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 Maria Cristina Peres Braido Francisco |
| author_facet | 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 Maria Cristina Peres Braido Francisco |
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| description | 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. |
| format | Article |
| id | doaj-art-d9849062c6c24f049adb87e3de17bd6c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d9849062c6c24f049adb87e3de17bd6c2024-11-19T18:05:10ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111610.1136/bmjopen-2021-051706Post-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 0Paulo A LotufoJuliana C FerreiraEloisa Bonfa1Marta Imamura2Roger ChammasThais MauadIzabel MarcilioNelson Gouveia3Anna Sara Levin4Bruno Fukelmann Guedes5Luiz Henrique Martins CastroRicardo Nitrini6José Eduardo KriegerGeraldo Filho Busatto7Adriana Ladeira de Araújo8Alberto José da Silva Duarte9Esper Georges Kallas10Fabio Rezende Pinna11Heraldo Possolo de Souza12Katia Regina da Silva13Marcio Valente Yamada Sawamura14Marilia Seelaender15Michelle Louvaes Garcia16Orestes Vicente Forlenza17Rodolfo Furlan Damiano18Vanderson Geraldo Rocha19Linamara Rizzo Batisttella20Carlos Roberto Ribeiro de Carvalho21Claudia da Costa LeiteCristiano GomesEmmanuel A. BurdmannEuripedes C. MiguelGiovanni G. CerriGuilherme FonsecaJorge HallakLuis YuMaria Cassia J Mendes CorrêaMarcio ManciniMaria Elizabeth RossiRicardo Ferreira BentoRossana Pulcinelli FranciscoThiago Avelino-SilvaWilson Jacob FilhoEdivaldo M UtiyamaAluisio C SeguradoBeatriz PerondiAnna Miethke-MoraisAmanda C MontalLeila HarimaSolange R G FuscoMarjorie F SilvaMarcelo C RochaIzabel Cristina RiosFabiane Yumi Ogihara KawanoMaria Amélia de JesusCarolina CarmoClarice TanakaJulio F M MarchiniMaura Salaroli OliveiraThaís GuimarãesCarolina dos Santos LázariEster Sabino22Marcello MC MagriTarcisio E P Barros-FilhoMaria Cristina Peres Braido Francisco4Association of British NeurologistsHospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Rheumatology Division, Sao Paulo, BrazilFaculdade de Medicina FMUSP, Universidade de Sao Paulo, São Paulo, SP, Brazil1 Departamento de Medicina Preventiva, Universidade de Sao Paulo Faculdade de Medicina, Sao Paulo, BrazilDepartamento de Moléstias Infecciosas e Parasitárias, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilInstituto Central, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo HCFMUSP, Sao Paulo, BrazilDepartamento de Neurologia, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilDepartamento e Instituto de Psiquiatria, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilDiretoria Executiva dos LIMs, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilDepartamento de Dermatologia, Laboratório de Dermatologia e Imunodeficiências, Faculdade de Medicina e Instituto de Medicina Tropical de São Paulo, Sao Paulo, BrazilDepartamento de Moléstias Infecciosas e Parasitárias, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilInstituto Central, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo HCFMUSP, Sao Paulo, BrazilDepartamento de Clínica Médica, Laboratório de Emergências Clínicas, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilInstituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilInstituto de Radiologia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilDepartamento de Cirurgia, Laboratório de Pesquisa em Cirurgia Experimental, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilDepartamento de Cardio-Pneumologia, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilDepartamento e Instituto de Psiquiatria, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilDepartamento e Instituto de Psiquiatria, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilLaboratório de Genética e Hematologia Molecular, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilInstituto de Medicina Física e de Reabilitação, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilDepartamento de Cardio-Pneumologia, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil7Department of Infectious Diseases, School of Medicine and Institute of Tropical Medicine, University of São Paulo, São Paulo, BrazilIntroduction 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.https://bmjopen.bmj.com/content/11/6/e051706.full |
| spellingShingle | 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 Maria Cristina Peres Braido Francisco 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/6/e051706.full |
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