Quality of life and long-term outcomes after hospitalization for COVID-19: Protocol for a prospective cohort study (Coalition VII)

Regis Goulart Rosa, Caroline Cabral Robinson, Viviane Cordeiro Veiga, Alexandre Biasi Cavalcanti, Luciano César Pontes de Azevedo, Flávia Ribeiro Machado, Otavio Berwanger, Álvaro Avezum, Renato Delascio Lopes, Thiago Costa Lisboa, Cassiano Teixeira, Fernando Godinho Zampieri, Bruno Martins Tomazini, Letícia Kawano-Dourado, Daniel Schneider, Denise de Souza, Rosa da Rosa Minho dos Santos, Sabrina Souza da Silva, Geraldine Trott, Bruna dos Passos Gimenes, Ana Paula de Souza, Bruna Machado Barroso, Lauren Sezerá Costa, Liége Gregoletto Brognoli, Melissa Pezzetti Pelliccioli, Nicole dos Santos Studier, Raíne Fogliati de Carli Schardosim, Tainá Aparecida Haubert, Victoria Emanuele Lobo Pallaoro, Debora Mariani de Oliveira, Pedro Isaacsson Velho, Gregory Saraiva Medeiros, Marcelo Basso Gazzana, Alexandre Prehn Zavascki, Paulo Márcio Pitrez, Roselaine Pinheiro de Oliveira, Carisi Anne Polanczyk, Luiz Antônio Nasi, Luciano Serpa Hammes, Maicon Falavigna

The long-term effects caused by COVID-19 are unknown. The present study aims to assess factors associated with health-related quality of life and long-term outcomes among survivors of hospitalization for COVID-19 in Brazil. This is a multicenter prospective cohort study nested in five randomized clinical trials designed to assess the effects of specific COVID-19 treatments in over 50 centers in Brazil. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed-up for a period of 1 year by means of structured telephone interviews. The primary outcome is the 1-year utility score of health-related quality of life assessed by the EuroQol-5D3L. Secondary outcomes include all-cause mortality, major cardiovascular events, rehospitalizations, return to work or study, physical functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living, dyspnea assessed by the modified Medical Research Council dyspnea scale, need for long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-Revised, and self-rated health assessed by the EuroQol-5D3L Visual Analog Scale. Generalized estimated equations will be performed to test the association between five sets of variables (1- demographic characteristics, 2- premorbid state of health, 3- characteristics of acute illness, 4- specific COVID-19 treatments received, and 5- time-updated postdischarge variables) and outcomes. The study protocol was approved by the Research Ethics Committee of all participant institutions. The results will be disseminated through conferences and peer-reviewed journals.