Prospective study of a cohort of patients discharged after severe acute respiratory syndrome and COVID-19: epidemiological, clinical and functional aspects

The medium and long-term clinical outcomes and consequences of COVID-19 are still unclear. Knowing the possible clinical and functional sequela in patients who had pulmonary infections by SARS-Cov2 and who needed hospitalization and oxygen therapy can contribute to a better understanding of the evolution and impact of the disease, as well as to the management of these conditions. This project has as main objectives 1) assessment of incidence, etiology, and indicators of opportunity in cases of severe acute respiratory syndrome(SARS), and 2) assessment, in cases of confirmed COVID-19, of clinical, epidemiological, functional, radiological, and quality of life parameters related to acute manifestations; in patients with SARS and COVID-19 we aimed also 3) to evaluate the functional, radiological and quality of life in the medium and long term, and 4) to evaluate and to compare the effectiveness of a pulmonary telerehabilitation program in the exclusively remote versus face-to-face and remote modality in patients with respiratory dysfunction after hospitalization for COVID-19pneumonia. This is a prospective cohort of adult participants hospitalized with SARS consecutively at the Hospital de Clínicas (HC) of University of Campinas (Unicamp), from May1st, 2020 to May 1st, 2021. It is estimated that 600 cases of SARS will be included, of which 150 are confirmed for COVID-19. For objective 4, patients will be randomized to one of two groups, PTRP exclusively remote (GR-R) versus remote and face-to-face (GR-P), and it is intended to include 50 patients. Patients will be followed during hospitalization until discharge, transfer or death. After discharge, patients with SARS and COVID-19 will be followed up on an outpatient basis until the 12th month, with medical and physiotherapeutic evaluations, as well as laboratory, functional, and imaging tests. Persistently symptomatic patients will be invited to participate in the PTRP lasting 12 weeks, with assessment of functional capacity and quality of life before and at the end of the program. Clinical and therapeutic decisions will be made according to Unicamp's HC assistance protocol for COVID-19. Persistent symptomatic patients will be invited to participate in a Pulmonary Telerehabilitation Program. Primary outcomes will2be death, use of mechanical ventilation, functional respiratory dysfunction and quality of life. Secondary outcomes will be days in the ICU, days on mechanical ventilation, occurrence of infections related to health care, occurrence of pulmonary thromboembolism, readmission byCOVID-19, functional capacity. For objective 4, the outcomes analyzed will be functional capacity and quality of life. The data will be stored on the Red-Cap platform, a free platform for collecting and managing research data and clinical protocols whose function is to build and manage research and databases securely. The statistical analysis will be performed using the SPSS statistics package, Windows version 17.0.