Follow-up and Rehabilitation of Survivors of Severe Coronavirus Disease 2019 (COVID-19) Infection — SegCov  

Covid19 Clinical Trial

Official title: Follow-up and Rehabilitation of Survivors of Severe Covid-19 Infection

Status Enrolling by invitation

Clinical Trial Summary

Infection with covid-19 is associated with respiratory failure, which when related to other etiologies can lead to reduced quality of life, physical, cognitive and mental dysfunction. There is no knowledge of the possible consequences of severe covid-19 infection.

Our objective is to describe these repercussions, identifying risk factors and assessing the impact of physical training.

At least 100 patients over 18 years of age who survive severe Covid-19 infection will be evaluated. Assessments after 1, 4, 6 and 12 months after hospital discharge. Quality of life, dyspnea, activity of daily living, muscle strength, mental and cognitive dysfunction will be evaluated, as well as pulmonary function test, cardiopulmonary stress test and chest tomography. Return to work, thromboembolic events and mortality up to 12 months will also be monitored.

Hospitalization data will be used to identify factors related to quality of life, fatigue and respiratory dysfunction. Predefined risk factors will be evaluated: age, sex, smoking, previous comorbidities index, previous clinical frailty, serum C-reactive protein and leukocyte / lymphocyte ratio in the first 24 hours of hospitalization, time between onset of symptoms and hospitalization, ICU and mechanical ventilation, time on mechanical ventilation, compliance corrected by the ideal weight at the start of mechanical ventilation, driving pressure, tidal volume corrected by the ideal weight and PEEP (positive end expiratory pressure) after 24 hours of intubation in controlled ventilation, tidal volume corrected by the ideal weight after 24 hours of spontaneous ventilation, inspiratory muscle training and pulmonary rehabilitation after hospital discharge.

Clinical Trial Description

Prospective longitudinal study in which survivors of severe infection with the covid-19 virus (need for hospitalization with supplementation of more than 3l / min of oxygen or mechanical ventilation) will be evaluated after 1 month, 4 months, 6 months and 1 year after hospital discharge through distance or face-to-face assessment.

Patients will be included according to a convenience sample until 12/31/2020 with follow-up until 12/31/2021. The EQ-5D questionnaire will be collected to assess quality of life. For other secondary outcomes, the clinical frailty scale, daily life independence scale, MoCA cognition questionnaire, hospital anxiety and depression questionnaire (HADS), muscle strength measure by the MRC scale, dyspnea measure by the mMRC and BDI scale will be used -TDI, 1-minute sit-and-stand test, maximum inspiratory and expiratory pressure measurement. Return to work, occurrence of thromboembolic events, occurrence of falls, need for re-hospitalization and mortality up to 12 months after admission will also be evaluated.

After 6 months of discharge, lung volume measurement will be performed by pulmonary function test, aerobic capacity by cardiopulmonary exercise test and evaluation of anatomical pulmonary sequelae by chest tomography. Patients residing close to the hospital will be offered a physical training program carried out by the physiotherapy team with assessment of functional response indicators.

The data obtained in the follow-up will be crossed with data obtained by the Epicov study in order to identify risk factors related to dysfunctions. ;

Related Conditions & MeSH terms

• Covid19
• Infection

• NCT number: NCT04563156
• Study type: Observational
• Source: University of Sao Paulo General Hospital
• Status: Enrolling by invitation
• Start date: June 23, 2020
• Completion date: December 31, 2021