Clinical trial NCT04563156: Follow-up and Rehabilitation of Survivors of Severe Coronavirus Disease 2019 (COVID-19) Infection
Official title: Follow-up and Rehabilitation of Survivors of Severe Covid-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: COVID19
LUNG FUNCTION
QUALITY OF LIFE
REHABILITATION
RISK FACTOR
FOLLOW-UP
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age whom was admitted at the Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo Faculty of Medicine Clinics Hospital) with positive RT-PCR for SARS CoV-2 swab that needed oxygen supplementation greater than 3L / min or mechanical ventilation and has been discharged from hospital after improvement.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Respiratory infection confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) for SARS CoV-2 swab
* Need for admission to the ICU or ward with need for oxygen greater than 3L / min or mechanical ventilation and has been discharged from hospital.

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Quality of life assessment of a survivor of severe COVID-19 infection 6 months after hospital discharge;
timeFrame: 6 months after discharge
Secondary outcomes:
measure: Quality of life questionnaire EQ-5D
timeFrame: 30, 120 days and 12 months after hospital discharge
measure: Evaluation of dyspnea by the Modified Medical Research Council Scale (mMRC)
timeFrame: 30, 120 days, 6 months and 12 months after hospital discharge
measure: The Hospital Anxiety and Depression Scale
timeFrame: 6 months and 12 months after hospital discharge
measure: Baseline and Transition Dyspnea Indexes (BDI-TDI)
timeFrame: 30 days, 120 days, 6 and 12 months after hospital discharge;
measure: Clinical frailty scale measured after discharge from the ICU,
timeFrame: 30, 120 days, 6 and 12 months after hospital discharge
measure: Lawton-Brody Instrumental Activities of Daily Living (iADL) scale
timeFrame: 30, 120 days, 6 months and 12 months after hospital discharge
measure: Muscle strength according to the Medical Research Council (MRC) scale
timeFrame: 30, 120 days, 6 and 12 months after hospital discharge;
measure: Maximum inspiratory pressure, diaphragmatic mobility and diaphragm thickness
timeFrame: 30, 120 days, 6 and 12 months after hospital discharge
measure: Sit-to-stand test in 1 minute
timeFrame: 30 days, 120 days, 6 and 12 months after hospital
measure: Cognitive dysfunction measured using the Montreal Cognitive Assessment (MoCA) test
timeFrame: 6 months and 12 months after hospital discharge
measure: Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements
timeFrame: 30, 120 days and 6 and 12 months after hospital discharge
measure: Hemoglobin, hematocrit, creatinine and Fasting plasma glucose (FPG)
timeFrame: 6 and 12 months after hospital discharge;
measure: Quantitative computerized tomography scan
timeFrame: 6 months after hospital discharge
measure: Maximum VO2 during Cardiopulmonary exercise testing
timeFrame: 6 and 12 months after hospital discharge
measure: Return to work
timeFrame: 6 months and 12 months after hospital discharge
measure: Occurrence of thromboembolic events after
timeFrame: 6 and 12 months after hospital discharge
measure: Occurrence of falls
timeFrame: 6 and 12 months after hospital discharge
measure: Need for readmission
timeFrame: 6 and 12 months after hospital discharge
measure: Mortality
timeFrame: 6 and 12 months after hospital discharge
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo-HCFMUSP
Study officials:
References:
citation: Toufen C Jr, Costa EL, Hirota AS, Li HY, Amato MB, Carvalho CR. Follow-up after acute respiratory distress syndrome caused by influenza a (H1N1) virus infection. Clinics (Sao Paulo). 2011;66(6):933-7. doi: 10.1590/s1807-59322011000600002.
citation: Toufen Junior C, De Santis Santiago RR, Hirota AS, Carvalho ARS, Gomes S, Amato MBP, Carvalho CRR. Driving pressure and long-term outcomes in moderate/severe acute respiratory distress syndrome. Ann Intensive Care. 2018 Dec 7;8(1):119. doi: 10.1186/s13613-018-0469-4.