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

Follow-up and Rehabilitation of Survivors of Severe Covid-19 Infection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04563156
Acronym
SegCov
Enrollment
100
Registered
2020-09-24
Start date
2020-06-23
Completion date
2021-12-31
Last updated
2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID19, LUNG FUNCTION, QUALITY OF LIFE, REHABILITATION, RISK FACTOR, FOLLOW-UP

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.

Interventions

DIAGNOSTIC_TESTLung Function Test

Lung Function Test at 1, 4, 6 and 12 months after discharge. Computerized tomography scan at 6 months after discharge. Cardiopulmonary Exercise Testing at 6 months after discharge

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life assessment of a survivor of severe COVID-19 infection 6 months after hospital discharge;6 months after dischargeEQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually. Assessment at 6 months after discharge

Secondary

MeasureTime frame
Evaluation of dyspnea by the Modified Medical Research Council Scale (mMRC)30, 120 days, 6 months and 12 months after hospital discharge
The Hospital Anxiety and Depression Scale6 months and 12 months after hospital discharge
Baseline and Transition Dyspnea Indexes (BDI-TDI)30 days, 120 days, 6 and 12 months after hospital discharge;
Clinical frailty scale measured after discharge from the ICU,30, 120 days, 6 and 12 months after hospital discharge
Lawton-Brody Instrumental Activities of Daily Living (iADL) scale30, 120 days, 6 months and 12 months after hospital discharge
Muscle strength according to the Medical Research Council (MRC) scale30, 120 days, 6 and 12 months after hospital discharge;
Maximum inspiratory pressure, diaphragmatic mobility and diaphragm thickness30, 120 days, 6 and 12 months after hospital discharge
Sit-to-stand test in 1 minute30 days, 120 days, 6 and 12 months after hospital
Cognitive dysfunction measured using the Montreal Cognitive Assessment (MoCA) test6 months and 12 months after hospital discharge
Quality of life questionnaire EQ-5D30, 120 days and 12 months after hospital discharge
Hemoglobin, hematocrit, creatinine and Fasting plasma glucose (FPG)6 and 12 months after hospital discharge;
Quantitative computerized tomography scan6 months after hospital discharge
Maximum VO2 during Cardiopulmonary exercise testing6 and 12 months after hospital discharge
Return to work6 months and 12 months after hospital discharge
Occurrence of thromboembolic events after6 and 12 months after hospital discharge
Occurrence of falls6 and 12 months after hospital discharge
Need for readmission6 and 12 months after hospital discharge
Mortality6 and 12 months after hospital discharge
Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements30, 120 days and 6 and 12 months after hospital discharge

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026