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

Covid19 Clinical Trial

— SegCov  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04563156
• Other study ID #: 4047553
• Status: Enrolling by invitation
• Start date: June 23, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Diagnostic Test:
• Lung 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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo-HCFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessment of a survivor of severe COVID-19 infection 6 months after hospital discharge;	EQ-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	6 months after discharge
Secondary	Quality of life questionnaire EQ-5D		30, 120 days and 12 months after hospital discharge
Secondary	Evaluation of dyspnea by the Modified Medical Research Council Scale (mMRC)		30, 120 days, 6 months and 12 months after hospital discharge
Secondary	The Hospital Anxiety and Depression Scale		6 months and 12 months after hospital discharge
Secondary	Baseline and Transition Dyspnea Indexes (BDI-TDI)		30 days, 120 days, 6 and 12 months after hospital discharge;
Secondary	Clinical frailty scale measured after discharge from the ICU,		30, 120 days, 6 and 12 months after hospital discharge
Secondary	Lawton-Brody Instrumental Activities of Daily Living (iADL) scale		30, 120 days, 6 months and 12 months after hospital discharge
Secondary	Muscle strength according to the Medical Research Council (MRC) scale		30, 120 days, 6 and 12 months after hospital discharge;
Secondary	Maximum inspiratory pressure, diaphragmatic mobility and diaphragm thickness		30, 120 days, 6 and 12 months after hospital discharge
Secondary	Sit-to-stand test in 1 minute		30 days, 120 days, 6 and 12 months after hospital
Secondary	Cognitive dysfunction measured using the Montreal Cognitive Assessment (MoCA) test		6 months and 12 months after hospital discharge
Secondary	Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements		30, 120 days and 6 and 12 months after hospital discharge
Secondary	Hemoglobin, hematocrit, creatinine and Fasting plasma glucose (FPG)		6 and 12 months after hospital discharge;
Secondary	Quantitative computerized tomography scan		6 months after hospital discharge
Secondary	Maximum VO2 during Cardiopulmonary exercise testing		6 and 12 months after hospital discharge
Secondary	Return to work		6 months and 12 months after hospital discharge
Secondary	Occurrence of thromboembolic events after		6 and 12 months after hospital discharge
Secondary	Occurrence of falls		6 and 12 months after hospital discharge
Secondary	Need for readmission		6 and 12 months after hospital discharge
Secondary	Mortality		6 and 12 months after hospital discharge