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

NCT04563156 | Unknown

• 1 other identifier: 4047553
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Quality of life questionnaire EQ-5D

  30, 120 days and 12 months after hospital discharge

• 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 Scale

  6 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

Study Arms (1)

Severe Covid-19 Survivors

Severe Covid-19 survivors previously admitted in the hospital

Diagnostic Test: Lung Function Test

Interventions

Lung Function Test DIAGNOSTIC_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

Also known as: Computerized tomography scan, Cardiopulmonary Exercise Testing

Severe Covid-19 Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo-HCFMUSP

São Paulo, 05403-000, Brazil

Location

Related 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. doi: 10.1590/s1807-59322011000600002.

  PMID: 21808854 BACKGROUND

• 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.

  PMID: 30535520 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Respiratory Function Tests; Exercise Test

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Ergometry; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 24, 2020
• Study Start: June 23, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)